Sargramostim for Blood Cancers

Northside Hospital, Atlanta, GA
Blood CancersSargramostim - Drug
Eligibility
18 - 78
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Transplant-Related Blood Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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αβ-TCR/CD19 cell depleted haploidentical hematopoietic stem cell graft
1
TCRαβ+/CD19+ depleted Haploidentical HSCT

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 12 months following initiation of treatment

Month 12
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
How many patients died due to infections measured by the incidence and type of infections at 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
How many patients have not relapsed measured by relapse rates at 12 months following the initiation of treatment.
Number of patients achieving platelet engraftment as measured by platelets reaching 20,000 without transfusion for 7 days
Number of patients that acquired an infection in the first 100-days post-transplant as measured by the incidence of infections
Number of patients to achieve full donor chimerisms at Days 30, 50, 100, and 6 months post-transplant as measured by donor chimerism data
Month 3
The number of patients who achieved neutrophil engraftment at 20 days after the initiation of treatment.

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Single arm study
1
αβ-TCR/CD19 cell depleted haploidentical hematopoietic stem cell graft
1
TCRαβ+/CD19+ depleted Haploidentical HSCT

Side Effects for

Active Sargramostim Treatment Group
20%Epistaxis
18%Infectious disorder (not COVID-19)
8%Constipation
5%Acute kidney injury
5%Cardiac disorder
3%Persistent catatonic state and neurological deficits
3%Respiratory distress
3%Cerebrovascular accident
3%Invasive aspergillosis
3%Presyncope
3%Respiratory deterioration due to underlying MPO-ANCA vasculitis and aspergillosis
3%Ventilator associated pneumonia
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT04326920) in the Active Sargramostim Treatment Group ARM group. Side effects include: Epistaxis with 20%, Infectious disorder (not COVID-19) with 18%, Constipation with 8%, Acute kidney injury with 5%, Cardiac disorder with 5%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

GM-CSF post-transplant
1 of 1

Experimental Treatment

38 Total Participants · 1 Treatment Group

Primary Treatment: Sargramostim · No Placebo Group · Phase 2

GM-CSF post-transplantExperimental Group · 2 Interventions: Sargramostim, Control Arm · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months following initiation of treatment

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor
21 Previous Clinical Trials
768 Total Patients Enrolled
Melhem Solh, MDPrincipal InvestigatorNorthside Hospital
3 Previous Clinical Trials
65 Total Patients Enrolled

Eligibility Criteria

Age 18 - 78 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to have a family member who is a good match for a transplant (with a matching score of 5/10 to 8/10).
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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