Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL.
- Trial ID
- 2025-522052-13-00
- Protocol
- FORUM2
Trial statistics
Diseases & Conditions
Objectives
The FORUM-2 platform trial aims to optimize the role of hematopoietic stem cell transplantation (HSCT) in acute lymphoblastic leukemia (ALL) by reducing treatment-related toxicity while preserving the essential graft-versus-leukemia (GVL) effect. The trial comprises multiple sub-studies with distinct primary objectives addressing different aspects of HSCT optimization in pediatric, adolescent, and young adult patients.
The primary objectives include:
• R1: To demonstrate non-inferiority of a reduced-intensity conditioning regimen consisting of 8 Gy total body irradiation (TBI) combined with etoposide compared to the standard 12 Gy TBI combined with etoposide in terms of survival outcomes in patients aged >2 to ≤25 years undergoing HSCT from either an HLA-identical sibling donor or an HLA-matched unrelated donor.
• R2: To compare the efficacy of ruxolitinib in combination with corticosteroids versus corticosteroids alone in terms of overall response rate at Day 28 in subjects with grade II-IV treatment-naïve acute graft-versus-host disease (aGVHD).
• S1: To compare the outcome of HSCT from HLA-mismatched donors after either post-transplant cyclophosphamide (PTCy) or TCRαβ/CD19 depletion GVHD prophylaxis in ALL patients up to 25 years old.
• O1: To evaluate the predictive power of EASIX (Endothelial Activation and Stress Index) for non-relapse mortality (NRM) in all patients enrolled in the FORUM-2 trial undergoing HSCT in ALL.
• O2: To evaluate the outcome in patients transplanted with an ABO major mismatch according to the standard procedure in the treatment center.
• P1: To evaluate the efficacy of up to four cycles of blinatumomab as post-HSCT maintenance therapy in reducing cumulative incidence of relapse in children under two years of age with CD19-positive B-ALL undergoing HSCT after a chemotherapy-based conditioning regimen.
Participants
The FORUM-2 platform trial plans to enroll a total of **250 participants** diagnosed with **acute lymphoblastic leukemia (ALL)** who have an indication for **allogeneic hematopoietic stem cell transplantation (HSCT)**. The study population includes both **male and female** patients ranging in age from **3 months to 25 years** at the time of transplantation. Participants are selected from patients enrolled in recognized national frontline protocols for ALL, including AIEOP-BFM ALL, ALLTogether, ALL-IC, IntReALL, ESPhall-COG, Interfant, and other established treatment frameworks. All patients must be in **complete remission** prior to HSCT, defined as less than 5% blasts in bone marrow and absence of leukemia cells in extramedullary sites. The trial includes patients receiving grafts from various donor types, including **HLA-matched sibling donors**, **HLA-matched unrelated donors**, **HLA-mismatched family donors**, and **cord blood** units meeting specified criteria. Female patients of childbearing potential must have a negative pregnancy test at screening, and all participants must agree to effective contraception during the study period. The trial excludes patients with a history of other malignancies. Different sub-studies within the platform have additional specific criteria related to age ranges, donor matching, conditioning regimens, and clinical conditions such as **acute graft-versus-host disease (aGVHD)** or **CD19 expression** on leukemia blasts, reflecting the multifaceted approach to optimizing HSCT outcomes in pediatric and young adult ALL patients.
Plans and Procedures
This is a multicenter interventional platform trial designed as a phase II-III study investigating the optimization of **hematopoietic stem cell transplantation** (HSCT) in pediatric patients with **acute lymphoblastic leukemia** (ALL). The trial employs multiple parallel sub-studies (R1, R2, S1, O1, O2, P1) to address different aspects of transplantation methodology and outcomes. The R1 sub-study utilizes a **randomized**, controlled design comparing reduced-intensity versus standard-intensity **total body irradiation** (TBI) conditioning regimens. The R2 sub-study is a randomized trial evaluating the addition of **ruxolitinib** to **corticosteroids** for treatment of **acute graft-versus-host disease** (aGVHD). The S1 sub-study compares outcomes between different **graft-versus-host disease** prophylaxis strategies in patients receiving transplants from HLA-mismatched donors. Observational sub-studies O1 and O2 evaluate predictive markers for **non-relapse mortality** and outcomes in ABO-incompatible transplantation, respectively. The P1 sub-study assesses **blinatumomab** as post-transplant maintenance therapy in infants under two years of age.
