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

  • End date
    Jan 24, 2023
  • participants needed
  • sponsor
    Andrew Rezvani
Updated on 22 January 2022
graft versus host disease
myeloid leukemia
blast crisis
acute leukemia
granulocyte colony stimulating factor
myeloablative conditioning
gilbert's syndrome
transplant conditioning
blast cells
colony stimulating factor
acute biphenotypic leukemia


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.



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.


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.


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.

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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