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Bone Marrow Transplantation in Treating Patients With Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002829
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : July 30, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells, and may be an effective treatment for lymphoma. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with recurrent or residual low-grade lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: Recombinant Interferon Alfa Drug: Cyclophosphamide Drug: Etoposide Drug: Mesna Procedure: Bone Marrow Transplantation Radiation: Radiation Therapy Phase 2

Detailed Description:

OBJECTIVES: I. Examine the potential role of high dose etoposide, cyclophosphamide, total body irradiation and bone marrow transplantation for patients at high risk for disease progression. II. Determine the value of monitoring the quality of remission by PCR assessment of BCl-2. III. Evaluate the efficacy of alpha interferon for patients with evidence of residual or recurrent lymphoma. IV. Evaluate the efficacy of bone marrow purging by PCR assessment of BCl-2.

OUTLINE: Patients receive a brief 2-3 cycles of intensive chemotherapy to achieve minimum disease state. Etoposide is administered intravenously on day -8. Cyclophosphamide is infused intravenously over 2 hours daily on day -7 and -6. Patients receive mesna beginning 1 hour after initiation of the cyclophosphamide treatment. Total body irradiation is received on days -4, -3, -2 , and -1. On day 0 allogeneic or autologous bone marrow is infused intravenously. Patients with residual or recurrent lymphoma receive interferon alpha daily.

PROJECTED ACCRUAL: 35 allogeneic and 40 autologous patients are expected to be enrolled.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous and Allogeneic Bone Marrow Transplantation for Low Grade Lymphoma
Study Start Date : February 1994
Actual Primary Completion Date : April 2002
Actual Study Completion Date : April 2002

Arm Intervention/treatment
Experimental: Bone Marrow Transplantation Biological: Recombinant Interferon Alfa

Drug: Cyclophosphamide
Infused intravenously over 2 hours daily on Day -7 and -6.
Other Names:
  • Cytoxan
  • Neosar

Drug: Etoposide
Administered intravenously on Day -8
Other Name: VePesid

Drug: Mesna
Beginning 1 hour after initiation of the cyclophosphamide treatment.
Other Name: Mesnex

Procedure: Bone Marrow Transplantation
Infusion on Day 0.
Other Name: BMT

Radiation: Radiation Therapy
Total body irradiation is received on days -4, -3, -2 , and -1.
Other Names:
  • RT
  • Radiotherapy
  • TBI

Primary Outcome Measures :
  1. Number of Patients with Response [ Time Frame: 2 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven low grade lymphoma in the following settings: Consolidation of newly diagnosed stage IV high-risk patients after 6-9 months of intensive conventional dose chemotherapy involving doxorubicin High risk is defined as >=5 cm adenopathy and >=2 extranodal sites at diagnosis, or males with >=5 cm adenopathy and > 20% marrow infiltrate at diagnosis) Failure to achieve CR within 6 months in newly diagnosed patients with intensive doxorubicin treatment Relapse patients who are sensitive to doxorubicin or ESHAP chemotherapies Patients with resistant chemotherapy failure (allogeneic BMT only) Patients with HLA-identical sibling donors are eligible for allogeneic bone marrow transplantation; other patients are eligible for autologous marrow transplantation Bone marrow must be in complete or near complete remission (< 15 % malignant cells) in autologous transplant patients

PATIENT CHARACTERISTICS: Age: 15 to 60 years Performance Status: Zubrod 0-2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction at least 50% Pulmonary: DLCO at least 50% Other: No concomitant severe medical illnesses No psychosis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy Surgery: Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002829

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United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Study Chair: Richard E. Champlin, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00002829    
Other Study ID Numbers: DM94-009
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-DM-94009 ( Other Identifier: UT MDACC )
CDR0000065027 ( Registry Identifier: NCI PDQ )
First Posted: May 26, 2004    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012
Keywords provided by M.D. Anderson Cancer Center:
Waldenstrom macroglobulinemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma
mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antiviral Agents
Anti-Infective Agents