Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With CLL

Sponsor
Swiss Cancer Institute
Study ID
NCT00072007
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
    filgrastim
  • rituximab — BIOLOGICAL
    rituximab
  • CHOP regimen — DRUG
    CHOP regimen
  • cladribine — DRUG
    cladribine
  • cyclophosphamide — DRUG
    cyclophosphamide
  • doxorubicin hydrochloride — DRUG
    doxorubicin hydrochloride
  • prednisone — DRUG
    prednisone
  • vincristine sulfate — DRUG
    vincristine sulfate

Study Details

RATIONALE: Drugs used in chemotherapy, such as cladribine, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cladribine with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving cladribine and rituximab as remission induction therapy together with rituximab and stem cell mobilization in treating patients with chronic lymphocytic leukemia.

Key Dates

Start date
Jun 30, 2002
Status verified
May 2012
Primary completion
Mar 31, 2003
Completion
Oct 31, 2010

Study Design

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

Primary Outcome Measure

Complete-remission rate after induction [ Time Frame: 30 days ]

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