NCT04237623

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
4mo left

Started May 2020

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
May 2020Sep 2026

First Submitted

Initial submission to the registry

January 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

May 18, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

January 17, 2020

Last Update Submit

April 15, 2026

Conditions

Transplant-Related Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

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

    3 months after initial treatment

Secondary Outcomes (9)

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

    12 months following initiation of treatment

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

    12 months following initiation of treatment

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

    12 months following initiation of treatment

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

    12 months following initiation of treatment

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

    12 months following initiation of treatment

  • +4 more secondary outcomes

Study Arms (1)

GM-CSF post-transplant

EXPERIMENTAL

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.

Drug: SargramostimOther: Control Arm

Interventions

Control ArmOTHER

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

Also known as: G-CSF
GM-CSF post-transplant
SargramostimDRUG

250mcg/m2/day IV starting Day +5

Also known as: GM-CSF
GM-CSF post-transplant

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

MeSH Terms

Interventions

sargramostimGranulocyte-Macrophage Colony-Stimulating FactorGranulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Melhem Solh, MD

    Northside Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacey Brown, BA

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 23, 2020

Study Start

May 18, 2020

Primary Completion (Estimated)

September 18, 2026

Study Completion (Estimated)

September 18, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)