New pill aims to stop High-Risk lymphoma relapse after cell treatment
NCT ID NCT05256641
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether the drug acalabrutinib, taken as a pill, can safely prevent relapse in people with very high-risk large B-cell lymphoma after they receive cell therapy (stem cell transplant or CAR T-cells). The trial will enroll 24 adults aged 18-70. Researchers will track how many patients stop the drug due to side effects and how long they stay cancer-free.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Acalabrutinib (a targeted cancer drug taken as a pill)
- What this could lead to
- If it works, this could help prevent lymphoma from coming back in patients who are at very high risk of relapse after cell therapy.
- What could go wrong
- This is an early-phase trial with only 24 people, so results may not apply to everyone. Acalabrutinib may cause side effects that lead some patients to stop taking it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ages 18-70 years * One of the following: * Patients undergoing autologous stem cell transplantation (ASCT) or any Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy product for: * High grade B-cell lymphoma (double or triple hit) with rearrangements in bcl-2 and/or bcl-6, and rearrangement in myc * Large B-cell lymphoma with a history of secondary CNS involvement * Histologic transformation of indolent lymphoma to large B-cell lymphoma, including marginal zone lymphoma, follicular lymphoma, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), lymphoplasmacytic leukemia, or Waldenstrom macroglobulinemia * High risk international prognostic index (IPI) score 4 or 5, at diagnosis or prior to CAR T-cell leukapheresis * Patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) for large B-cell lymphoma * Eastern Cooperative Oncology Group (ECOG) 0-2 * Requirements for post-ASCT and post-alloHCT participants: * Disease status of partial response (PR) or complete response (CR) prior to transplantation * Receive reduced-intensity conditioning regimen * Enrollment no later than day +90 * Requirements for post-CAR T-cell therapy participants: * Disease status of PR or CR after post-CAR T-cell therapy positron emission tomography (PET)-computed tomography (CT) at 1-3 months * Enrollment no later than day +104 * Ability to give full informed consent * Female subjects who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib * Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty * Absolute neutrophil count (ANC) \> 500/uL (microliters) * Platelets \> 50,000/uL independent of transfusions * Hemoglobin \> 8 g/dL independent of transfusions * Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN) * Total bilirubin =\< 1.5 x ULN, unless directly attributable to Gilbert's syndrome * Creatinine clearance \>= 60 mL/min based on Cockcroft-Gault glomerular filtration rate (GFR) and serum creatinine (Cr) =\< 1.8 mg/dL Exclusion Criteria: * Cord blood as donor source in alloHCT * New York Heart Association Class III or IV * Left ventricular ejection fraction \< 50% * Estimated glomerular filtration rate \< 30 mL/min * Concurrent long-term use of posaconazole or other strong CYP3A4 inhibitors and unable to replace with equivalent medication * Acute or chronic graft-versus-host disease (GvHD) \>= stage 3 at time of enrollment * Received packed red blood cells (pRBC) transfusion within the past 2 weeks * Received platelet transfusion within the past 1 week * Active invasive fungal infection * Active bacterial or viral infection until resolution of the infection * History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML) * Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug * Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug * Refractory nausea and vomiting, inability to swallow the formulated product, or malabsorption syndrome; chronic gastrointestinal disease, gastric restrictions, or bariatric surgery such as gastric bypass; partial or complete bowel obstruction, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment * Received a live virus vaccination within 28 days of first dose of study drug * Known history of infection with human immunodeficiency virus (HIV) * History of bleeding diathesis (e.g., hemophilia, von Willebrand disease) * Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists * Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor or inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited * Breastfeeding or pregnant * Concurrent participation in another therapeutic clinical trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UCLA / Jonsson Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90095, United States
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University of California Davis Comprehensive Cancer Center
RECRUITINGSacramento, California, 95817, United States
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University of Oklahoma
NOT_YET_RECRUITINGOklahoma City, Oklahoma, 73190, United States
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Other studies related to the condition(s) this trial covers.
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- A CAR-T therapy given by injection: can it help Hard-to-Treat lymphoma?
- New drug joins standard chemotherapy in fight against B-Cell lymphoma