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Recruiting NCT04237623

GM-CSF With Post-Transplant Cyclophosphamide

Phase II Interventional Transplant-Related Hematologic Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sargramostim, Control Arm.
Who it may be relevant to
Registry conditions: Transplant-Related Hematologic Malignancy. Basic parameters: 18 years — 78 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Drug Sargramostim
    250mcg/m2/day IV starting Day +5
  • Other Control Arm
    Standard G-CSF given to those who decline to receive GM-CSF

Primary outcome measures

  • The number of patients who achieved neutrophil engraftment at 20 days after the initiation of treatment. [Time frame: 3 months after initial treatment]
Secondary outcome measures (9)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Northside Hospital — Atlanta

Identifiers

NCT: NCT04237623 · NSH 1246

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