Recruiting
Phase 2

GM-CSF with Cyclophosphamide

Sponsor:

Northside Hospital, Inc.

Code:

NCT04237623

Conditions

Transplant-Related Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Sargramostim

Control Arm

Study Details

Brief summary:

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

Study ID

NCT04237623

Start date

May 18, 2020

Status verified date

Apr, 2026

Completion date

Sep 18, 2026

Anticipated

Primary completion date

Sep 18, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: GM-CSF post-transplant

Sargramostim (GM-CSF) will start on Day +5 and continue until ANC >1000 x3 days or >1500 x1 day. GM-CSF will be administered not less than 24 hours after the last dose of cyclophosphamide and will be given at a dose of 250mcg/m2/day as an infusion over 2 hours.

Interventions

Sargramostim

250mcg/m2/day IV starting Day +5

Control Arm

Standard G-CSF given to those who decline to receive GM-CSF

Primary outcome measure

  • The number of patients who achieved neutrophil engraftment at 20 days after the initiation of treatment. [ Time Frame: 3 months after initial treatment ]

Central Contacts and Locations

Central contacts

Stacey Brown, BA

404-780-7965stacey.brown@northside.com

Locations

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Stacey Brown, BA

404-780-7965stacey.brown@northside.com

Caitlin Guzowski, MBA, MHA

404-851-8523caitlin.guzowski@northside.com

Principal Investigator:

Melhem Solh, MD

More Information

Sponsor

Northside Hospital, Inc.

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northside Hospital, Inc. on 2026-04-16.