Treatment of Non-Hodgkin Lymphoma with High-Dose Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) Followed by Allogeneic Marrow or Peripheral Blood Stem Cell Transplantation

Principal Investigator: Scott I. Bearman, MD

Protocol Number: RMBMT-126

Major Objectives

Patient Selection

Inclusion Criteria:

1. Be 18 years of age or older.
2. Have histologically proven non-Hodgkin’s Lymphoma (NHL) in one of the following categories:
   1. Low Grade Lymphoma – Stage III or IV chemo-sensitive at initial diagnosis or relapsed if chemo-sensitive
   2. Intermediate Grade Lymphoma – high-risk, chemo-sensitive lymphoma at initial diagnosis or relapse; high-risk is defined as those who have two or more unfavorable variables using the International Prognostic Index. Unfavorable variables include:
      1. ECOG Performance ≥ 2
      2. Ann Arbor Stage III-IV
      3. Elevated Serum LDH
   3. High Grade Lymphoma – initial diagnosis chemo-sensitive disease or relapsed chemo-sensitive disease
   4. Primary refractory NHL
   5. Mantle Cell Lymphoma – initial diagnosis chemo-sensitive disease or relapse, chemo-sensitive disease
   6. Be practicing effective birth control.
3. Have an ECOG performance status of 0 or 1 at the time of transplant with a life expectancy of at least 6 months.
4. Have major end organs (heart, lungs, liver, kidneys) assessed and deemed adequate to withstand the effects of high-dose therapy planned for this protocol. The method of assessment and determination of adequacy will be by site specific policies as on file with the overseeing IRB.
5. Have a HLA-matched or 1-antigen mismatched related donor.
6. Have given voluntary informed consent.

Exclusion Criteria:

1. Have a condition that makes them unacceptable for high-dose therapy.
2. Are female and are pregnant, lactating, or have a positive pregnancy test.
3. Have a history of previous malignancy except non-melanoma skin cancer and in-situ carcinoma of the cervix, unless the patient has been progression-free for >5years.
4. Are HIV positive.
5. Have MALT lymphoma.