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 range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Relapsed Leukemia

Timeframe: Up to 18 months

Trial details

NCT IDNCT03267186

SponsorAndrew Rezvani

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-30

Results submitted2023-05-11

View on ClinicalTrials.gov More Acute Biphenotypic Leukemia trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.