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Trial record 1 of 39 for:    GM-CSF post transplant cyclophosphamide
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GM-CSF With Post-Transplant Cyclophosphamide

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ClinicalTrials.gov Identifier: NCT04237623
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : October 20, 2022
Sponsor:
Information provided by (Responsible Party):
Northside Hospital, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Transplant-Related Hematologic Malignancy Drug: Sargramostim Other: Control Arm Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : May 18, 2020
Estimated Primary Completion Date : May 18, 2024
Estimated Study Completion Date : May 18, 2025

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Sargramostim
250mcg/m2/day IV starting Day +5
Other Name: GM-CSF

Other: Control Arm
Standard G-CSF given to those who decline to receive GM-CSF
Other Name: G-CSF


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237623


Contacts
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Contact: Stacey Brown, BA 404-780-7965 stacey.brown@northside.com

Locations
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United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Stacey Brown, BA    404-780-7965    stacey.brown@northside.com   
Contact: Caitlin Guzowski, MBA, MHA    404-851-8523    caitlin.guzowski@northside.com   
Sub-Investigator: H. Kent Holland, MD         
Sub-Investigator: Asad Bashey, MD         
Sub-Investigator: Lawrence E Morris, MD         
Sub-Investigator: Scott Solomon, MD         
Principal Investigator: Melhem Solh, MD         
Sponsors and Collaborators
Northside Hospital, Inc.
Investigators
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Principal Investigator: Melhem Solh, MD Northside Hospital
More Information
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Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT04237623    
Other Study ID Numbers: NSH 1246
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: October 20, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases
 Sargramostim
Immunologic Factors
Physiological Effects of Drugs