Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem … (NCT03267186) | Clinical Trial Compass
CompletedPhase 2
Ibrutinib in Preventing Acute Leukemia in Patients After Reduced-Intensity Conditioning and Stem Cell Transplant
United States8 participantsStarted 2017-09-12
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* INCLUSION CRITERIA FOR ENROLLMENT (PRE-TRANSPLANT)
* Diagnosis of acute myeloid leukemia (AML), acute biphenotypic leukemia, or acute lymphoblastic leukemia (ALL); CML transformed to blast crisis is eligible
* Planned allogeneic HCT using fludarabine phosphate (FLU)/melphalan hydrochloride (MEL) or FLU/busulfan (BU) conditioning
* Planned graft versus host disease (GVHD) prophylaxis consisting of tacrolimus (TAC)/methotrexate (MTX) or TAC/sirolimus (SRL)
* Human leukocyte antigen (HLA) identical sibling donor, HLA matched unrelated donor, or donor mismatched at 1 HLA allele or antigen
* Less than or equal to 5% blasts on bone marrow examination within 60 days of starting conditioning
* Age \>= 18 years and =\< 70 years
* Able to give informed consent
* Subjects will be eligible if their planned conditioning regimen for allogeneic HCT consists of one of the two following standard reduced intensity conditioning regimens:
* FLU/MEL: fludarabine phosphate (fludarabine) 120 to 180 mg/m\^2; melphalan hydrochloride (melphalan) =\< 150 mg/m\^2
* FLU/BU: fludarabine 120 to 180 mg/m\^2; busulfan =\< 8 mg/kg orally or =\< 6.4 mg/kg intravenously
* Subjects will be eligible if their planned post grafting immunosuppression consists of one of the two following regimens:
* TAC/MTX: tacrolimus (oral or intravenous) and intravenous methotrexate administered according to institutional standard practice.
* TAC/SRL: tacrolimus (oral or intravenous) and oral sirol…