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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00738374
First received: August 18, 2008
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia. During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment. The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals.


Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: rituximab [MabThera/Rituxan]
Drug: chlorambucil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Chlorambucil Plus MabThera as Induction Therapy Followed in Responders by Maintenance Therapy Versus Observation on Response Rate in Patients >=60 Years With Previously Untreated Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall tumor response at end of induction phase [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response, partial response at end of induction phase [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Overall tumor response, complete response, partial response at end of maintenance phase [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • Event-free survival, progression-free survival, duration of response, disease-free survival, overall survival, time to new treatment or death. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, ECG, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: November 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase).
Drug: chlorambucil
8mg/m2 po on days 1-7 of courses 1-8

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=60 years of age;
  • CD20+ chronic lymphocytic leukemia (CLL);
  • no previous treatment for CLL;
  • ECOG performance status 0-1.

Exclusion Criteria:

  • co-morbid conditions requiring long term use of systemic corticosteroids during study treatment;
  • history of severe cardiac disease;
  • transformation to aggressive B-cell malignancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738374

Locations
Italy
Bari, Italy, 70124
Bologna, Italy, 40138
Catania, Italy, 95124
Catanzaro, Italy, 88100
Cosenza, Italy, 87100
Ferrara, Italy, 44100
Firenze, Italy, 50135
Genova, Italy, 16132
Messina, Italy, 98165
Milano, Italy, 20122
Milano, Italy, 20162
Napoli, Italy, 80131
Padova, Italy, 35128
Reggio Calabria, Italy, 89100
Roma, Italy, 00161
Roma, Italy, 00144
Siena, Italy, 53100
Torino, Italy, 10126
Verona, Italy, 37134
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00738374     History of Changes
Other Study ID Numbers: ML21445, 2008-001612-20
Study First Received: August 18, 2008
Last Updated: July 1, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Chlorambucil
Rituximab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 20, 2014