A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Chronic Lymphocytic Leukemia.

Lymphocytic Leukemia, Chronic Clinical Trial

Official title:

An Open-label Study to Characterize the Safety and Response Rate of MabThera (Rituximab) Plus Chlorambucil in Previously Untreated Patients With CD20-positive B-cell Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00532129
• Other study ID #: MO20927
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2007
• Last updated: December 1, 2015
• Start date: October 2007
• Est. completion date: April 2012

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: England: National Patient Safety Agency and Research Ethics Committees
• Study type: Interventional

Clinical Trial Summary

This single arm study will assess the safety and effect on response rate of a combination of MabThera and chlorambucil in previously untreated patients with B-cell chronic lymphocytic leukemia. Patients will receive 6x monthly cycles of combination treatment, followed by up to 6 cycles of chlorambucil alone. MabThera will be administered on day 1 of each cycle, at a dose of 375mg/m2 iv in cycle 1, and 500mg/m2 in subsequent cycles, and chlorambucil will be administered on days 1-7 of each cycle at a dose of 10mg/m2/day po. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• previously untreated patients with CD20-positive B-cell chronic lymphocytic leukemia;

• patients with progressive Binet stage B, or C requiring therapy according to NCI criteria;

• ECOG performance status <=2.

Exclusion Criteria:

• previous treatment for CLL;

• known concomitant hematological malignancy;

• transformation to aggressive B-cell malignancy;

• history of severe cardiac disease;

• known hypersensitivity or anaphylactic reactions to murine antibodies.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphocytic Leukemia, Chronic

Intervention

Drug:
• rituximab [MabThera/Rituxan]
375mg/m2 iv on day 1 of cycle 1; 500mg/m2 on day 1 of cycles 2-6

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE profile; laboratory parameters		Throughout study	No
Secondary	Tumor response rate, PFS, DFS, duration of response, overall survival, molecular remission.		Event driven	No