GM-CSF With Post-Transplant Cyclophosphamide

Northside Hospital, Inc.

Status and phase: Enrolling; Phase 2

Conditions: Transplant-Related Hematologic Malignancy

Treatments: Other: Control Arm; Drug: Sargramostim

Study type: Interventional

Funder types: Other

Identifiers

NCT04237623

NSH 1246

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

GM-CSF post-transplant

Experimental group

Description:

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.

Treatment:

Drug: Sargramostim

Other: Control Arm