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Autologous and Allogeneic Bone Marrow Transplantation for Low Grade Lymphoma

Phase 2
15 Years
60 Years
Not Enrolling

Thank you

Trial Information

Autologous and Allogeneic Bone Marrow Transplantation for Low Grade Lymphoma

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

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

Inclusion 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Response

Outcome Time Frame:

2 Years

Safety Issue:


Principal Investigator

Richard E. Champlin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 1994

Completion Date:

April 2002

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009