The trial investigates various medicinal products including **anti-t lymphocyte immunoglobulin** for solution for infusion, ruxolitinib as oral solution and tablets, **busulfan** concentrate for solution for infusion, **etoposide** solution for injection, methylprednisolone acetate, **cyclophosphamide** powder for solution for injection or infusion, **treosulfan** powder for solution for infusion, blinatumomab powder for concentrate and solution for infusion, **thiotepa** powder for concentrate for solution for infusion, and **fludarabine phosphate** powder for solution for injection or infusion. These products are administered via **intravenous** or oral routes depending on the specific agent. Maximum daily doses range from 2 mg/kg to 60 mg/kg for weight-based dosing, and from 20 mg to 28 micrograms for fixed dosing. Treatment periods vary from 1 day to 24 weeks depending on the sub-study and medicinal product.
Eligible participants include male and female patients aged 3 months to 25 years with an indication for **allogeneic transplantation** for ALL as determined by national frontline protocols. Patients must be in **complete remission** with less than 5% blasts and absence of **extramedullary** disease prior to HSCT. Specific sub-studies have additional eligibility criteria: R1 enrolls patients aged 2 to 25 years receiving transplants from matched donors; R2 includes patients under 18 years with grade II to IV treatment-naïve aGVHD; S1 enrolls patients receiving transplants from mismatched family donors; and P1 includes infants under 2 years with CD19-positive B-ALL. Female patients of childbearing potential must have negative pregnancy tests and all patients must agree to effective contraception during the study period.
The primary endpoints vary by sub-study. For R1, the primary endpoint is **event-free survival** (EFS) at year 4, defined as time from randomization or HSCT to relapse, death from any cause, or diagnosis of second malignant neoplasm. For R2, the primary endpoint is **overall response rate** at Day 28 after randomization, defined as complete or partial response without requirement for additional systemic therapies. For S1, EFS is measured from HSCT to relapse, **graft failure**, death, or second malignancy. For P1, the primary endpoint is **cumulative incidence of relapse** at 2 years after HSCT compared to historical controls. Study visits include screening assessments, conditioning regimen administration, HSCT procedure, and regular follow-up visits to monitor engraftment, disease status, and complications including graft-versus-host disease.
The estimated recruitment start date is October 2025, with an estimated study completion date of October 2032, indicating an overall trial duration of approximately 7 years. Individual participant involvement varies by sub-study, ranging from several weeks for conditioning and transplantation procedures to up to 4 years of follow-up in the R1 sub-study. Conditions that may lead to early termination from the study include disease relapse, unacceptable toxicity, development of second malignancies, graft failure, withdrawal of consent, pregnancy, or investigator decision based on patient safety considerations. Patients may also be withdrawn if they require prohibited concomitant medications or fail to comply with protocol requirements.
Treatment
The trial investigates multiple medicinal products used in hematopoietic stem cell transplantation for acute lymphoblastic leukemia. Experimental and auxiliary treatments are administered according to specific conditioning regimens and treatment protocols.
Ruxolitinib is administered as an experimental treatment in two pharmaceutical forms. Jakavi 5 mg/ml oral solution and Jakavi 5 mg tablets contain ruxolitinib as the active substance. Both formulations are administered via the oral route. The maximum daily dose is 20 mg, with a maximum total dose of 3360 mg over a treatment period of up to 24 weeks. Ruxolitinib is evaluated in combination with corticosteroids for the treatment of acute graft-versus-host disease.
Etoposide is administered as an experimental treatment. ETOPOSIDE TEVA 100 mg/5 ml solution for injection is provided as a solution for intravenous administration. The maximum daily dose is 60 mg/kg, with a maximum total dose of 3600 mg/kg administered over 1 day. Etoposide is used as part of conditioning regimens prior to transplantation.
Blinatumomab is administered as an auxiliary treatment. BLINCYTO 38.5 micrograms powder for concentrate and solution for infusion contains blinatumomab, a recombinant antibody derivative. The product is reconstituted and administered via intravenous infusion. The maximum daily dose is 28 micrograms, with a maximum total dose of 3136 micrograms over a treatment period of up to 16 weeks. This product has received orphan drug designation. Blinatumomab is evaluated as post-transplant maintenance therapy in pediatric patients with CD19-positive B-cell acute lymphoblastic leukemia.
Treosulfan is administered as an auxiliary treatment. Trecondi 1 g powder for solution for infusion contains treosulfan as the active substance. The product is administered via the intravenous route. The maximum daily dose is 14 grams per square meter body surface area, with a maximum total dose of 42 grams per square meter administered over 3 days. This product has received orphan drug designation. Treosulfan is used as part of conditioning regimens.
