Fludarabine and Total Body Irradiation 800 Centigray (cGy) or 1125 cGy For Allogeneic Stem Cell Transplant Using Graft Versus Host Disease Prophylaxis With Post-Transplant Cyclophosphamide and Tacrolimus, Without Mycophenolate Mofetil

Phase 2Active Not RecruitingNCT05256537

Ronald Paquette60 enrolled

Overview

This is a pilot study to evaluate the feasibility, safety and potential benefits of removing one immune suppressive drug called mycophenolate mofetil (MMF) from the standard allogenic stem cell transplant treatment protocol. MMF will be omitted from the transplant regimen in 60 eligible patients with hematologic malignancies. Participants will be followed for up to 2 years post standard of care transplant at Cedars-Sinai.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hematologic Neoplasms

Interventions

Omission of the drug mycophenolate mofetil

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient age 18-75 years * Patient has a related donor who is at least Human Leukocyte Antigen (HLA) haploidentical, or an unrelated donor who is a most a single HLA antigen mismatch. * Patient signs the Informed Consent Form for the study * Patient has a hematologic malignancy other than myelofibrosis and meets standard criteria for allogeneic stem cell transplant. * Patient is deemed suitable to receive Fludarabine and Total Body Irradiation (Flu/TBI) 1125 or Flu/TBI 800 conditioning regimen as standard of care transplant * Donor is willing to donate peripheral blood stem cells Exclusion Criteria: * Patient has a diagnosis of myelofibrosis * Patient has high titer antibodies against one or more donor HLA antigens * Patient has undergone prior autologous or allogeneic stem cell transplant. * Inability to collect sufficient peripheral blood stem cells from the donor

Outcomes

Primary Outcomes

Engraftment failure

Evaluate the feasibility of eliminating the drug Mycophenolate Mofetil (MMF) from the transplant regimens as determined by an acceptable rate of engraftment failure (\<10%). Engraftment failure is when the blood-forming cells received on transplant day do not start to grow and make healthy blood cells.

Time frame: 60 days post-transplant

Secondary Outcomes

Time to neutrophil and platelet engraftment

Days to neutrophil and platelet engraftment since transplant.

Time frame: 60 days post-transplant

Rate of severe acute GVHD by day +100.

Proportion of patients with severe acute GVHD at day 100 post-transplantation. * Acute GVHD is when the donated stem cells attack the body within the first 100 days post-transplant. * The modified Keystone criteria will be used for acute GVHD staging and grading.

Time frame: 100 days post-transplant

Treatment-related mortality

Rate of treatment-related mortality

Time frame: 5 days post- transplant to 2-years

Rate of severe chronic GVHD at 1 year

Proportion of patients with severe chronic GVHD at day 365 post-transplantation. -Chronic GVHD is when the donated stem cells attack the body after 100 days post-transplant. Chronic GVHD is defined by NIH Consensus Criteria for chronic GVHD.

Time frame: 1-year post-transplant

Relapse

Relapse rate at 1 and 2 years

Time frame: 1 year post-transplant and 2 years post-transplant

Overall Survival (OS)

Overall survival at 1 and 2 years

Time frame: 1-year post-transplant and 2-years post-transplant

Graft Versus Host Disease (GVHD)-free, Relapse Free Survival

Rate of GVHD-free, Relapse Free Survival

Time frame: 1-year post- transplant and 2-years post-transplant