Treatment of Macroglobulinemic Lymphoma With 2CdA, Cyclophosphamide and Rituximab

NCT00667329 | Completed Phase 1 FDA Drug

• 2 other identifiers: DM99-070NCI-2020-00334
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response Rate

  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.

  two months

Secondary Outcomes (2)

• After these drugs are given for 2 courses, a second goal is to see how long a remission lasts.

  10 Years

• 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

Study Arms (1)

2CdA + Cyclophosphamide + Rituximab

EXPERIMENTAL

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; Drug: Cyclophosphamide; Drug: Rituximab

Interventions

2CdA DRUG

1.5 mg/m\^2 subcutaneous injection three times daily x 7 days.

Also known as: Leustatin, Cladribine

2CdA + Cyclophosphamide + Rituximab

Cyclophosphamide DRUG

40 mg/m\^2 PO twice daily x 7 days.

Also known as: Cytoxan, Neosar

2CdA + Cyclophosphamide + Rituximab

Rituximab DRUG

375 mg/m\^2 IV once weekly x 4 weeks.

Also known as: Rituxan

2CdA + Cyclophosphamide + Rituximab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma; Waldenstrom Macroglobulinemia

Interventions

Cladribine; Cyclophosphamide; Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Donna M. Weber, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: July 9, 1999
• Primary Completion: February 10, 2022
• Study Completion: February 10, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-03

Locations

US (1)