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

  • STATUS
    Recruiting
  • End date
    Aug 26, 2023
  • participants needed
    70
  • sponsor
    Weill Medical College of Cornell University
Updated on 26 January 2021
remission
chronic myeloid leukemia
graft versus host disease
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
chronic lymphocytic leukemia
lymphoma
myelodysplastic syndromes
multiple myeloma
acute leukemia
myeloproliferative disorder
ejection fraction
melphalan
karnofsky performance status
blood disorder
leukemia
transplant conditioning
antithymocyte globulin
chronic lymphocytic leukemia, relapsed

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).

Description

This study is a prospective phase II non-inferiority study investigating tocilizumab as a potential alternative to anti-thymocyte globulin (ATG) in haplo-cord transplantation. It is a single-center study based at Weill Cornell Medicine/NewYork Presbyterian Hospital.

The hypothesis is that tocilizumab is a safe and effective alternative to ATG in haplo-cord transplantation, facilitating transient engraftment of the haplo-identical stem cell graft without prolonged neutropenia or second nadir prior to durable cord engraftment while also preventing graft versus host disease (GVHD).

This study plans to enroll patients with hematologic malignancies in need of alternate donor transplant. All subjects will be conditioned with fludarabine, melphalan and total body irradiation (TBI), followed by a single dose of tocilizumab 8 mg/kg on Day -1. Patients will be enrolled into 4 successive cohorts, initially administering the current standard 3 doses of ATG 1.5 mg/kg (total 4.5 mg/kg). In the absence of safety signals, we will drop one dose of ATG in successive cohorts until the drug ultimately has been eliminated.

The primary endpoint of the study is successful haplo-derived neutrophil engraftment. Treatment will only be of interest if there is evidence that this rate is greater than 60%. If there are 4 or fewer successes, that dose group will be deemed unacceptable and the next higher ATG dose for which there were 5 or more success will be expanded.

Details
Condition Hematologic Malignancy, Bone marrow transplant, Blood disorder, Blood Cancer, Hematologic Cancer, Hematological Disorders, Hematologic Neoplasms, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies, bone marrow transplantation, bone marrow graft
Treatment melphalan, Fludarabine, Tocilizumab, Total body irradiation, Anti-thymocyte globulin (rabbit)
Clinical Study IdentifierNCT04395222
SponsorWeill Medical College of Cornell University
Last Modified on26 January 2021

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