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

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)

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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