Clinical trial · Interventional
Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia
Chemo-Immunotherapy With Allogeneic Blood Stem Cell Transplantation in Patients With Chronic Lymphocytic Leukemia (Study #02)
- 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)
Patients with advanced chronic lymphocytic leukemia (CLL) have a poor long-term prognosis. Allogeneic stem cell transplantation (SCT) in patients with CLL has only rarely been performed in the past because the clinical outcome after myeloablative conditioning was poor, mainly due to the high treatment-related mortality. However long-term disease-free survival after allogeneic SCT has been reported. Recently it has been demonstrated by our group and others that non-relapse mortality can be reduced significantly with the use of reduced-intensity conditioning regimens. Yet, graft versus host disease (GVHD) remains an important problem in this setting. Alemtuzumab is an effective drug for the treatment of patients with advanced CLL and has been successfully applied for GVHD-prophylaxis in the setting of myeloablative and reduced-intensity conditioning regimens. The goal of the present study is to evaluate the role of alemtuzumab as part of a fludarabine-based reduced intensity conditioning regimen for allogeneic SCT in patients with advanced CLL.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Drug | Alemtuzumab | ALIAS |
| allogeneic stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- see detailed description
- interventionNames
- Procedure: allogeneic stem cell transplantation
- Drug: Alemtuzumab
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 400 days
Secondary outcomes (5)
- measure
- safety according to common toxicity criteria (CTC)
- timeFrame
- at discharge and until last follow up
- measure
- rate of primary and secondary graft failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * written informed consent * sufficient organ function * availability of an HLA-compatible donor (related or unrelated) * age \< 65 years * karnofsky index \> = 70% * B-CLL requiring treatment after failure of at least one prior cytostatic treatment Exclusion Criteria: * positive HIV-serology * pregnancy * intolerance to study drugs * second neoplasia * serious infections
References
Publications (0)
Data not yet available