Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00667329
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • 2CdA — DRUG
    1.5 mg/m\^2 subcutaneous injection three times daily x 7 days.
  • Cyclophosphamide — DRUG
    40 mg/m\^2 PO twice daily x 7 days.
  • Rituximab — DRUG
    375 mg/m\^2 IV once weekly x 4 weeks.

Study Details

The goal of this clinical research study is to see how well the drugs 2CdA, cyclophosphamide, and rituximab (rituxan) shrink a lymphoma called Waldenstrom's macroglobulinemia. After these drugs are given for 2 courses, a second goal is to see how long a remission lasts. A third goal is to see how often repeat remissions can be achieved when the lymphoma returns later and the same drugs are restarted. This is an investigational study. The FDA has approved each of these drugs for the treatment of low-grade lymphoma. The combined use of these drugs for Waldenstrom's macroglobulinemia is investigational, although each drug has been effective by itself for this disease. About 50 patients will take part in this study. This study will take place only at UTMDACC (outpatient basis).

Key Dates

Start date
Jul 9, 1999
Status verified
Mar 2022
Primary completion
Feb 10, 2022
Completion
Feb 10, 2022

Study Design

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

Arms

  • Experimental: 2CdA + Cyclophosphamide + Rituximab
    2CdA 1.5 mg/m\^2 subcutaneous injection three times daily x 7 days. Cyclophosphamide 40 mg/m\^2 PO twice daily x 7 days. Rituximab 375 mg/m\^2 IV once weekly x 4 weeks.

Primary Outcome Measure

Response Rate [ Time Frame: two months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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