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

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

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of California-San Diego· La Jolla, CADana-Farber Cancer Institute· Boston, MA

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