Clinical trial · Interventional
Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Phase II Study of a Reduced-toxicity " Submyeloablative " Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
NCT00841724CI-TRIAL-00006929ITT 08-01completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
The goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine, Busulfan, Thymoglobuline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- Busilvex, Fludara, Thymoglobuline
- description
- D-6: Fludara D-5: Fludara + Busilvex D-4: Fludara + Busilvex D-3: Fludara + Busilvex D-2: Fludara + Thymoglobuline D-1: Thymoglobuline D0: graft infusion
- interventionNames
- Drug: Fludarabine, Busulfan, Thymoglobuline
Primary outcomes (1)
- measure
- Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation
- timeFrame
- 12 months after transplantation
Secondary outcomes (1)
- measure
- To assess the "classical" criteria (clinical and biological) associated with outcome after allogeneic stem cell transplantation. To evaluate the impact of the modified Charlson comorbidity score (Sorror Score) on TRM and 1-year overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients affiliated to a social security reimbursement system * Adults (men or women) aged between 18 and 65 years * Negative test for pregnancy * ECOG 0-1 or Karnofsky Index ≥ 70% * Availability of an HLA-identical sibling donor, or an HLA-matched unrelated donor (10/10 HLA compatibility in A, B, C, DRB1, DQB1 (a single allelic mismatch at the level of Cw can be accepted) * Life expectancy \> 6 months * Signed informed consent * Diagnosis of an hematological malignancy that is considered to be eligible for an allogeneic stem cell transplantation Exclusion Criteria: * Pregnant woman or not willing to take effective contraception * Classical contra-indications to the allogeneic stem cell transplantation procedure * Any contra-indication to the use of the drugs contained within the conditioning regimen according to the summary of product characteristics * Patients aged \< 50 years and deemed to be eligible for a "standard" or conventional myeloablative conditioning regimen * An HLA-matched sibling donor who has a contra-indication for stem cell mobilization and collection * History of uncontrolled psychiatric condition * Patients who have participated to another trial testing an experimental drug within one month prior to inclusion in this protocol.
References
Publications (1)
- RESULTMohty M, Malard F, Blaise D, Milpied N, Furst S, Tabrizi R, Guillaume T, Vigouroux S, El-Cheikh J, Delaunay J, Le Gouill S, Moreau P, Labopin M, Chevallier P. Reduced-toxicity conditioning with fludarabine, once-daily intravenous busulfan, and antithymocyte globulins prior to allogeneic stem cell transplantation: results of a multicenter prospective phase 2 trial. Cancer. 2015 Feb 15;121(4):562-9. doi: 10.1002/cncr.29087. Epub 2014 Oct 3. PMID 25283774