A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01384513

A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

PRIMARY OBJECTIVES:

I. To compare the overall survival (OS) rate at 2 years post treatment using the Jefferson 2 step reduced intensity conditioning (RIC) approach in patients with haploidentical family donors with hematological malignancies in morphological or radiographic remission or with chemosensitive, indolent diseases to historical OS rates in similar populations after RIC matched donor HSCT as reported in the literature.

SECONDARY OBJECTIVES:

I. To compare the treatment-related mortality (TRM) rate at 2 years for patients treated on this study to the historical TRM rates of patients undergoing RIC matched-sibling HSCT as reported in the literature.

II. To compare the 2 year relapse rates and relapse related mortality of patients with myeloid diseases to that of patients with lymphoid diseases who are treated on this Thomas Jefferson University (TJU) RIC 2 step approach.

III. To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treated on the TJU RIC 2 step approach.

IV. To evaluate engraftment rates and lymphoid reconstitution in patients treated on the TJU RIC 2 step approach.

V. To evaluate the incidence of TRM at 100 days in patients treated on the TJU RIC 2 step approach.

OUTLINE:

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -11 to -8 and bulsufan IV over 3 hours on days -10 to -9. Patients undergo total body irradiation (TBI) on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2.

TRANSPLANTATION: Patients undergo donor lymphocyte infusion (DLI) on day -6 and cluster of differentiation (CD)-34+ allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0.

GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or orally (PO) with taper beginning on day 42. Patients also receive mycophenolate mofetil IV twice daily (BID) on days -1 to 28.

After completion of study treatment, patients are followed up periodically for 2 years.

Status: 
Recruiting
Study Date: 
Mon, 06/27/2011 to Mon, 08/01/2016
Bone Marrow Disease(s): 
aplastic anemia
Intervention: 
Drug: Fludarabine Given IV Other Names: fludarabine phosphate Fludara Drug: Busulfan Given IV Other Names: Myleran Busulfex IV Radiation: Total Body Irradiation (TBI) 2 Gy administered as part of the conditioning regimen Other Name: radiotherapy Biological: Donor Lymphocyte Infusion (DLI) Undergo DLI Other Name: buffy coat fusion Drug: Cyclophosphamide (CY) Given IV Other Names: Endoxan Cytoxan Neosar Procytox Revimmune cytophosphane Drug: Tacrolimus Given IV or PO Other Names: FK-506 Fujimycin Drug: Mycophenolate mofetil Given IV Other Names: MMF CellCept Device: Allogeneic hematopoietic stem cell transplantation Undergo CD34+ allogeneic PBSCT Other Name: CliniMACS Procedure: Peripheral blood stem cell transplantation (PBSCT) Undergo CD34+ allogeneic PBSCT Other Names: PBPC transplantation PBSC transplantation peripheral blood progenitor cell transplantation transplantation peripheral blood stem cell