Phase 2
N=86
Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00462332 ↗Enrolled (actual)
86
Serious AEs
18.6%
Results posted
Jul 2013
Primary outcome: Primary: Number of Patients With Complete Response — 14; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine (Drug); Campath (Drug); Transplant (Procedure)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Complete Response |
14; 3 | — |
| SECONDARY Toxicity |
— | — |
| SECONDARY Length of Survival |
1.57; 1.1 | — |
| SECONDARY Event-free Survival |
— | — |
| SECONDARY Disease-free Survival |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00462332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.