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Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation

NCT03680092 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-10-02

Study results available
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Summary

The purpose of this study is to investigate whether the combination of cyclophosphamide and abatacept versus the treatment used in standard of care will reduce the incidence of moderate and severe chronic graft-versus-host disease (GVHD) following hematopoietic stem cell transplantation. GVHD occurs when the cells from your donor (the graft) see your body's cells (the host) as different and attack them.

Conditions

  • GVHD
  • Hematologic Neoplasms

Interventions

DRUG

Cyclophosphamide

Day 3 and day 4 following transplant. Dosing will be based on patients' actual weight up to 120% of ideal body weight, above which it will be based on adjusted ideal body weight (ideal weight plus 50% of the difference between ideal and actual weight).

DRUG

abatacept

Abatacept at a dose of 10mg/kg will be administered on days +5, +14 and +28, +56, +84, +112, +140, +168

DRUG

Methotrexate

standard of care Methotrexate 5 mg/m2 on Days 1, 3, 6 and 11

DRUG

Tacrolimus

Tacrolimus per institutional guidelines

Sponsors & Collaborators

Principal Investigators

  • Dimitrios Tzachanis, MD PhD · University of California, San Diego

  • Divya Koura, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-26
Primary Completion
2023-06-15
Completion
2023-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03680092 on ClinicalTrials.gov