Spots Global Cancer Trial Database for Study of Nonmyeloablative Peripheral Blood Stem Cell Transplant With High-dose Posttransplantation Cyclophosphamide in Hematopoietic Malignancies Including Those That Are Challenging to Engraft

Study Description

Brief Summary: This is an open label phase II single arm study of peripheral blood stem cell transplantation and posttransplantation cyclophosphamide, using HLA full match or haploidentical related donors, in hematological malignancies including those difficult to engraft. The objective of this study is to evaluate the safety and feasibility in nonmyeloablative, partially HLA-mismatched or HLA-matched PBSC transplant from haploidentical donors or fully matched donors with post-grafting immunosuppression that includes high-dose cyclophosphamide, tacrolimus, and Mycophenolate mofetil (MMF).

Detailed Description: Primary Objective Estimate event free survival (EFS) (relapse, progression, or death) rate one year after transplant. Secondary Objectives: 1. Estimate the cumulative incidences of severe acute grade III or higher GVHD, chronic GVHD (overall and by extent) 2. Estimate the cumulative incidence of systemic steroid initiation, 3. Summarize the graft failure frequency, 4. Summarize the kinetics of neutrophil and platelet recovery, and kinetics of donor chimerism in unsorted and CD3+ sorted peripheral blood. 5. Summarize major toxicities and complications associated with the transplantation procedure selected toxicities. Exploratory Objectives: Explore the association between the amount of donor T cell chimerism at \~ Day 28 and patient/graft characteristics (e.g., prior therapies, graft cell dose) and transplantation outcomes (sustained engraftment, relapse or progression, GVHD).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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