Clinical trial · Interventional
Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia
Randomized Phase III Trial Evaluating the Role of Autologous Stem Cell Transplantation in Previously Untreated Patients With Stage B and C Chronic Lymphocytic Leukemia
- 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)
Phase III trial evaluating the role of autologous stem cell transplantation in previously untreated patients under 65 years with stage B and C B-cell chronic lymphocytic leukemia. Endpoints of the trial : * major : progression free survival at 3 years * secondary : overall survival, tolerance, prognostic factors according to baseline clinical stage and biological characteristics (IgHv mutational status, expression of ZAP70 and CD38, cytogenetics).
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous stem cell transplantation | Procedure | — | UNRESOLVED |
| DHAP rescue and Autologous stem cell transplantation | Procedure | — | UNRESOLVED |
| DHAP rescue and F+C | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Complete responders
- description
- watch and wait policy
- type
- EXPERIMENTAL
- label
- arm 2: complete responders patients
- description
- ABMT : TBI, 10 grays d-3-1 \& cyclophosphamide 60 mg/sqm d-5-4
- interventionNames
- Procedure: Autologous stem cell transplantation
- type
- EXPERIMENTAL
- label
- Non CR patients arm 3
- description
- Rescue chemotherapy and ABMT (see arm 2)
- interventionNames
- Procedure: DHAP rescue and Autologous stem cell transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * patients with stage B \& C CLL, 18- 65 years. * previously untreated * given written informed consent Exclusion Criteria: * Childbearing women * OMS Performance status \> 2 * Binet stage A * Autoimmune hemolytic anemia * Active or previous (\< 5 years) malignant disease, except cutaneous cell carcinoma. * Previous CLL treatment * HIV seropositivity * Abnormal renal or liver function tests (creatinine \> 1,5N, transaminases \> 2N, bilirubin \> 1,5N) * Cardiac failure (ejection fraction \< 50%) * Lung disease or perturbed ventilation tests
References
Publications (1)
- RESULTLaurent Sutton, Sylvie Chevret, Karim Maloum, Olivier Tournilhac, Marine Diviné, Veronique Leblond, Bernadette Corront, Stephane Lepretre, Houchingue Eghbali, Eric Van Den Neste, Mauricette Michallet, Frederic Maloisel, Krimo Bouabdallah, Christian Berthou, Pauline Brice, Didier Decaudin, Hugo Gonzalez, Florence Nguyen Khac, Frederic Davi, Julie Lejeune, Helene Merle-Beral, Michel Leporrier, for the French Study Group on CLL, the SFGM -TC; Autologous Stem Cell Transplantation (ASCT) in CLL. Results of a Phase III Randomized Multicenter Trial.. Blood 2009; 114 (22): 878. doi: https://doi.org/10.1182/blood.V114.22.878.878