Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab

Study Description

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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 disease	Intervention/treatment	Phase
Lymphoma	Drug: 2CdA; Drug: Cyclophosphamide; Drug: Rituximab	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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
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 :	July 1999
Estimated Primary Completion Date :	July 2019
Estimated Study Completion Date :	July 2019

Arms and Interventions

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Arm	Intervention/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 Name: Rituxan

Outcome Measures

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Primary Outcome Measures :

1. Response Rate [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 10 Years ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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:

Contacts and Locations

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Locations

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00667329 History of Changes
Other Study ID Numbers:	DM99-070; NCI-2010-01457 ( Registry Identifier: NCI CTRP )
First Posted:	April 28, 2008
Last Update Posted:	September 14, 2017
Last Verified:	September 2017

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:

Waldenstrom's Macroglobulinemia; Lymphoma; 2CdA; Cladribine; Leustatin	Cyclophosphamide; Cytoxan; Neosar; Rituxan; Rituximab

Additional relevant MeSH terms:

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cyclophosphamide; Cladribine; Rituximab; 2-chloro-3'-deoxyadenosine	Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Antimetabolites, Antineoplastic; Antimetabolites