Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)

G

German CLL Study Group

Status and phase

Completed
Phase 2

Conditions

B-cell Chronic Lymphocytic Leukemia

Treatments

Drug: FCCam

Study type

Interventional

Funder types

Other

Identifiers

NCT00147901
CLL-2L
2005-003017-32 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

61 participants in 1 patient group

FCCam
Experimental group
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
Treatment:
Drug: FCCam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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