Completed

Autologous and Allogeneic Bone Marrow Transplantation for Low Grade Lymphoma

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What is being tested

Recombinant Interferon Alfa

+ Cyclophosphamide

+ Etoposide

BiologicalDrugProcedureRadiation
Who is being recruted

Blood Protein Disorders+26

+ Cardiovascular Diseases

+ Chronic Disease

From 15 to 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 1994
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: July 30, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1994

Actual date on which the first participant was enrolled.

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.

NCT00002829
Principal SponsorM.D. Anderson Cancer Center
Last updated: July 30, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 15 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesChronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesLeukemia, B-CellLymphoma, B-CellHemostatic DisordersDisease AttributesNeoplasms, Plasma CellLymphomaLymphoma, FollicularWaldenstrom MacroglobulinemiaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal Zone

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Texas - MD Anderson Cancer Center

Houston, United StatesOpen University of Texas - MD Anderson Cancer Center in Google Maps
CompletedOne Study Center