Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of MabThera (Rituximab) in First Line Treatment of Chronic Lymphocytic Leukemia.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545714
First received: October 16, 2007
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This single arm study will assess the efficacy and safety of MabThera in combina tion with fludarabine and cyclophosphamide, followed by MabThera maintenance the rapy, as first line treatment of patients with chronic lymphocytic leukemia. Pat ients will receive 6 cycles of treatment with MabThera (375mg/m2 i.v. on day 1 o f cycle 1, and 500mg/m2 i.v. on day 1 of cycles 2-6), fludarabine (25mg/m2 on da ys 1-3) and cyclophosphamide (250mg/m2 on days 1-3). Patients with a partial or complete response will receive maintenance treatment with MabThera (375mg/m2 i.v every 2 months). The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals.


Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: rituximab [MabThera/Rituxan]
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: An Open Label Study to Assess the Effect of First Line Treatment With MabThera in Combination With Fludarabine and Cyclophosphamide, Followed by MabThera Monotherapy, on Response Rate in Patients With Chronic Lymphocytic Leukemia.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Response rate, and percentage of patients with molecular remission [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS, overall survival, treatment-free survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: November 2007
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Cyclophosphamide
250mg/m2 iv on days 1-3
Drug: Fludarabine
25mg/m2 on days 1-3
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv on day 1 of cycle 1; 500mg/m2 iv on day 1 of cycles 2-6

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-70 years of age;
  • CD20-positive B-cell chronic lymphocytic leukemia;
  • active disease;
  • no previous treatment.

Exclusion Criteria:

  • transformation to aggressive B-cell malignancy;
  • history of other malignancies except for localised skin cancer;
  • continuous systemic corticosteroid treatment;
  • known infection with hepatitis B or C.
  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: NCT00545714

Locations
Spain
Vitoria, Alava, Spain, 01009
Cádiz, Cadiz, Spain, 11009
Jerez de La Frontera, Cadiz, Spain, 11407
Santander, Cantabria, Spain, 39008
La Coruna, La Coruña, Spain, 15006
Alcorcon, Madrid, Spain, 28922
Mostoles, Madrid, Spain, 28935
Gandia, Valencia, Spain, 46702
Sagunto, Valencia, Spain, 46520
Bilbao, Vizcaya, Spain, 48013
Badajoz, Spain, 06080
Barcelona, Spain, 08907
Caceres, Spain, 10003
Castellon, Spain, 12004
Granada, Spain, 18014
Madrid, Spain, 28050
Madrid, Spain, 28041
Madrid, Spain, 28046
Madrid, Spain, 28007
Madrid, Spain, 28040
Madrid, Spain, 28222
Madrid, Spain, 28805
Madrid, Spain, 28905
Madrid, Spain, 28034
Malaga, Spain, 29010
Murcia, Spain, 30008
Salamanca, Spain, 37007
Valencia, Spain, 46026
Valencia, Spain, 46015
Valencia, Spain, 46017
Valencia, Spain, 46014
Zaragoza, Spain, 50009
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: NCT00545714     History of Changes
Other Study ID Numbers: ML21135
Study First Received: October 16, 2007
Last Updated: November 3, 2014
Health Authority: Spain: Agencia Espanola del Medicamento y Productos Sanitarios

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Rituximab
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014