This phase II trial studies how well palifermin with leuprolide acetate or degarelix works after total body-irradiation based donor stem cell transplant in treating patients with hematologic malignancies (cancer of the blood or bone marrow). Giving chemotherapy and total body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving palifermin and leuprolide acetate or degarelix and removing the T cells from the donor cells before transplant may stop this from happening. It is not yet known whether giving palifermin with leuprolide acetate or degarelix is more effective in helping the immune system recover faster after a donor stem cell transplant.
Additional locations may be listed on ClinicalTrials.gov for NCT01746849.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the percentage of patients who achieve a cluster of differentiation (CD)4+ T cell count of greater than 200 at 6 months as this endpoint has been associated with a decreased incidence of opportunistic infections (OIs).
SECONDARY OBJECTIVES:
I. Overall survival at 2 years.
II. Transplant related mortality at 6 months.
III. CD4+ T cell count at 12 months.
IV. Incidence of infections.
V. Relapse at 12 months.
VI. The incidence and severity of acute graft-versus-host disease (GVHD) at 100 days post allograft.
VII. Rates of non-engraftment.
VIII. Mucositis endpoints: grade, patient controlled anesthesia (PCA) use, total parenteral nutrition (TPN) use, length of transplant hospital stay (LOS).
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Beginning 2-6 weeks prior to pre-transplant conditioning regimen, patients receive leuprolide acetate intramuscularly (IM) and 3 months after the first dose. Patients receive palifermin intravenously (IV) on days -13 to -11 and 0-2, undergo total body irradiation (TBI) on days -9 to -6, and receive thiotepa IV over 2-4 hours on days -5 to -4, cyclophosphamide IV over 30-60 minutes on days -3 to -2, and anti-thymocyte globulin infused over 12 hours on days -3 to -2. Patients then undergo T-cell depleted allogeneic hematopoietic stem cell transplant on day 0. Patients also receive filgrastim subcutaneously (SC) once daily (QD) from day 7 until absolute neutrophil count (ANC) is > 2000 for 3 consecutive days.
ARM II: Beginning 4-14 days prior to pre-transplant conditioning regimen, patients receive degarelix SC. Beginning 1 month after the initial loading dose, patients receive degarelix SC every 28 days for up to 5 maintenance doses. Patients receive palifermin IV on days -13 to -11 and 0-2, undergo TBI on days -9 to -6, and receive thiotepa IV over 2-4 hours on days -5 to -4, cyclophosphamide IV over 30-60 minutes on days -3 to -2, and anti-thymocyte globulin infused over 12 hours on days -3 to -2. Patients then undergo T-cell depleted allogeneic hematopoietic stem cell transplant on day 0. Patients also receive filgrastim SC QD from day 7 until ANC is > 2000 for 3 consecutive days.
After completion of study treatment, patients are followed up once or twice weekly for 3 months, then every 4-6 weeks for 3 months, and then every 3-6 months for 2 years.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMiguel-Angel Perales
