Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies

Chronic Lymphocytic Leukemia Clinical Trial

Official title: A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Hematologic Malignancies

Status Completed

Clinical Trial Summary

This phase II trial studies reduced-intensity conditioning before donor stem cell transplant in treating patients with high-risk hematologic malignancies. Giving low-doses of 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. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) before the transplant may help increase this effect.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To compare the rate of disease-free survival (DFS) at 1 year post hematopoietic stem cell transplant (HSCT) in patients undergoing HSCT treated on this successor Thomas Jefferson University (TJU) 2 Step reduced intensity conditioning (RIC) haploidentical regimen and compare it with that of the initial 2 Step RIC regimen.

SECONDARY OBJECTIVES:

I. To assess the 100 day regimen-related mortality (RRM) in patients undergoing HSCT on this treatment protocol.

II. To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treatment on this regimen.

III. To evaluate engraftment rates and lymphoid reconstitution in patients treated on this trial.

IV. To assess overall survival at 1 and 3 years past HSCT in patients treated on this trial.

OUTLINE:

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) on days -15 to -12, busulfan IV on days -14 to -13, donor lymphocyte infusion (DLI) on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo total-body irradiation (TBI) on day -10.

TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV twice daily (BID) on days -1 to 28.

After completion of study treatment, patients are followed up periodically. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia With FLT3/ITD Mutation
• Acute Myeloid Leukemia With Gene Mutations
• Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM
• Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214
• Anemia, Aplastic
• Aplastic Anemia
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Chronic Myelomonocytic Leukemia
• Follicular Lymphoma
• Hematologic Neoplasms
• Hodgkin Lymphoma
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Myelofibrosis
• Myeloid Leukemia
• Non-Hodgkin Lymphoma
• Plasma Cell Myeloma
• Polycythemia
• Polycythemia Vera
• Recurrence
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Childhood Acute Myeloid Leukemia
• Refractory Acute Myeloid Leukemia
• Secondary Acute Myeloid Leukemia
• Therapy-Related Acute Myeloid Leukemia

• NCT number: NCT01760655
• Study type: Interventional
• Source: Thomas Jefferson University
• Status: Completed
• Phase: Phase 2
• Start date: December 24, 2012
• Completion date: December 5, 2022