GM-CSF With Post-Transplant Cyclophosphamide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-18

Study Completion Date

2026-09-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Transplant-Related Hematologic Malignancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sargramostim

Intervention Type DRUG

250mcg/m2/day IV starting Day +5

Control Arm

Intervention Type OTHER

Standard G-CSF given to those who decline to receive GM-CSF

Interventions

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Sargramostim

250mcg/m2/day IV starting Day +5

Intervention Type DRUG

Control Arm

Standard G-CSF given to those who decline to receive GM-CSF

Intervention Type OTHER

Other Intervention Names

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GM-CSF G-CSF

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No