Busulfan is administered as an auxiliary treatment. Busulfan Tillomed 6 mg/ml concentrate for solution for infusion is provided as a concentrate that must be diluted before intravenous administration. The maximum daily dose is 4 mg/kg, with a maximum total dose of 19 mg/kg over 4 days. Busulfan is used in conditioning regimens prior to transplantation.
Cyclophosphamide is administered as an auxiliary treatment. Cyclophosphamide 500 mg powder for solution for injection or infusion is reconstituted and administered via the intravenous route. The maximum daily dose is 60 mg/kg, with a maximum total dose of 200 mg/kg over 4 days. Cyclophosphamide is used in conditioning regimens and for graft-versus-host disease prophylaxis.
Fludarabine phosphate is administered as a comparator treatment. Fludarabine 50 mg powder for solution for injection or infusion is reconstituted and administered intravenously. The maximum daily dose is 40 mg per square meter body surface area, with a maximum total dose of 160 mg per square meter over 5 days. Fludarabine is used as part of conditioning regimens.
Anti-T lymphocyte immunoglobulin (rabbit) is administered as an auxiliary treatment in two formulations. Grafalon 20 mg/ml concentrate for solution for infusion and Thymoglobuline 25 mg powder for solution for infusion both contain anti-T lymphocyte immunoglobulin derived from rabbits. These products are administered via the intravenous route. For Grafalon, the maximum daily dose is 5 mg/kg with a maximum total dose of 15 mg/kg over 3 days. For Thymoglobuline, the maximum daily dose is 3 mg/kg with a maximum total dose of 7 mg/kg over 3 days. These immunoglobulins are used for graft-versus-host disease prophylaxis.
Thiotepa is administered as an auxiliary treatment. Thiotepa Riemser 100 mg powder for concentrate for solution for infusion is reconstituted and administered intravenously. The maximum daily dose is 10 mg/kg, with a maximum total dose of 10 mg/kg administered over 1 day. Thiotepa is used in conditioning regimens.
Methylprednisolone acetate in combination with lidocaine hydrochloride monohydrate is administered as a comparator treatment. This corticosteroid combination is administered via the intravenous route. The maximum daily dose is 2 mg/kg, with a maximum total dose of 17 grams over a treatment period of up to 24 weeks. This treatment serves as the standard comparator for acute graft-versus-host disease management.
All medicinal products are administered according to protocol-specified schedules. Participant compliance is monitored throughout the treatment period according to standard clinical trial procedures. Dosing adjustments may be implemented based on individual patient characteristics including body weight, body surface area, and clinical response.
Efficacy
Efficacy will be assessed through multiple endpoints specific to each sub-study within the clinical trial. In the R1 sub-study, the primary endpoint is Event Free Survival (EFS) at year 4, measured from randomization or hematopoietic stem cell transplantation to the first failure event, which includes relapse, death from any cause, or diagnosis of a second malignant neoplasm. Patients without events will be censored at the last follow-up date. In the R2 sub-study, efficacy will be evaluated using overall response rate (ORR) at Day 28 after randomization, defined as the proportion of patients demonstrating complete response or partial response without requiring additional systemic therapies for earlier progression, mixed response, or nonresponse. Response scoring will be relative to the organ stage at randomization. The S1 sub-study will assess EFS from hematopoietic stem cell transplantation to the first failure event, including relapse, graft failure, death from any cause, or diagnosis of a second malignant neoplasm, with patients without events censored at last follow-up. The P1 sub-study will compare cumulative incidence of relapse (CIR) at 2 years after hematopoietic stem cell transplantation in blinatumomab-treated patients versus historical controls. CIR will be calculated from study enrollment until relapse, defined as bone marrow with at least 5% blasts or appearance of leukemia cells in an extramedullary site, or last follow-up, with death from causes other than leukemia relapse considered a competing event.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Inclusion Criteria applicable to All the patients • Male and female patients with allogenic transplant indication for ALL, as determined by national frontline protocols, including but not limited to: o AIEOP-BFM ALL 2017 or 2025 o ALLTogether o ALL-IC o IntReALL 2020 o ESPhall-COG o Interfant 2021 o Other recognized national frontline protocols. • Age ≥3 months to ≤25 years at the time of HSCT. • Patients must be in complete remission (with <5% blasts and absence of leukemia cells in extramedullary sites) prior to undergoing HSCT. • Selected donor must be either a matched donor (matched donor category includes 9/10 identical siblings and 10/10 or 9/10 HLA-matched unrelated donors) or a mismatched family donor (≤8/10 HLA match). Both bone marrow or peripheral blood stem cell grafts are permitted. Cord blood is permitted, as well, provided that the unit is at least 6/8 HLA matched and with a cryopreserved cellularity of at least 3x107 nucleated cells/Kg recipient body weight. • Female patients of childbearing potential must have a negative pregnancy test at screening, and all patients must agree to adhere to effective contraception during the study period. • Written study informed consent and/or assent from the patient and/or the parent, or guardian at the time of screening. • No history of other malignancies.
