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Acalabrutinib for GVHD Prophylaxis in Allogeneic Hematopoietic Stem Cell Transplantation in Lymphomas and Leukemia

NCT04961801 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-03-08

No results posted yet for this study

Summary

GVHD remains a major cause of morbidity and mortality following SCT. The current standard of care for prophylaxis against GVHD includes tacrolimus and methotrexate.

This study proposes to utilize acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, for GVHD prophylaxis following allogeneic SCT.

The hypothesis is that the addition of acalabrutinib to our institutional standard GVHD prophylaxis (tacrolimus and methotrexate) is safe, feasible, and effective in reducing both the incidence and severity of acute GVHD.

Conditions

Interventions

DRUG

Acalabrutinib, tacrolimus, methotrexate

For Graft-Versus-Host Disease Prophylaxis in Allogeneic Hematopoietic Stem Cell Transplantation in Lymphomas and Leukemia

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    collaborator OTHER

  • Shin Mineishi

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2026-01-31
Completion
2030-01-31
FDA Drug
Yes

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Entities

Diseases

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 NCT04961801 on ClinicalTrials.gov