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Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation

NCT04395222 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-01-06

Study results available
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Summary

The purpose of this study is to evaluate the safety of reducing and ultimately eliminating anti-thymocyte globulin (ATG) from the haplo-cord transplant conditioning regimen and replacing it with tocilizumab, an IL-6 receptor monoclonal antibody, to improve immune reconstitution and reduce relapse while preserving low rates of graft failure and graft versus host disease (GVHD).

Conditions

  • Hematologic Malignancy
  • Bone Marrow Transplant

Interventions

DRUG

Tocilizumab

Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen

DRUG

Fludarabine

Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.

DRUG

Melphalan

Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.

DRUG

Anti-thymocyte globulin (rabbit)

Anti-thymocyte globulin (ATG) 1.5 mg/kg

RADIATION

Total Body Irradiation

Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Alexandra Gomez Arteaga, MD · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2022-09-28
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT04395222 on ClinicalTrials.gov