- R1 Sub-Study Inclusion Criteria • Subjects enrolled in the FORUM2 platform trial. • Patients ≥2 years to ≤ 25 years of age at the time of informed consent. • Selected donor must be a matched donor (matched donor category includes 10/10 identical siblings and 10/10 or 9/10 HLA-matched unrelated donors). Both bone marrow or peripheral stem cell grafts are permitted. Related donor cord blood is permitted, as well, if the unit has a cryopreserved cellularity of at least 3x107 nucleated cells/Kg recipient body weight. • Written study informed consent and/or assent from the patient and the parent or guardian at the time of screening. • Fulfilment of the inclusion criteria of the FORUM 2 platform trial
- R2 Sub-Study Inclusion Criteria • Subjects enrolled in the FORUM2 platform trial. • Patients ≥3 months to < 18 years of age at the time of informed consent. • Patients who have received an unmanipulated allogeneic bone marrow or peripheral blood transplant from a matched donor (matched donor category includes ≥9/10 related or unrelated donors). Recipients of either TBI-based (irrespective of the intensity) or chemo- conditioning regimens are eligible. • Clinically suspected grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT. Biopsy confirmation of aGvHD is recommended whenever possible but is not mandatory. Enrollment should not be delayed awaiting biopsy or pathology results and, in cases where a biopsy cannot be obtained or is clinically contraindicated, clinical suspicion of acute GVHD by the treating physician is sufficient, provided that alternative diagnoses are adequately ruled out. • Evidence of myeloid engraftment (ANC ≥ 0.5 × 109/L for 3 consecutive days). Use of growth factor supplementation is allowed. • Able to swallow and retain oral medication. • Written study informed consent and/or assent from the patient and the parent or guardian at the time of screening
- S1 Sub-Study Inclusion Criteria • Subjects enrolled in the FORUM2 platform trial. • Patients ≥3 months to ≤25 years of age at the time of informed consent. • Selected donor must be a mismatched family donor (≤8/10 HLA match). • GvHD prophylaxis based on either in-vivo PTCy or ex vivo αβ T-Cell depletion. • Use of the conditioning regimens specified in the specific study. • Written study informed consent and/or assent from the patient and the parent or guardian at the time of screening
- P1 Sub-Study Inclusion Criteria • Subjects enrolled in the FORUM2 platform trial. • Patients < 2 years of age at HSCT • Evidence of CD19 expression on leukemia blasts prior to HSCT. Previous treatment with blinatumomab and any other CD19-directed immunotherapy during front-line treatment before the allograft is not considered an exclusion criterion. • Patients who have received an allogeneic bone marrow or peripheral blood HSCT from a matched donor (matched donor category includes ≥9/10 related or unrelated donors) or mismatched related donors (i.e., HLA-hapoidentical donor). • Morphological bone marrow complete remission at time of enrollment, independently from MRD levels (both before and after HSCT) and independently from the presence of recurrent molecular lesions, such as KMT2A rearrangements. • No evidence of CNS active disease (i.e., CNS1) or any extramedullary localization of leukemia cells at time of study enrolment. Patients with previous CNS leukemia involvement are eligible if CNS was successfully treated prior to enrollment. • Written study informed consent and/or assent from the patient and/or the parent, or guardian at the time of screening
- O1 Sub-Study Inclusion Criteria • Subjects enrolled in the FORUM2 platform trial. • Patients ≥3 months to ≤25 years of age at the time of informed consent. • Written study informed consent and/or assent from the patient and the parent or guardian at the time of screening
- O2 Sub-Study Inclusion Criteria • Subjects enrolled in the FORUM2 platform trial. • Patients ≥3 months to ≤25 years of age at the time of informed consent. • Patients expected to receive bone marrow allografts with ABO major incompatibility from either matched donors or mismatched family donors • Written study informed consent and/or assent from the patient and the parent or guardian at the time of screening
Exclusion Criteria
