Active — Not RecruitingPhase 2

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

United States21 participantsStarted 2020-10-07

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subject must have a confirmed diagnosis of one of the following:
✓. Relapsed or refractory acute leukemia (myeloid or lymphoid)
✓. Acute leukemia in first remission at high-risk for recurrence
✓. Chronic myelogenous leukemia in chronic, accelerated phase or blast-crisis
✓. Myelodysplastic syndromes
✓. Chronic myeloproliferative disease
✓. Recurrent, refractory or high-risk malignant lymphoma
✓. Chronic lymphocytic leukemia, relapsed or with poor prognostic features

Exclusion criteria

✕. Life expectancy is severely limited by concomitant illness or uncontrolled infection.
✕. Evidence of chronic active hepatitis or cirrhosis
✕. Uncontrolled HIV disease.
✕. Pregnancy or lactation.
✕. History of complicated diverticulitis, including fistulae, abscess formation or gastrointestinal perforation
✕. History of allergic reactions attributed to compounds of similar chemical or biological composition as tocilizumab, including known allergies to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.

What they're measuring

Percentage of Subjects With Successful Haplo-derived Neutrophil Engraftment

Timeframe: 21 days post-transplant

Trial details

NCT IDNCT04395222

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-28

Results submitted2023-09-26

View on ClinicalTrials.gov More Hematologic Malignancy trials