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NCT Number: NCT04237623

GM-CSF With Post-Transplant Cyclophosphamide

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.

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Key information

Conditions

Transplant-Related Hematologic Malignancy

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location status: Recruiting

Location contact

Asad Bashey, MD

SUB_INVESTIGATOR

Caitlin Guzowski, MBA, MHA

CONTACT

[email protected]

404-851-8523

H. Kent Holland, MD

SUB_INVESTIGATOR

Lawrence E Morris, MD

SUB_INVESTIGATOR

Melhem Solh, MD

PRINCIPAL_INVESTIGATOR

Scott Solomon, MD

SUB_INVESTIGATOR

Stacey Brown, BA

CONTACT

[email protected]

404-780-7965

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sargramostim

Drug

250mcg/m2/day IV starting Day +5

Other names: GM-CSF

Control Arm

Other

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

Other names: G-CSF

Primary outcomes

  1. The number of patients who achieved neutrophil engraftment at 20 days after the initiation of treatment.

    Time frame: 3 months after initial treatment

    The aim of the study is to establish equivalent effectiveness of Sargramostim to a matched control cohort of G-CSF treated patients in time to achieve neutrophil (ANC >500 x3 days) post infusion of HLA-mismatched peripheral blood haploidentical stem cells with post-transplant cyclophosphamide. Patients will be followed for 3 months following the initiation of treatment to see engraftment numbers at 20 days after initial treatment.

Secondary outcomes

  1. How many patients are still alive measured by overall survival at 12 months following the initiation of treatment.

    Time frame: 12 months following initiation of treatment

    To estimate overall survival

  2. How many patients have not relapsed measured by relapse rates at 12 months following the initiation of treatment.

    Time frame: 12 months following initiation of treatment

    To estimate relapse rates

  3. How many patients develop graft-versus-host-disease (GVHD) measured by the incidence of GVHD at 12 months following initiation of treatment

    Time frame: 12 months following initiation of treatment

    To estimate incidence of GVHD

  4. How many patients have not relapsed measured by progression-free survival at 12 months following the initiation of treatment

    Time frame: 12 months following initiation of treatment

    To estimate non-relapse mortality

  5. How many patients died due to infections measured by the incidence and type of infections at 12 months following initiation of treatment

    Time frame: 12 months following initiation of treatment

    To estimate infection-related mortality

  6. How many patients died due to a treatment-related adverse events grade 2 or greater as assessed by CTCAE v.4.0

    Time frame: 12 months following initiation of treatment

    To estimate event-free survival

  7. Number of patients to achieve full donor chimerisms at Days 30, 50, 100, and 6 months post-transplant as measured by donor chimerism data

    Time frame: 12 months following initiation of treatment

    To estimate graft failure

  8. Number of patients that acquired an infection in the first 100-days post-transplant as measured by the incidence of infections

    Time frame: 12 months following initiation of treatment

    To estimate the rate of infections

  9. Number of patients achieving platelet engraftment as measured by platelets reaching 20,000 without transfusion for 7 days

    Time frame: 12 months following initiation of treatment

    To assess time to platelet engraftment

Study contacts

Contact information is provided by the study sponsor or research team.

Stacey Brown, BA

CONTACT

[email protected]

404-780-7965

Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2020
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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