A Study of Maintenance Treatment With MabThera (Rituximab) in Patients With Progressive B-cell Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00718549

First received: July 16, 2008

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 16, 2008

Last Updated Date

May 7, 2013

Start Date ^ICMJE

July 2009

Estimated Primary Completion Date

July 2019 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression-free survival in the maintenance phase [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00718549 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Complete response and partial response in induction phase [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Maintenance Treatment With MabThera (Rituximab) in Patients With Progressive B-cell Chronic Lymphocytic Leukemia

Official Title ^ICMJE

A Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With MabThera vs no Treatment, After Induction With MabThera, Cladribine and Cyclophosphamide on Progression-free Survival in Previously Untreated Patients With Progressive B-CLL. The Trial Conducted With PALG Sites

Brief Summary

This study will assess the effect of maintenance treatment with MabThera,in comparison with a 2 year observation period (no treatment),in patients with progressive B-cell chronic lymphocytic leukemia who have had previous first-line induction treatment with MabThera (RCC regimen).After 6 months of induction therapy with RCC (MabThera + cladribine + cyclophosphamide) patients will be randomized either to receive maintenance treatment with MabThera (375mg/m2 iv every 12 weeks, or to receive no treatment (observation only).The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Lymphocytic Leukemia, Chronic

Intervention ^ICMJE

Drug: rituximab [MabThera/Rituxan]
375mg/m2 on day 1 of cycle 1 (induction phase)
Drug: rituximab [MabThera/Rituxan]
500mg/m2 iv on day 1 of cycles 2-6 (induction phase)
Drug: cladribine
0.12mg/kg iv on days 2-4 of each cycle (induction phase)
Drug: cyclophosphamide
250mg/m2 iv on days 2-4 (induction phase)
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 12 weeks (maintenance phase)

Study Arm (s)

Experimental: 1
Interventions:
- Drug: rituximab [MabThera/Rituxan]
- Drug: rituximab [MabThera/Rituxan]
- Drug: cladribine
- Drug: cyclophosphamide
- Drug: rituximab [MabThera/Rituxan]
Active Comparator: 2
Interventions:
- Drug: rituximab [MabThera/Rituxan]
- Drug: rituximab [MabThera/Rituxan]
- Drug: cladribine
- Drug: cyclophosphamide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

128

Estimated Completion Date

July 2019

Estimated Primary Completion Date

July 2019 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients, 18-75 years of age;
confirmed diagnosis of B-cell chronic lymphocytic leukemia;
stage I-IV disease with evidence of progression;
no previous chemotherapy, radiotherapy or immunotherapy for B-cell chronic lymphocytic leukemia;
ECOG PS 0-2.

Exclusion Criteria:

active secondary malignancy or transformation to aggressive lymphoma;
medical condition requiring chronic use of oral corticosteroids at a dose of 1mg/kg or 60 mg/m2 over 2 weeks;
prior treatment with interferon, MabThera or another monoclonal antibody, immunosuppressive treatment or radiotherapy for 12 months before study start;
history of other malignancies within 2 years before study entry, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belarus, Poland

Administrative Information

NCT Number ^ICMJE

NCT00718549

Other Study ID Numbers ^ICMJE

ML21283, 2008-001140-39

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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