A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Patients With Chronic Lymphocytic Leukemia and Unfavourable Somatic Status

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01283386
First received: January 18, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This multi-center, randomized study will compare the efficacy and safety of MabT hera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in patients with previously untreated B-cell chronic lymphocyt ic leukemia and unfavourable somatic status. Patients will be randomized to rece ive Mabthera (375 mg/m2 intravenously [iv] Day 1 of Cycle 1, 500 mg/m2 iv Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 iv or 32 mg/m2 orally Days 1-3) an d cyclophosphamide (150 mg/m2 iv or orally Days 1-3) or with chlorambucil (10 mg

/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatmen t is 24 weeks.


Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: rituximab [MabThera]
Drug: fludarabine
Drug: cyclophosphamide
Drug: chlorambucil
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study to Compare Efficacy and Safety of RFC-lite (Rituximab, Fludarabine, Cyclophosphamide) Regimen With LR (Rituximab, Chlorambucil) as a First-line Therapy in Patients With B-cell Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Therapy response rate [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Safety:Incidence of adverse events [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Laboratory predictors of response [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: rituximab [MabThera]
375 mg/m2 iv on Day 1 of cycle 1, 500 mg/m2 iv on Day 1 of cycles 2-6 (28-day cycles)
Drug: fludarabine
20 mg/m2 iv or 32 mg/m2 orally Days 1-3 of each 28-day cycle, 6 cycles
Drug: cyclophosphamide
150 mg/m2 iv or orally on Days 1-3 of each 28-day cycle, 6 cycles
Active Comparator: B Drug: rituximab [MabThera]
375 mg/m2 iv on Day 1 of cycle 1, 500 mg/m2 iv on Day 1 of cycles 2-6 (28-day cycles)
Drug: chlorambucil
10 mg/m2 orally on Days 1-7 of each 28-day cycle, 6 cycles

  Eligibility

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

Inclusion Criteria:

  • Adult patients, 60-70 or >70 years of age
  • Cumulative Illness Rating Scale (CIRS) comorbidity score >/=7 if patient is 60-70 years old
  • Previously untreated B-cell chronic lymphocytic leukemia
  • Binet stage B, C or A with progression
  • ECOG performance status 0-2

Exclusion Criteria:

  • Small-cell lymphoma
  • Autoimmune hemolytic anemia
  • Concomitant malignant disease during enrollment, except for basal cell carcinoma of the skin
  • Chemotherapy for concomitant malignant disease within 12 months prior to study enrollment
  • Richter's syndrome
  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: NCT01283386

Contacts
Contact: Reference Study ID Number: ML25137 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Russian Federation
Recruiting
Irkutsk, Russian Federation, 664079
Recruiting
Kemerovo, Russian Federation, 650066
Terminated
Moscow, Russian Federation, 125284
Active, not recruiting
Moscow, Russian Federation, 115478
Recruiting
Saint-Petersburg, Russian Federation, 198205
Recruiting
St. Petersburg, Russian Federation, 197110
Completed
Tula, Russian Federation, 300053
Completed
UFA, Russian Federation, 450005
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: NCT01283386     History of Changes
Other Study ID Numbers: ML25137
Study First Received: January 18, 2011
Last Updated: July 7, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

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
Cyclophosphamide
Fludarabine
Fludarabine monophosphate
Rituximab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on July 23, 2014