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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00147901

Enrollment

Registered

2005-09-07

Start date

2005-01-31

Completion date

2011-11-30

Last updated

2016-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell Chronic Lymphocytic Leukemia

Keywords

CLL, Immunochemotherapy

Brief summary

This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.

Interventions

DRUGFCCam

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overall response rate (complete and partial response rate)	28 days after the end of the last cycle	Response Evaluation has to be done according the the NCI guidelines

Secondary

Measure	Time frame
MRD response rate	28 days after the end of the last cycle
Response rate in biological defined risk groups	28 days after the end of the last cycle
Toxicity	28 days following the last dose of FCCam
Treatment administration (dose intensity)	up to the last day of the last given cycle (day 28 of the 6th cycle)
Overall survival	up to 36 months after the end of treatment
Duration of response	up to 36 months after the end of treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026