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A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia

This study is currently recruiting participants.
Verified June 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01263704
First received: December 17, 2010
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This single arm, open-label study will assess the safety and efficacy of low dose fludarabine and cyclophosphamide in combination with standard dose MabThera/Rituxan (rituximab) as primary therapy in elderly patients (>/= 65 years) with chronic lymphocytic leukemia. Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375 mg/m2 intravenously [iv] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine (12.5 mg/m2 iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2 iv Days 1-3, cycles 1-6). Anticipated time on study treatment is 6 months, with a 30- months follow-up period.


Condition Intervention Phase
Lymphocytic Leukemia, Chronic
 Drug: rituximab [MabThera/Rituxan]
Drug: fludarabine
Drug: cyclophosphamide
 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 Phase II, Multicenter, Single Arm Study to Determine the Efficacy and Safety of Low Dose Fludarabine and Cyclophosphamide Combined With Standard Dose Rituximab as Primary Therapy in Elderly Untreated Patients (>/=65 Years Old) With Chronic Lymphocytic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall Response Rate (according to National Cancer Institute - Working Group [NCI-WG] guidelines) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events (especially neutropenic fever, infection rate, number of hospitalization days, thrombocytopenia >/= grade 3, neutropenia >/= grade 3)) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival (according to NCI-WG guidelines) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • Time to next treatment [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • Quality of life: Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: rituximab [MabThera/Rituxan]
375 mg/m2 iv Day 0 of Cycle 1, 500 mg/m2 iv Day 1 of Cycles 2-6
Drug: fludarabine
12.5 mg/m2 on Days 1-3 of every 28-day cycle, 6 cycles
Drug: cyclophosphamide
150 mg/m2 on Days 1-3 of each 28-day cycle, 6 cycles

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 65 years of age
  • Previously untreated B-cell chronic lymphocytic leukemia (CLL)
  • Binet stage C or active Binet stage A and B disease

Exclusion Criteria:

  • Prior treatment for CLL
  • CLL with transformation (Richter's syndrome)
  • Suspected or known CNS involvement of CLL
  • Impaired renal or hepatic function
  • HIV positivity, active hepatitis B/C, or any active or uncontrolled infections
  • Concomitant diseases requiring chronic steroid administration
  • Active second malignancy within the 2 years prior to study (except for non-melanoma skin cancer and in situ cervix or breast carcinoma)
  • ECOG performance status >/= 4
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263704

Contacts
Contact: Reference Study ID Number: ML25464 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Israel
Recruiting
Afula, Israel, 18101
Recruiting
Beer Sheva, Israel, 8410101
Recruiting
Haifa, Israel, 31096
Recruiting
Haifa, Israel, 33394
Recruiting
Jerusalem, Israel, 91120
Recruiting
Jerusalem, Israel, 91031
Recruiting
Kfar Saba, Israel, 44281
Recruiting
Nahariya, Israel, 22100
Recruiting
Petach Tikva, Israel, 49100
Recruiting
Rehovot, Israel, 76100
Recruiting
Rishon Lezion, Israel, 70300
Recruiting
Tel Aviv, Israel, 64239
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: NCT01263704     History of Changes
Other Study ID Numbers: ML25464
Study First Received: December 17, 2010
Last Updated: June 3, 2013
Health Authority: Israel: Ministry of Health, Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on June 18, 2013