Clinical trial NCT01871441
Conditions: Malignant Neoplasm
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Start date: 2013-05-17; Completion date: 2016-10-20
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well haploidentical donor hematopoietic stem cell transplant works in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor 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. Giving an infusion of the donor's T cells (donor lymphocyte infusion) may replace the patient's immune cells and help destroy any remaining cancer cells. When the stem cells from a related donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Detailed description:
PRIMARY OBJECTIVES:

I. Examine the 1 year disease free survival (DFS) rate of patients with maternal donors or sibling donors who share the maternal haplotype (maternal group) and compare them to patients receiving cells from donors who have points from other characteristics such as killer immunoglobulin-like receptor (KIR) ligand mismatching, minor histocompatibility antigen (MHag) differences, or number of human leukocyte antigen (HLA) mismatches (non-maternal group).

SECONDARY OBJECTIVES:

I. Assess the incidences of relapse and graft-versus-host disease (GVHD) in maternal recipients whose only eligible donors are offspring.

II. Assess the incidence of grades III-IV GVHD in female recipients with male donors.

III. Compare the rates of DFS in recipient-donor combinations in which there is at least 1 KIR ligand mismatch versus those without a KIR ligand mismatch.

OUTLINE:

Patients undergo total body irradiation (TBI) twice daily (BID) on days -9 to -6, undergo donor lymphocyte infusion (DLI) on day -6, and receive cyclophosphamide intravenously (IV) over 2 hours on days -3 and -2.

TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.

After completion of study treatment, patients are followed up at 90, 180, and 270 days, and 1 year.

Arms: arm 1: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.

TRANSPLANT: Patients undergo haploidentical allogeneic hematopoietic stem cell transplant on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42, and mycophenolate mofetil IV BID from day -1 to day 28.
Interventions: intervention 1: Total-body irradiation intervention 2: Donor lymphocytes infusion (DLI) intervention 3: Cyclophosphamide intervention 4: Allogeneic hematopoietic stem cell transplantation (HSCT) intervention 5: Tacrolimus intervention 6: Mycophenolate mofetil
Intervention descriptions: intervention 1: Undergo TBI intervention 2: Undergo DLI intervention 3: Given IV intervention 4: Undergo haploidentical allogeneic HSCT intervention 5: Given IV intervention 6: Given IV

Protocol documents: