Clinical trial · Interventional
Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)
Multicenter Phase II Trial of Fludarabine and Cyclophosphamide in Combination With Alemtuzumab (FC-Cam) for Patients With Relapsed Chronic Lymphocytic Leukemia - CLL-2L Protocol of the German CLL-Study Group (GCLLSG)
NCT00147901CI-TRIAL-00024125completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic 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 |
|---|---|---|---|
| B-cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FCCam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FCCam
- description
- After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles
- interventionNames
- Drug: FCCam
Primary outcomes (1)
- measure
- Overall response rate (complete and partial response rate)
- timeFrame
- 28 days after the end of the last cycle
- description
- Response Evaluation has to be done according the the NCI guidelines
Secondary outcomes (6)
- measure
- Toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * B-CLL in need of treatment * One or two prior prior therapies * WHO performance status 0-2 Exclusion Criteria: * Serum creatinine \> 1.5 ULN * Major organ dysfunctions * Pregnant or nursing
References
Publications (1)
- RESULTElter T, James R, Busch R, Winkler D, Ritgen M, Bottcher S, Kahl C, Gassmann W, Stauch M, Hasan I, Staib P, Fischer K, Fink AM, Bahlo J, Buhler A, Dohner H, Wendtner CM, Stilgenbauer S, Engert A, Hallek M. Fludarabine and cyclophosphamide in combination with alemtuzumab in patients with primary high-risk, relapsed or refractory chronic lymphocytic leukemia. Leukemia. 2012 Dec;26(12):2549-52. doi: 10.1038/leu.2012.129. Epub 2012 May 15. No abstract available. PMID 22584787