Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00667329
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
271.1
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Detailed Description

Before the study starts, patients will have a complete exam. Blood and urine tests will be done. A bone marrow test, a chest x-ray and a CT scan of the abdomen will be done if not studied recently.

Blood tests will be repeated after 14, 21, and 42 days. Provided the disease has responded, another bone marrow sample will be taken to confirm remission. X-rays may be repeated for the same reason.

The patient or a family member will be taught to inject 2CdA under the skin three times a day for 7 days. The patient will also take cyclophosphamide by mouth twice each day. Rituxan will be given by vein once weekly for 4 weeks after a test infusion on the day prior to the first injection. A second course of the 3 drugs will be given about 6 weeks after the start of the first course. All patients with improving disease will then be followed without further treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Primary Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab
Actual Study Start Date :
Jul 9, 1999
Actual Primary Completion Date :
Feb 10, 2022
Actual Study Completion Date :
Feb 10, 2022

Arms and Interventions

ArmIntervention/Treatment
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.

Drug: 2CdA
1.5 mg/m^2 subcutaneous injection three times daily x 7 days.
Other Names:
  • Leustatin
  • Cladribine
  • Drug: Cyclophosphamide
    40 mg/m^2 PO twice daily x 7 days.
    Other Names:
  • Cytoxan
  • Neosar
  • Drug: Rituximab
    375 mg/m^2 IV once weekly x 4 weeks.
    Other Names:
  • Rituxan
  • Outcome Measures

    Primary Outcome Measures

    1. Response Rate [two months]

      Response defined as at least 50% reduction of monoclonal IgM synthesis for at least two months with more than 50% reduction of tumor infiltrates at all involved sites (bone marrow, lymph nodes, spleen etc.). Complete response defined as disappearance of abnormal protein by immunofixation, resolution of lymphadenopathy and splenomegaly, less than 20% lymphocytes in bone marrow and no evidence of monoclonal lymphocytes.

    Secondary Outcome Measures

    1. After these drugs are given for 2 courses, a second goal is to see how long a remission lasts. [10 Years]

    2. A third goal is to see how often repeat remissions can be achieved when the lymphoma returns later and the same drugs are restarted. [10 Years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Newly diagnosed patients with symptomatic macroglobulinemic lymphoma are eligible. Macroglobulinemic lymphoma includes patients with either biopsy proven small lymphocytic lymphoma or chronic lymphocytic leukemia and monoclonal IgM. Also included are symptomatic patients with clonal proliferation producing a pathologic monoclonal IgM that causes cryoglobulinemia, peripheral neuropathy or cold agglutinin hemolytic anemia.

    2. Patients must have adequate liver function (bilirubin <2.5 mg%) and renal function (creatinine <2.0 mg%).

    Exclusion Criteria:

    None.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Texas MD Anderson Cancer CenterHoustonTexasUnited States77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Donna M. Weber, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00667329
    Other Study ID Numbers:
    • DM99-070
    • NCI-2020-00334
    First Posted:
    Apr 28, 2008
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 7, 2022