Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to help determine if palifermin and leuprolide acetate can help the immune system recover faster following a stem cell transplant. Blood stem cells are very young blood cells that grow in the body to become red or white blood cells or platelets. The transplant uses stem cells in the blood from another person. The donor can be a family member or a volunteer donor. This is called an allogeneic stem cell transplant.

The investigators want to see if palifermin and leuprolide acetate can help the immune system recover faster after an allogenic transplant because experiments have shown they may be able to do this.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Swedish Orphan Biovitrum
• Treatments: Cyclophosphamide; Leuprolide; Thiotepa

Criteria

Inclusion Criteria:

Treatment Portion:

• AML in 1st remission - for patients whose AML does not have "good risk" cytogenetic features (i.e. t (8;21), t(15;17), inv 16 without c-kit mutations).

• Acute leukemias of ambiguous lineage in ≥ 1st remission

• Secondary AML in remission

• AML in ≥ 2nd remission

• ALL in 1st remission with clinical or molecular features indicating a high risk for relapse; or ALL ≥ 2nd remission

• CML failing to respond to or not tolerating imatinib, dasatinib or nilotinib in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.

• Non-Hodgkins lymphoma with chemo responsive disease in any of the following categories:

intermediate or high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.

b.ii. any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant.

• Myelodysplastic syndrome (MDS): RA/RCMD with high risk cytogenetic features or transfusion dependence, RAEB-1 and RAEB-2

• Chronic myelomonocytic leukemia: CMML-1 and CMML-2.

• Patient's age is ≥18 or ≤60 years old

• Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status ≥ 70%

• Patients must have adequate organ function measured by:

Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 50% and must improve with exercise.

• Pulmonary: asymptomatic or if symptomatic, DLCO > 60% of predicted (corrected for hemoglobin)

• Hepatic: < 3xULN ALT and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia

• Renal: serum creatinine < 1.2 mg/dL or if serum creatinine is outside the normal range, the CrCl > 50 ml/min (measured or calculated/estimated)

• Patients have a plan to receive a CD34-selected peripheral blood stem cell transplant with TBI-based conditioning.

Exclusion Criteria:

• Active extramedullary disease

• Active and uncontrolled infection at time of transplantation

• Patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.

• Pregnant or breast feeding

• HIV infection

• Patient is felt to not be a candidate for TBI by the BMT service

Donor Inclusion Criteria:

• Donor must be willing and able to undergo PBSC collection.