Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00541034
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
  • cyclophosphamide — DRUG
  • pentostatin — DRUG

Study Details

RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving pentostatin together with cyclophosphamide and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving pentostatin together with cyclophosphamide and rituximab works in treating patients with previously untreated chronic lymphocytic leukemia.

Key Dates

Start date
May 31, 2005
Status verified
Jul 2017
Primary completion
Jan 31, 2016
Completion
Jan 31, 2016

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cyclophosphamide, pentostatin & rituximab
    Patients receive cyclophosphamide IV followed by pentostatin IV on day 1 in course 1. Beginning in course 2 and in all subsequent courses, patients receive cyclophosphamide IV on day 1, pentostatin IV on day 1, and rituximab IV on day 1 or on days 1 and 2. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Objective Response [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

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