E1402 - A Phase II Study of Reduced Intensity (Nonmyeloablative) Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin and Hodgkin Lymphoma

Protocol Number: RMBMT-146

Major Objectives

• To evaluate the proportion of non-hodgkin or Hodgkin lymphoma patients (who relapsed after prior autologous hematopoietic stem cell transplant or who could not be mobilized for autologous stem cell transplant) who have stable engraftment of donor cells using a reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant for treatment of non-Hodgkin or Hodgkin Lymphoma.
• To assess the extent and duration of acute and chronic graft-versus-host-disease.
• To assess the 100-day overall survival and long-term disease-free survival.

Patient Selection

Inclusion Criteria:

1. Patients must have either non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) that has relapsed following a course of high-dose chemotherapy and autologous stem cell transplantation OR have failed to mobilize adequate stem cells to undergo autologous stem cell transplant. All subtypes of NHL or HD are eligible.
2. Patients must be ≥ 90 days from prior transplant
3. Patients must have a suitable HLA-matched related bone marrow donor or a compatible matched unrelated bone marrow donor by molecular typing at HLA A, B, C, DR
   • Related Donor may be sibling, parent or child: HLA 6/6 or 5/6
   • Unrelated donor must be 6/6
   • Umbilical Cord blood donor units may not be used
4. Patients must be physically and psychologically capable of undergoing bone marrow transplantation and its attendant period of strict isolation.
5. Patients must test negative for P21 antibodies to HIV because HIV+ patients tolerate transplants poorly.
6. Patients must have no evidence of active infection. Patient must not have received parenteral antibiotics ≤ 2 weeks prior to registration
7. Patients must be age ≥ 18 years.
8. Women of childbearing potential and sexually active males must be advised to use an accepted and effective method of contraception.
9. Female patient must not be pregnant or breast-feeding due to unknown effects to the fetus or child. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
10. Patients must have an ECOG performance status 0-2 at time of registration.
11. Patient must be able to receive 400cGy Total Body Irradiation (TBI)
12. Patients must have at least on measurable or evaluable disease parameter, assess ≤ 4 weeks prior to study entry. All areas of disease should be recorded at baseline so subsequent responses can be fully assessed.
13. Pulmonary Function tests: DLCO ≥ 50% predicted, FEV₁ ≥ 50% predicted. Must be complete ≤ 4 weeks prior to registration.
14. LVEF at least 45% by MUGA or echocardiogram. Must be completed ≤ 4 weeks prior to registration.
15. Renal function: Creatinine clearance > 50ml/min. Must be completed ≤ 4 weeks prior to registration.
16. Liver function tests: < 3 x ULN. Liver function test include SGOT (AST), SGPT (ALT) and bilirubin. Must be completed ≤ 4 weeks prior to registration.
17. Patients must not be curable with any other therapeutic interventions.
18. Patients with low grade lymphoma must have exhausted treatment options that would be expected to result in long-term survival or long term palliation.