GM-CSF With Post-Transplant Cyclophosphamide

Conditions

• Transplant-Related Hematologic Malignancy

Eligibility Criteria

Sex

ALL

Age

18 Years - 78 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

May 18, 2020

Status verified

Apr 2026

Primary completion

Sep 18, 2026

Completion

Sep 18, 2026

Study Design

Enrollment

38 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• 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.

Primary Outcome Measure

The number of patients who achieved neutrophil engraftment at 20 days after the initiation of treatment. [ Time Frame: 3 months after initial treatment ]

Central Contacts

• Stacey Brown, BA
  404-780-7965
  [email protected]

Locations (1)

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