Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Richter's Syndrome, Refractory CLL and PLL

Part of paid clinical trials in La Jolla, California.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00452374
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cytarabine — DRUG
    1 g/m\^2 given IV for two days (Days 2 and 3).
  • Fludarabine — DRUG
    30 mg/m\^2 given IV for two days (Days 2 and 3).
  • Oxaliplatin — DRUG
    Starting dose of 17.5 mg/m\^2 IV for 4 days (Days 1 through 4).
  • Rituximab — DRUG
    375 mg/m\^2 IV on Day 3 of the first cycle over 4-6 hours and on Day 1 on every cycle following.

Study Details

Primary Objectives: 1. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of oxaliplatin in combination with fludarabine, Ara-C and rituximab in patients with Richter's transformation, prolymphocytic leukemia (PLL), or refractory/relapsed B-cell chronic lymphocytic leukemia (CLL). 2. Assess the complete response (CR) and partial response (PR) rate to combination therapy of oxaliplatin, fludarabine, Ara-C and rituximab in patients with Richter's transformation, PLL or refractory/relapsed B-cell CLL. 3. Determine the safety and toxicity profile of combination therapy of oxaliplatin, fludarabine, Ara-C and rituximab in patients with Richter's transformation, PLL or refractory/relapsed B-cell CLL. Secondary Objectives: 1. Determine the duration of response, failure-free survival, and overall survival. 2. Determine the incidence of infections (bacterial, fungal, and viral) in patients with Richter's transformation, prolymphocytic leukemia or refractory/relapsed B-cell CLL treated with rituximab, oxaliplatin, fludarabine and Ara-C; monitor immune parameters such as T cell counts and immunoglobulin levels; and monitor Epstein-Barr virus (EBV) status. 3. Characterize the pharmacodynamics of oxaliplatin in leukemia cells with respect to total adduct formation, cross-link formation and excision deoxyribonucleic acid (DNA) responses. Compare these parameters in cells from the same patient after treatment with oxaliplatin in combination with fludarabine and Ara-C.

Key Dates

First listed
Mar 27, 2007
Start date
Nov 30, 2004
Status verified
Oct 2011
Primary completion
Jan 31, 2011
Completion
Jan 31, 2011

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oxaliplatin, Fludarabine, Cytarabine + Rituximab
    Starting dose oxaliplatin 17.5mg/m\^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m\^2 IV and Cytarabine 1 g/m\^2 IV for two days, + Rituximab 375 mg/m\^2 IV on Day 3, Cycle 1 then Day 1 following cycles.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) Oxaliplatin [ Time Frame: From treatment onset to end of each cycle of treatment (every 21 days) ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of California-San DiegoLa JollaCalifornia92093-
Dana-Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in La Jolla, CA

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OncologyBlood cancer
By research site
University of California-San Diego· La Jolla, CADana-Farber Cancer Institute· Boston, MA

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