Study on Tandem Stem Cell Transplantation for High-Risk Non-Hodgkin's Lymphoma

Inclusion Criteria

• Age 18 to 70 years.

• Histologically proven non-Hodgkin's lymphoma

• High risk disease including at least one of the following:

  • Relapsed or refractory disease
  • Transformed lymphoma
  • Aggressive T-cell lymphoma
  • Failure to achieve completed remission (CR) following Auto SCT
  • Less than a 20% chance of event-free survival from autologous transplant determined by the treating physician and the Principal Investigator

• ECOG performance status < or = 2

• Underwent Autologous SCT 60-120 days prior to registration including:

  • BEAM conditioning (BCNU: 300 mg/m2 IV day -7, Etoposide: 100 mg/m2 IV BID days -6,-5,-4,-3, Cytarabine: 100 mg/m2 IV BID days -6,-5,-4,-3, Melphalan: 140 mg/m2 IV day -2)
  • Minimum of 2 x 106 CD34+ cells/kg infused

• Full hematologic recovery following Auto HCT including:

  • Absolute neutrophil count (ANC) >1000 µl
  • Platelet count of ≥50,000 µl independent of transfusion for >7 days

• Available matched related or unrelated donor. Selected donor must be a complete match or have only a single antigen mismatch.

• Women of child-bearing potential and sexually active males must use an accepted and effective method of birth control.

• Bone marrow comprising of < 10% lymphoma on most recent biopsy/aspiration (within 9 months of Allo transplant; may have been performed prior to autologous transplant).

• Serum bilirubin < or = 2 x the institutional ULN

• Serum creatinine < or = 2 x the institutional ULN and measured or estimated creatinine clearance > 60 cc/min by the following formula

  • Estimated Creatinine Clearance = (140 age)X WT(kg) X 0.85 if female 72X serum creatinine(mg/dl).

• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria

• Prior autologous or allogeneic hematopoietic cell transplantation (other than autologous SCT 60-120 days prior to registration)
• Prior radioimmunotherapy
• Known or suspected progressive disease following autologous SCT
• Additional treatment for NHL administered from time of autologous SCT through registration
• Pregnant or breast-feeding women (due to the known birth defects association with the treatments used in this study)
• Human immunodeficiency virus (HIV)-positive (the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population.)
• Any prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years.
• Active infection requiring oral or intravenous antibiotics.

Inclusion of Women and Minorities

-Both men and women and members of all races and ethnic groups are eligible for this trial.