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Diffuse Large B-cell LymphomaPhase 1NCT03939182

Abexinostat and Ibrutinib in Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma

A Phase 1 study testing Abexinostat and Ibrutinib in people with Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the safety of abexinostat at different doses to find out if it can work with ibrutinib to stop the cancer from growing. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Abexinostat and Ibrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
7 sitesUnited States
Study dates
29 May 2019to 22 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is ≥ 18 years of age at the time of signing Informed Consent
  • Patient is able and willing to adhere to the study visit schedule and other protocol requirements
  • Patient has histologically confirmed diagnosis of R/R mantle cell lymphoma or diffuse large B cell lymphoma
  • Diffuse large B cell lymphoma patients must have received at least 1 prior regimen and received, declined, or is ineligible for autologous or allogeneic stem cell transplant.
  • Diffuse large B cell lymphoma patients must have non-germinal center subtype disease applying the Hans classification algorithm using immunohistochemistry markers CD10, BCL6, and MUM1 (8).
  • Mantle cell lymphoma patients must have received at least 1 line of therapy
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  • Allogeneic stem cell transplant recipients be greater than 6 months post transplant, not on immunosuppression for prevention of graft versus host disease for >3 months and without active graft versus host disease
  • Autologous stem cell transplant recipients must have adequate bone marrow recovery and are transfusion independent
  • Patients with transformed DLBCL from an antecedent or simultaneous indolent B-cell Non-Hodgkin lymphoma are permitted.
  • Patient has at least one measurable lesion (≥ 1.5 cm) according to RECIL
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Patient has adequate bone marrow and organ function by:
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L independent of growth factor support
  • Platelets ≥100 x 10^9/L independent of transfusion
  • °For patients with documented bone marrow involvement of underlying MCL or DLBCL at time of study enrollment, platelets must be ≥75 x 10^9/L independent of transfusion
  • Hemoglobin (Hgb) ≥ 9.0 g/dL
  • °For patients with documented bone marrow involvement of underlying MCL or DLBCL at time of study enrollment, Hgb must be ≥ 8.0 g/dL
  • International Normalized Ratio (INR) ≤ 1.5
  • Creatinine clearance > 25 mL/min as determined by the Cockcroft-Gault equation or a 24-hour urine collection
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ ULN (or ≤3 x ULN if liver involved with disease Total serum bilirubin ≤ 1.5 ULN unless bilirubin rise is due to Gilbert"s syndrome or of non-hepatic origin
  • Normal serum potassium level with or without supplementation.
  • Left Ventricular Ejection Fraction (LVEF) ≥ 50%
  • Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trial. For females, these restrictions apply for 30 days month after the last dose of study drug. For males, these restrictions apply for 120 days after the last dose of study drug. Refer to section 9.7 "Reproductive toxicity" for additional details
  • Women of childbearing potential must have a negative urine pregnancy test at Screening and within 7 days of treatment initiation
  • Men must agree to not donate sperm during and 12 months after the study. Women should not donate ova/ooctyes for the purposes of
  • Patient is able to swallow and retain oral medications

