Clinical trial · Interventional
MiniMUD Study - Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, treosulfan is evaluated for conditioning in allogenic stem cell transplantation. The procedure and the follow-up are the same as in standard allogenic transplant. The donor is unrelated (identical HLA). The graft is haematological peripheral blood stem cell. The conditioning with reduced intensity is: fludarabine (from day -6 to day -2), treosulfan (from day -6 to day -4) and thymoglobuline (from day -2 to day -1).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Transplantation | — | UNRESOLVED | — |
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| treosulfan | Drug | Treosulfan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival at 1 year
Secondary outcomes (5)
- measure
- Engraftment evaluation
- measure
- Acute and chronic graft-versus-host disease incidence and severity
- measure
- Response rate and survival without progression
- measure
- Evaluation of conditioning and transplant toxicity
- measure
- Chimerism evaluation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * AGE: \>= 18 years and \<= 65 years * Patients with a too high transplant-related mortality (TRM) after standard transplantation (multiple myeloma, chronic lymphoid leukemia, non Hodgkin's lymphoma, myelodysplasia) * Patients with visceral contra-indication for standard transplantation: * cardiac: myocardiopathy; forced expiratory volume (FEV) \< 50%; * respiratory: abnormal carbon monoxide diffusing capacity (DLCO); * renal: creatinine clearance \< 50ml/min; * hepatic: transaminases and bilirubin \> 2 upper normal limit; * infectious: controlled fungal infection. * Karnofsky score \>= 70% * Unrelated donor HLA identical (ABC, DRB1; DQB1) * Signed informed consent Diagnosis : Chronic myelogenous leukemia (CML): * In first chronic phase, resistant to interferon with or without aracytine or refractory or resistant to Glivec * In complete response (CR) or in 2nd partial response (PR) after being in blastic phase Multiple myeloma (MM): * Relapse after autograft if the therapeutic response was evaluated to 50% Non-Hodgkin's lymphoma (NHL): * Mantle cell lymphoma after first relapse but in case of chemosensitivity ≥ 50% except for high grade lymphoma * In 2nd CR or PR chemosensitive in response ≥ 50% after autograft Chronic lymphocytic leukemia (CLL): * In 2nd CR or PR or in response ≥ 50% after autograft or in 2nd relapse after 2 lines of treatment but in case of chemosensitivity ≥ 50% Acute myeloid leukemia (AML): * In 2nd CR or in 1st CR for high risk criteria \[high risk criteria defined by: LAM 7; leukocytes \> 30,000/mm3; chromosomal abnormalities: t(6,9); abnormalities of 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q et inv 3q\] Acute lymphoblastic leukemia (ALL): * In 2nd CR or in 1st CR if high risk criteria patients who are defined by chromosomal abnormalities t(9,22); t(1,19); t(4,11); abnormalities of 11q23 Myelodysplastic syndromes (MDS): * Patients without prior chemotherapy, with intermediate or high International Prognostic Scoring System (IPSS) score and blast cells \< 1% in bone marrow (BM) * CR or PR after chemotherapy for patients with 20 to 30% of blast cells in BM * Secondary AML patients with a response to chemotherapy (\< 30% blasts in BM and \< 5% of blast cells in blood) For all: * Adequate contraception in female patients of child bearing potential
References
Publications (0)
Data not yet available