Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant

  • STATUS
    Recruiting
  • End date
    Jan 24, 2023
  • participants needed
    50
  • sponsor
    Andrew Rezvani
Updated on 22 January 2022
sirolimus
graft versus host disease
myeloid leukemia
fludarabine
tacrolimus
blast crisis
busulfan
acute leukemia
methotrexate
filgrastim
granulocyte colony stimulating factor
melphalan
myeloablative conditioning
leukemia
gilbert's syndrome
transplant conditioning
blast cells
colony stimulating factor
acute biphenotypic leukemia

Summary

This phase II trial studies how well ibrutinib works in preventing acute leukemia in patients after reduced-intensity conditioning and stem cell transplant. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Description

PRIMARY OBJECTIVES:

I. To reduce the incidence of relapse at 18 months after reduced-intensity conditioning (RIC) and allogeneic hematopoietic cell transplantation (HCT) for acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and chronic myeloid leukemia (CML) in blast crisis from a historical baseline of 45% to 25%, using ibrutinib maintenance therapy.

SECONDARY OBJECTIVES:

I. To study the incidence and severity of post-transplant complications in subjects receiving ibrutinib maintenance after allogeneic HCT.

II. To study the incidence of infectious complications in subjects receiving maintenance ibrutinib after allogeneic HCT.

III. To study the impact of ibrutinib maintenance on minimal residual disease after RIC and allogeneic HCT.

IV. To study the impact of maintenance ibrutinib on immune reconstitution and alloreactivity after allogeneic HCT, specifically on Th1/ Th2 polarization, T follicular cell number, T and B cell repertoire, serum immunoglobulin levels, and alloantibody formation.

OUTLINE

Beginning 60-90 days after allogeneic HCT, patients receive ibrutinib orally (PO) once daily (QD) for up to 18 months post-transplant in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Details
Condition childhood ALL, Lymphocytic Leukemia, Acute, Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), Acute myeloid leukemia, Acute biphenotypic leukemia, Chronic myeloid leukemia, Chronic myeloid leukemia, Acute Myelogenous Leukemia (AML), Hematopoietic Cell Transplantation Recipient, Lymphocytic Leukemia, Acute, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, biphenotypic acute leukemia, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment laboratory biomarker analysis, Ibrutinib
Clinical Study IdentifierNCT03267186
SponsorAndrew Rezvani
Last Modified on22 January 2022

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