RECRUITING

GM-CSF With Post-Transplant Cyclophosphamide

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-05-18
Study Completion:2025-09-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04237623

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.

Ages Eligible for Study:18 Years to 78 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Availability of 5/10 to 8/10 matched related donor
  2. * KPS \>/= 70%
  3. * 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
  1. * Poor cardiac, pulmonary, liver, and renal function
  2. * HIV-positive
  3. * Patients who have a debilitating medical or psychiatric illness that would preclude them from giving informed consent
  4. * History of severe or serious allergic reaction to human GM-CSF or yeast-derived products

Contacts and Locations

Study Contact

Stacey Brown, BA
CONTACT
404-780-7965
stacey.brown@northside.com

Principal Investigator

Melhem Solh, MD
PRINCIPAL_INVESTIGATOR
Northside Hospital

Study Locations (Sites)

Northside Hospital
Atlanta, Georgia, 30342
United States

Collaborators and Investigators

Sponsor: Northside Hospital, Inc.

  • Melhem Solh, MD, PRINCIPAL_INVESTIGATOR, Northside Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-05-18
Study Completion Date2025-09-18

Study Record Updates

Study Start Date2020-05-18
Study Completion Date2025-09-18

Terms related to this study

Additional Relevant MeSH Terms

  • Transplant-Related Hematologic Malignancy