- Exclusion Criteria applicable to all the patients • Patients < 3 months and > 25 years of age at the time of HSCT. • Patients not in complete morphological remission at the time of enrollment. • Patients with an initial diagnosis of Non-Hodgkin Lymphoma (NHL). • Patients with ALL as a secondary malignancy. • Patients with a history of previous autologous or allogeneic HSCT (prior allogeneic transplantation is permitted for subjects receiving post-transplant interventions, such as those enrolled in the R2 and P1 study, provided that this is their first allogeneic HSCT). • Female patients who are pregnant or breast feeding. • Fertile male or female patients of childbearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of contraception. • Active clinically uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no physical or radiographic signs of infection progression are present. • Active HBV or HCV infection that requires treatment, or at risk for HBV reactivation (ie, positive HBsAg). Subjects with negative HbsAg and positive total HB core antibody may be included if HBV DNA is undetectable at the time of screening. Subjects who are positive for HCV antibody are eligible only if polymerase chain reaction test is negative for HCV RNA. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment. Prior serology results are acceptable for determining eligibility. • Known human immunodeficiency virus infection (HIV). • Significant respiratory disease including patients who are on mechanical ventilation or who have resting O2 saturation <90% by pulse-oximetry on room-air. • Presence of severely impaired renal function (confirmed within 72 hrs prior to study treatment start) defined by: o Glomerular Filtration Rate (GFR) < 30 mL/min/1.73 m2 using estimated creatinine clearance calculated by updated bedside Schwartz equation or Cockroft Gault equation • Or o Renal dialysis requirement • Clinically significant or uncontrolled cardiac disease including any of the following: o - Uncontrolled hypertension o - New York Heart Association Class III or IV congestive heart failure o - Clinically significant cardiac arrhythmias • Severe hepatic insufficiency, defined by any of the following: o Child-Pugh Class C liver disease o AST (aspartate aminotransferase) or ALT (alanine aminotransferase) levels > 5 times the upper limit of normal (ULN), unless attributable to GvHD o Total bilirubin > 3.0 mg/dL, unless attributable to GvHD o INR (International Normalized Ratio) ≥ 1.7 o Clinical evidence of hepatic encephalopathy or ascites • Presence of severe concomitant constitutional disease that precludes treatment as per protocol, based on the investigator’s judgment. Examples include but are not limited to: Down syndrome with severe comorbidities, significant cardiac malformations, metabolic disorders affecting treatment feasibility. • Underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere participation in the study, pose a significant risk to the patient or interfere with interpretation of study data. • Karnofsky or Lansky performance score <50%, indicating significant functional impairment. • Patients who are unwilling or unable to comply with study procedures, including follow-up requirements and treatment schedules.
- R1 Sub-Study Exclusion Criteria • Patients not enrolled in the FORUM 2 platform trial (independently of the reason). • Patients <2 years or > 25 years of age at the time of informed consent. • Use of an unrelated cord blood unit or a mismatched family donor as the stem cell source • Patients who received CNS irradiation at a dose of 18 Gy within 12 months prior to HSCT, if the combined total dose from prior CNS irradiation and planned TBI conditioning will exceed 24 Gy. • Patient meets one or more of the exclusion criteria defined in the FORUM 2 platform trial
- R2 Sub-Study Exclusion Criteria • Patients not enrolled in the FORUM 2 platform trial (independently of the reason) • Patients <3 months of age or ≥ 18 years. • Patients transplanted from mismatched family donor (≤8/10 HLA match) or related/unrelated CB. • Patients having received any prior systemic treatment of aGvHD except for a maximum 72h of prior systemic corticosteroid therapy after the onset of acute GvHD. Patients are allowed to have received prior GvHD prophylaxis which is not counted as systemic treatment (as long as the prophylaxis was started prior to the diagnosis of aGvHD) • Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome with both acute and chronic GvHD features • Failed prior allogeneic HSCT, including previous primary or secondary graft failure • Acute GvHD occurring after non-scheduled donor leukocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. • Presence of overt relapse of primary malignancy, requiring either additional treatment after allogeneic HSCT or rapid immune suppression tapering/withdrawal • Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization. • Cholestatic disorders, or unresolved sinusoidal obstructive syndrome/veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to aGvHD and ongoing organ dysfunction). • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