Who cannot join

  • Patients previously treated with ibrutinib or HDAC inhibitor
  • Patient has a history of non-compliance to medical regimen or inability to grant consent
  • Patient is concurrently using other approved or investigational antineoplastic agent
  • Patient has not recovered to Grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
  • Patient has had major surgery or a wound that has not fully healed within 4 weeks of starting study drugs.
  • Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study
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  • Patient has evidence of active graft versus host disease (GVHD)
  • Patient has active central nervous system (CNS) disease or meningeal involvement.
  • Patient has history of stroke or intracranial hemorrhage ≤ 6 months from starting study drugs.
  • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Patient has clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification, Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO), unstable angina pectoris, symptomatic pericarditis, QTcF > 480 msec on the screening ECG (using the QTcF formula), or history of congenital long QT syndrome.
  • Patient has a concurrent active malignancy.
  • Malignancies treated with a curative intent with an expected life expectancy ≥ 5 years or a non-competing life expectancy risk are eligible (i.e. adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer, early stage breast cancer, treated prostate cancer or any other cancer from which the patient has been disease free for ≥ 3 years).
  • Patient with known history of human immunodeficiency virus (HIV), or any uncontrolled active systemic infection.
  • Patients with acute viral hepatitis or a history of chronic or active HBV or HCV infection.
  • Hepatisis B surface antigen and core antibody testing are required at screening. If Hepatisis B surface antigen is positive then HBV PCR is required and if positive, then patient will be excluded.
  • Hepatisis C antibody testing is required at screening. If positive, Hepatisis C PCR is required and if positive, pHepatisis C PCR is required and if positive, then patient will be excluded.
  • Patient has hepatic failure (Child-Pugh Class C)
  • Patient is currently receiving increasing or chronic treatment (> 10 days) with corticosteroids or another immunosuppressive agent. Patients requiring chronic therapy with steroids may take no more than 10mg daily of prednisone or equivalent.
  • Patient requires chronic treatment with a strong cytochrome P450 (CYP) 3A4 inhibitors, and inducers, or drugs known to induce Torsades de Pointes and the treatment cannot be discontinued or switched to a different medication prior to starting study drug (Appendix 1 and 3).
  • Patients with known bleeding diathesis (e.g. von Willebrand "s disease) or hemophilia
  • Patient is currently receiving warfarin or other Vitamin K antagonist. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed. Refer to Section 9.5 for Concomitant medication
  • Vaccinated with live, attenuated vaccines within 4 weeks of randomization
  • Patients with any life-threatening illness, medical condition or organ system dysfunction that in the opinion of the investigator could compromise the subject"s safety, interfere with absorption of metabolism of study drugs or put the study outcomes at undue risk.
  • Women who are pregnant or breastfeeding.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Rockville Centre

    Rockville Centre, New York, 11570

Other trials in United States

About this study

Official title: Phase I Study of Abexinostat and Ibrutinib in Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma

The purpose of this study is to test the safety of abexinostat at different doses to find out if it can work with ibrutinib to stop the cancer from growing.

Being tested
Abexinostat, Ibrutinib
Keywords
Abexinostat, Ibrutinib, 19-080
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbexinostatDrug

    Two doses of the abexinostat will be tested: 30 mg/m2 and 45 mg/m2 orally twice daily, 7 days/week given every other week during a 28-day cycle.

  • IbrutinibDrug

    Ibrutinib will be given at the FDA-approved dose for mantle cell lymphoma (MCL) of 560 mg orally daily for 28 day cycle.

Study groups in NCT03939182
Study groupRoleWhat they receive
Abexinostat and IbrutinibExperimentalThe investigational agents to be used in this study are ibrutinib and abexinostat. Ibrutinib will be administered once daily on a 28-day cycle. Abexinostat will be administered orally twice daily (approximately 4-6 hours apart) for 7 days a week given every other week on a 28-day cycle.
Receives: Drug: Abexinostat; Drug: Ibrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the MTD of abexinostat when combined with ibrutinib

    a standard 3+3 dose escalation scheme will be used. For any given dose an initial cohort of 3 patients will be treated at that dose. The dose level will be escalated if none of the 3 patients exhibits any DLT.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start29 May 2019
  3. Primary completion22 Apr 2025
  4. Study completion22 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a phase I with dose expansion, open label single institution trial. The first stage is a standard 3+3 dose escalation trial. In the second stage, the dose expansion cohort will accrue patients at the MTD abexinostat and ibrutinib previously determined.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03939182
Sponsor's protocol ID
19-080
Status last verified
Apr 2025
First submitted
3 May 2019
Last updated
25 Apr 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Abexinostat and Ibrutinib in people with Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the MTD of abexinostat when combined with ibrutinib (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03939182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.

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