GM-CSF With Post-Transplant Cyclophosphamide

Description

Given the increased number of HLA-mismatched haploidentical transplantation with post-transplant cyclophosphamide performed each year and the high risk of infectious complications associated with this type of transplant, the investigators suggest that GM-CSF administration post-infusion of T-replete haploidentical stem cells and post-transplant cyclophosphamide can yield similar count recovery rates to G-CSF with a potential of lowering risk of infectious complications.

Conditions

Transplant-Related Hematologic Malignancy

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Study Overview

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Study Details

Study overview

Given the increased number of HLA-mismatched haploidentical transplantation with post-transplant cyclophosphamide performed each year and the high risk of infectious complications associated with this type of transplant, the investigators suggest that GM-CSF administration post-infusion of T-replete haploidentical stem cells and post-transplant cyclophosphamide can yield similar count recovery rates to G-CSF with a potential of lowering risk of infectious complications.

Phase II Trial Evaluating the Efficacy and Safety of Sargramostim Post-Infusion of T-Replete HLA Mismatched Peripheral Blood Haploidentical Hematopoietic Stem Cells and With Post Transplant Cyclophosphamide

GM-CSF With Post-Transplant Cyclophosphamide

Condition
Transplant-Related Hematologic Malignancy
Intervention / Treatment

-

Contacts and Locations

Atlanta

Northside Hospital, Atlanta, Georgia, United States, 30342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Availability of 5/10 to 8/10 matched related donor
  • * KPS \>/= 70%
  • * CML, AML, MDS, ALL, CLL, HD, NHL, MPS/CMML, MM, any other hematologic condition deemed an eligible indication for allogeneic transplant by the treating center
  • * Poor cardiac, pulmonary, liver, and renal function
  • * HIV-positive
  • * Patients who have a debilitating medical or psychiatric illness that would preclude them from giving informed consent
  • * History of severe or serious allergic reaction to human GM-CSF or yeast-derived products

Ages Eligible for Study

18 Years to 78 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northside Hospital, Inc.,

Melhem Solh, MD, PRINCIPAL_INVESTIGATOR, Northside Hospital

Study Record Dates

2025-09-18