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Sargramostim for Blood Cancer

Phase 2
Recruiting
Led By Melhem Solh, MD
Research Sponsored by Northside Hospital, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
KPS >/= 70%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following initiation of treatment
Awards & highlights

Study Summary

This trial suggests that GM-CSF may be a better post-transplant treatment than G-CSF, with the potential to lower the risk of infection.

Who is the study for?
This trial is for patients with various blood cancers who need a stem cell transplant and have a partially matched related donor. They must be in good physical shape (KPS >/= 70%) and able to consent. It's not for those with poor heart, lung, liver, or kidney function, HIV-positive individuals, or anyone allergic to GM-CSF or yeast products.Check my eligibility
What is being tested?
The study tests if GM-CSF can help recover blood counts after a haploidentical stem cell transplant with post-transplant cyclophosphamide treatment while reducing infection risks compared to the standard G-CSF approach.See study design
What are the potential side effects?
Possible side effects of GM-CSF include bone pain, muscle aches, fever-like symptoms such as chills and fatigue; it may also cause injection site reactions and potentially affect blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a blood disorder that qualifies for a bone marrow transplant.
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I am mostly able to care for myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months following initiation of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following initiation of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of patients who achieved neutrophil engraftment at 20 days after the initiation of treatment.
Secondary outcome measures
How many patients are still alive measured by overall survival at 12 months following the 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
How many patients died due to a treatment-related adverse events grade 2 or greater as assessed by CTCAE v.4.0
+6 more

Side effects data

From 2021 Phase 4 trial • 87 Patients • NCT04326920
22%
Infectious disorder (not COVID-19)
15%
Constipation
7%
Cardiac disorder
5%
Epistaxis
2%
Pneumonia
2%
Thormboembolic event
2%
Aspergillus infection
2%
Respiratory failure
2%
Hypoxia
2%
Multi-bacterial bacteremia causing hemorrhagic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Active Sargramostim Treatment Group

Trial Design

1Treatment groups
Experimental Treatment
Group I: GM-CSF post-transplantExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
2008
Completed Phase 4
~850

Find a Location

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor
24 Previous Clinical Trials
1,053 Total Patients Enrolled
Melhem Solh, MDPrincipal InvestigatorNorthside Hospital
3 Previous Clinical Trials
65 Total Patients Enrolled

Media Library

Sargramostim Clinical Trial Eligibility Overview. Trial Name: NCT04237623 — Phase 2
Blood Cancers Research Study Groups: GM-CSF post-transplant
Blood Cancers Clinical Trial 2023: Sargramostim Highlights & Side Effects. Trial Name: NCT04237623 — Phase 2
Sargramostim 2023 Treatment Timeline for Medical Study. Trial Name: NCT04237623 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What situations is Sargramostim most frequently employed to manage?

"Sargramostim is traditionally used to treat serious infections, but it has also been useful in the treatment of lymphoma, Hodgkin's disease, bone marrow transplantation and forms of leukemia."

Answered by AI

Are there any significant risks associated with Sargramostim administration?

"Our team has assessed sargramostim's safety to be a 2, as the clinical data is only indicative of its security, not efficacy."

Answered by AI

How many participants are included in this trial?

"Affirmative. Information listed on clinicaltrials.gov indicates that this medical investigation, first published on May 18th 2020, is currently recruiting patients. 38 participants are needed from 1 centre across the country."

Answered by AI

Is the trial currently taking on new participants?

"Affirmative, the information on clinicaltrials.gov displays that this experiment is actively seeking candidates. This trial was initially published on May 18th 2020 and updated most recently on October 19th 2022. 38 participants are required from 1 centre for enrolment in this study."

Answered by AI

Are elderly individuals eligible to participate in this clinical experiment?

"This medical experiment is open to patients with an age range of 18-78 years."

Answered by AI

Is it possible to become a participant in this research endeavor?

"In order to qualify for this clinical trial, applicants must have a hematologic neoplasm and be between 18-78 years of age. The research team is hoping to recruit 38 people total."

Answered by AI

Are there any precedent research projects involving Sargramostim?

"At the moment, 43 clinical trials are being conducted for Sargramostim. Five of these experiments have entered Phase 3. The lion's share of studies related to this drug take place in Seattle, Washington yet there are 1888 distinct sites conducting research into its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
GM-CSF With Post-Transplant Cyclophosphamide
2020. "GM-CSF With Post-Transplant Cyclophosphamide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04237623.
~3 spots leftby Sep 2024
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