2-Step Approach to Stem Cell Transplant in Treating Participants With Hematological Malignancies

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

Official title: A 2 Step Approach to Matched Related Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies-5+5 Dosing

Status Active, not recruiting

Clinical Trial Summary

This phase II trial studies how well a 2-step approach to stem cell transplant works in treating patients with blood cancers. Giving chemotherapy and total body irradiation before a lymphocyte (white blood cell) and stem cell transplant helps stop the growth of cells in the bone marrow including normal blood-forming cells (stem cells) and cancer cells. By giving the donor cells in two steps, the dose of lymphocytes given can be tightly controlled and they can be made more tolerant to the body. When the healthy lymphocytes and 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 called graft versus host disease. Giving tacrolimus and mycophenolate mofetil may stop this from happening.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess whether providing a patient with "5+5" dosing in a 2 step matched related donor hematopoietic stem cell transplantation (HSCT) increases the percentage of patients who achieve full donor chimerism earlier as defined by 98% or greater donor T cell chimerism at 28 days post HSCT (d+28).

SECONDARY OBJECTIVES:

I. To assess day (d) +90 chimerism in patients receiving "5+5" dosing. II. To assess post HSCT relapse rates in patients receiving "5+5" dosing. III. To assess rates of grade II-IV graft versus host disease (GVHD) in patients receiving "5+5" dosing.

IV. To assess treatment-related mortality (TRM) in patients receiving "5+5" dosing.

EXPLORATORY OBJECTIVES:

I. To assess whether patients receiving "5+5" dosing have lower rates of cytomegalovirus (CMV) reactivation as compared to patients treated on Thomas Jefferson University (TJU) 08D.85 (1st Generation 2-Step Matched Related Trial).

OUTLINE:

CONDITIONING REGIMEN: Patients undergo total body irradiation (TBI) twice daily (BID) on days -9 to -6.

TRANSPLANT: Patients receive donor lymphocytes intravenously (IV) on day -6 after the last dose of TBI.

CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -3 and -2.

TRANSPLANT: Patients undergo hematopoietic stem cell transplantation on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Patients also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.

After completion of study treatment, patients are followed up at days 28, 90, 180, 270, and 365. ;

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm

• NCT number: NCT03712878
• Study type: Interventional
• Source: Thomas Jefferson University
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 19, 2018
• Completion date: September 19, 2024