- S1 Sub-Study Exclusion Criteria • Patients not enrolled in the FORUM 2 platform trial (independently of the reason) • Patients <3 months or > 25 years of age at the time of informed consent. • Any type of GvHD prophylaxis other than in-vivo PTCy or ex vivo αβ T-Cell depletion
- P1 Sub-Study Exclusion Criteria • Patients not enrolled in the FORUM 2 platform trial (independently of the reason) • Patients ≥ 2 years of age at HSCT • Patients not in complete remission at the time of enrollment • Presence of transplant-associated thrombotic microangiopathy • Previous diagnosis of SOS/VOD not resolved since at least 3 weeks before study inclusion • Presence of idiopathic pneumonia syndrome • Ongoing immunosuppression for reasons other than standard GVHD prophylaxis • Patients who received TBI as part of their conditioning regimen or a chemotherapy-based conditioning regimen other than busulfan, thiotepa and fludarabine or treosulfan, thiotepa and fludarabine or busulfan and cyclophosphamide (±VP16). • Presence of active grade III-IV acute GVHD at the time of enrollment. • Presence of grade II acute GVHD with either gastrointestinal or liver involvement. • Clinically relevant active infections, including unresolved bacterial, fungal, or parasitic infections or active uncontrolled viral reactivations (e.g., CMV, EBV, or adenovirus). • ANC <0.5 × 109/L or self-sustained platelet count <30 x 109/L at time of study enrolment, • Creatinine clearance lower than 30 ml/min or serum bilirubin > 3 x ULN prior to start of treatment (unless related to Gilbert’s or Meulengracht disease). • Lansky performance status < 50. • Patients transplanted from related/unrelated CB.
- O1 Sub-Study Exclusion Criteria • Patients not enrolled in the FORUM 2 platform trial (independently of the reason) • Patients <3 months or > 26 years of age at the time of informed consent.
- O2 Sub-Study Exclusion Criteria • Patients not enrolled in the FORUM 2 platform trial (independently of the reason) • Patients <3 months or > 25 years of age at the time of informed consent. • Graft source represented by peripheral blood stem cells
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Austria | Not Yet Recruiting | 01 Oct 2025 | 40 |
 Belgium | Not Yet Recruiting | 01 Oct 2025 | 25 |
 Czechia | Not Yet Recruiting | 01 Oct 2025 | 40 |
 Denmark | Not Yet Recruiting | 01 Oct 2025 | 20 |
 Finland | Not Yet Recruiting | 01 Oct 2025 | 40 |
 France | Not Yet Recruiting | 01 Oct 2025 | 150 |
 Germany | Not Yet Recruiting | 01 Oct 2025 | 180 |
 Hungary | Not Yet Recruiting | 01 Oct 2025 | 30 |
 Italy | Recruiting | 01 Oct 2025 | 120 |
 Norway | Not Yet Recruiting | 01 Oct 2025 | 25 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Thiotepa Riemser 100 mg powder for concentrate for solution for infusion | Other | POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION | INTRAVENOUS | 10 | 1 | PRD8842851 |
ETOPOSIDE TEVA 100 mg/5 ml, solution injectable pour perfusion | Test | SOLUTION INJECTABLE POUR PERFUSION | INTRAVENOUS | 60 | 1 | PRD724181 |
Trecondi 1 g powder for solution for infusion | Other | POWDER FOR SOLUTION FOR INFUSION | INTRAVENOUS | 14 | 3 | PRD7427531 |
Grafalon 20 mg/ml concentrate for solution for infusion. | Other | CONCENTRATE FOR SOLUTION FOR INFUSION | INTRAVENOUS | 5 | 3 | PRD12101032 |
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion | Test | POWDER FOR CONCENTRATE AND SOLUTION FOR SOLUTION FOR INFUSION | INTRAVENOUS INFUSION | 28 | 16 | PRD3418639 |
Jakavi 5 mg/ml oral solution | Test | ORAL SOLUTION | ORAL | 20 | 24 | PRD11956356 |
Thymoglobuline 25 mg powder for solution for infusion. | Other | POWDER FOR SOLUTION FOR INFUSION | INTRAVENOUS | 3 | 3 | PRD440933 |
Fludarabine 50mg Powder For Solution For Injection Or Infusion | Other | POWDER FOR SOLUTION FOR INJECTION OR INFUSION | INTRAVENOUS | 40 | 5 | PRD8590667 |
Cyclophosphamide 500 mg Powder for Solution for Injection or Infusion | Other | POWDER FOR SOLUTION FOR INJECTION OR INFUSION | INTRAVENOUS | 60 | 4 | PRD1649348 |
Jakavi 5 mg tablets | Test | TABLETS | ORAL | 20 | 24 | PRD3949640 |