Clinical trial · Interventional
Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia
Phase II Pilot Trial to Evaluate the Efficacy of a Combined Therapy Approach for Young CLL Patients With Advanced and Progressive Disease Stratified According to the Biological Prognostic Features
- 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)
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. A peripheral stem cell transplant using stem cells from the patient or a donor may replace the patient's immune cells that were destroyed by chemotherapy. PURPOSE: This phase II trial is studying how well giving fludarabine together with alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic leukemia.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Campath | Drug | Alemtuzumab | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High risk patientes
- description
- Category of risk will be defined according to biological features.
- interventionNames
- Drug: Fludarabine
- Drug: Campath
- Procedure: Transplant
- type
- EXPERIMENTAL
- label
- Low risk patients
- description
- Category of risk will be defined according to biological features.
- interventionNames
- Drug: Fludarabine
- Drug: Campath
Primary outcomes (1)
- measure
- Number of Patients With Complete Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of chronic lymphocytic leukemia (CLL) * Advanced or progressive disease with ≥ 2 active clinical signs PATIENT CHARACTERISTICS: * Fertile patients must use adequate contraception * No positive Coomb's test with signs of hemolysis * No active infection * No uncontrolled severe disease * No known hypersensitivity or anaphylactic reactions to murine antibodies or proteins * No other malignancies within the past 2 years except for adequately treated malignancies * No significant traumatic injury within the past 4 weeks * No coexisting medical or psychological condition that would limit study compliance PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior treatment for CLL * No major surgery within the past 4 weeks * No prior chemotherapy
References
Publications (0)
Data not yet available