GM-CSF With Post-Transplant Cyclophosphamide
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-78
SponsorNorthside Hospital, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Sargramostim
Drug250mcg/m2/day IV starting Day +5
Control Arm
Other interventionStandard G-CSF given to those who decline to receive GM-CSF
Treatment groups
38 Participants
are divided into 1 treatment groupGroup A: GM-CSF post-transplantExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
3 months after initial treatmentSecondary outcomes
1
How many patients are still alive measured by overall survival at 12 months following the initiation of treatment.
To estimate overall survival
Time frame
12 months following initiation of treatment2
How many patients have not relapsed measured by relapse rates at 12 months following the initiation of treatment.
To estimate relapse rates
Time frame
12 months following initiation of treatment3
How many patients develop graft-versus-host-disease (GVHD) measured by the incidence of GVHD at 12 months following initiation of treatment
To estimate incidence of GVHD
Time frame
12 months following initiation of treatment4
How many patients have not relapsed measured by progression-free survival at 12 months following the initiation of treatment
To estimate non-relapse mortality
Time frame
12 months following initiation of treatmentSponsors and contacts
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Source ClinicalTrials.gov