Treatment of Non-Hodgkin Lymphoma with High-Dose Carmustine, Etoposide, Cytarabine, and Cyclophosphamide (BEAC) or Melphalan (BEAM) Followed by Autologous Peripheral Blood Progenitor Cells Standard Care Treatment Protocol

Protocol Number: RMBMT-07

Major Objectives

• BCNU 300mg/m²/day on day –7
• Etoposide 100mg/m² BID on days –6 through –3
• Ara-C 100mg/m² BID on days –6 through –3
• Cyclophosphamide 35mg/kg/day on days –6 through –3
• OR Melphalan 140mg/m² on day -2
• Reinfusion of Stem Cells on Day 0

• Mesna 500mg IV bolus 30 minutes prior to Cytoxan
• Mesna (35mg/kg)-500mg IV as continuous infusion daily for days-6 through –3
• Hydration with D51/2 NS with 20mEq KCL and 750mg MgSO4/L to run at 125cc/m²/hr will start 2 hours prior to first Cytoxan and continue 24 hours after completion of Cytoxan.
• Lasix 20mg IV 1 hour after completion of Cytoxan on Days –6 through –3.

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 (see Appendix I Working Formulation for staging/classification):
   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 Index. Unfavorable variables include:
      • ECOG Performance ≥ 2
      • Ann Arbor Stage III-IV
      • 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 (see Appendix I for REAL Classification definition)
3. Be practicing effective birth control.
4. Have an ECOG performance status of 0 or 1 with a life expectancy of at least 6 months.
5. Have major end organs (heart, lungs, liver, and 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.
6. Have an adequate number of hematopoietic stem cells for transplant collected by mobilization and apheresis (minimum of 2.0 X10⁶ CD 34+ cells/kg) or marrow harvesting (minimum of 1.0 X10⁶ CD 34+ cells/kg) and stored by cryopreservation.
7. 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.