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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01263704
First received: December 17, 2010
Last updated: November 3, 2014
Last verified: November 2014

December 17, 2010
November 3, 2014
July 2011
June 2016   (final data collection date for primary outcome measure)
Overall Response Rate (according to National Cancer Institute - Working Group [NCI-WG] guidelines) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01263704 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Quality of life: Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia
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

This single arm, open-label study will assess the safety and efficacy of low dos e fludarabine and cyclophosphamide in combination with standard dose MabThera/Ri tuxan (rituximab) as primary therapy in elderly patients (>/= 65 years) with chr onic 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/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles 1-6). Anticipated time on stud y treatment is 6 months, with a 30-month follow-up period.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphocytic Leukemia, Chronic
  • Drug: cyclophosphamide
    150 mg/m2 on Days 1-3 of each 28-day cycle, 6 cycles
  • Drug: fludarabine
    12.5 mg/m2 on Days 1-3 of every 28-day cycle, 6 cycles
  • Drug: rituximab [MabThera/Rituxan]
    375 mg/m2 iv Day 0 of Cycle 1, 500 mg/m2 iv Day 1 of Cycles 2-6
Experimental: Single Arm
Interventions:
  • Drug: cyclophosphamide
  • Drug: fludarabine
  • Drug: rituximab [MabThera/Rituxan]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
June 2016
June 2016   (final data collection date for primary outcome measure)

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 HBV surface antigen positive, or any active or uncontrolled infections
  • Patients with anti-HBV core antibodies (past infection with HBV) but who are negative for HBVsAg (either anti-HBS Ab positive or negative) and are positive for HBV-DNA by PCR analysis
  • 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 or prostate carcinoma)
  • ECOG performance status >/= 3
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01263704
ML25464
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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