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T-cell LymphomaPhase 1NCT05983965

Study of Tazemetostat in Lymphoid Malignancies

A Phase 1 study testing Tazemetostat in people with T-cell Lymphoma, run by University of Alabama at Birmingham at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Tazemetostat is an oral EZH2 inhibitor which has been FDA approved for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
T-cell Lymphoma
What is being tested?
Tazemetostat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
5 Sep 2024to 6 Mar 2026
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

  • Histologically confirmed peripheral T-cell lymphomas (PTCL) with allowed subtypes listed below as per the revised World Health Organization 2022 classification [6]:
  • PTCL subtypes allowed
  • PTCL-not otherwise specified (NOS)
  • Nodal T-follicular helper cell lymphoma - angioimmunoblastic type, follicular type, or NOS
  • Anaplastic Large Cell Lymphoma (ALK+)
  • Anaplastic Large Cell Lymphoma (ALK-)
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  • Enteropathy-associated T-cell lymphoma
  • Monomorphic epitheliotropic intestinal T-cell lymphoma
  • Hepatosplenic T-cell lymphoma
  • Subcutaneous panniculitis-like T-cell lymphoma
  • Adult T-cell leukemia / lymphoma - lymphomatous, acute, or unfavorable chronic subtypes
  • Patients must have relapsed or refractory disease.
  • Relapsed disease is defined when a patient progressed (>3 months) after achieving CR with a previous treatment
  • Refractory disease is defined when a patient failed to achieve a CR or PR after a previous treatment
  • Patients received at least 1 prior therapy for PTCL.
  • At least one bi-dimensionally measurable nodal lesion, defined as ≥ 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as ≥ 1.0 cm in its longest diameter on fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) scan as defined by response criteria for PTCL
  • Age ≥ 18.
  • Patients with Hepatitis C can be included if they have completed therapy for hepatitis C with undetectable viral load.
  • Patients with Hepatitis B can be included if they are on suppressive therapy for hepatitis B infection and with no detectable viral load.
  • Patients with HIV can be included if they are on appropriate antiretroviral therapy, there is no interaction with the study drug, a CD4+ T-cell counts ≥ 350 cells/µL and no detectable viral load.
  • Adequate organ function as defined below unless attributed to disease involvement (Note: transfusions and growth factors allowed during screening; however, transfusion-dependency defined as requiring blood products ≥once per week not allowed):
  • Liver function: No more than moderate hepatic impairment per NCI ODWG criteria - Total bilirubin ≤ 3X upper limit of normal (ULN), AST ≤ ULN (unless attributed to fatty liver or disease involvement).
  • Kidney function: CrCl > 30ml/min using Cockroft-Gault, based on actual weight.
  • ANC ≥ 1,000/µL, Platelet Count ≥ 75,000/ µL, Hemoglobin ≥ 8.0 g/dl.
  • Left ventricular ejection fraction (LVEF) defined by multiple-gated acquisition (MUGA) scan or echocardiogram within the institutional limits of normal.
  • Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2.
  • A negative urine or serum pregnancy test is required for all women of childbearing potential within 1 week prior to enrolling on this trial and within 3 days of first dose of study drug. Note: Urine pregnancy tests that cannot be confirmed as negative require a confirmatory negative serum pregnancy test.
  • Non-childbearing potential is defined as:
  • Postmenopausal: Defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, FSH measurements indicating post-menopausal status must be documented in patient's medical history.
  • Permanently sterile: Documented permanent sterilization e.g., hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
  • If female of childbearing potential, subject must not be pregnant or be breastfeeding and is required to have a negative urine or serum pregnancy test within 3 days prior to the first dose of study drug. In addition, females of childbearing potential must either practice complete abstinence or agree to use two effective methods of contraception simultaneously, beginning ≥ 28 days prior to start of tazemetostat, during tazemetostat treatment, and for at least 6 months after final dose of tazemetostat. See Appendix E regarding contraception guidelines.
  • Male subjects must either practice complete abstinence or agree to use a latex or synthetic condom during any sexual contact with a female of childbearing potential, from first dose of tazemetostat, during study treatment including dose interruptions, and for 3 months after last dose of tazemetostat. This applies even to males who have undergone successful vasectomy with medically confirmed azoospermia.
  • Willing and able to participate in all required evaluations and procedures in this study protocol including receiving intravenous administration of investigational product and being admitted, when required, for at least 24 hours during investigational product administration.

Who cannot join

  • Current evidence of central nervous system involvement.
  • Completion of an autologous hematopoietic stem cell transplantation within 3 months prior to first dose of study drug.
  • Prior allogeneic stem cell transplant within 6 months. The patient should not have any active GVH or should be on immune suppressive agents.
  • Completion of treatment with any radiotherapy, chemotherapy, antibody, immunoconjugates and/or another investigational drug ≤4 weeks (or 5 half-lives of the drug, whichever is shorter) prior to first dose of study drug. Patients may be enrolled after a minimum of 2 weeks of radiation if radiation was for palliative intent.
  • Prior therapy with an EZH2 inhibitor.
  • Inability to swallow and retain oral medications.
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  • Pregnant women are excluded from this study.
  • Any active, concurrent, significant illness or disease (other underlying lymphoma) or clinically significant findings including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the patient from participation in the study such as:
  • Active infection requiring systemic therapy ≤10 days before the first dose of study drug; ii. Unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association [NYHA] II, III, IV;), myocardial infarction ≤6 months prior to first study drug, uncontrolled cardiac arrhythmia e.g., atrial fibrillation/flutter, cerebrovascular accidents ≤6 months before first dose of study drug; iii. Any severe or uncontrolled other disease or condition which might increase the risk associated with study participation.
  • Vaccination with live, attenuated vaccines within 28 days prior to the first dose of study medication.
  • Receiving systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents). The use of inhaled corticosteroids is permitted.
  • Corticosteroids ≥ 10 mg of prednisone within the last 7 days.
  • Has had a solid organ transplant within the last 3 years. Note: Patients who have had a solid organ transplant >3 years ago are eligible if there are no signs/symptoms of graft versus host disease (GvHD) and off immunosuppressive medications as per above.
  • Any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN).
  • Any prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL).
  • Patients with the following subtypes of lymphoma:
  • T-cell prolymphocytic leukemia ii. T-large granular lymphocytic leukemia iii. NK-large granular lymphocytic leukemia iv. Aggressive NK-cell leukemia v. Breast implant-associated anaplastic large-cell lymphoma
  • Any other malignancy known to be active, with the exception of i. Cervical carcinoma of Stage 1B or less ii. Non-invasive basal cell or squamous cell skin carcinoma iii. Non-invasive, superficial bladder cancer iv. Prostate cancer with a current PSA level < 0.1 ng/mL v. Any curable or localized cancer with a CR of > 2 years' duration.
  • Any malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat.
  • Major surgery within 4 weeks before the first dose of study intervention. Note: Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrolment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: Phase I Study to Evaluate Safety and Tolerability of Tazemetostat in Relapsed/Refractory Peripheral T-cell Lymphoma

Tazemetostat is an oral EZH2 inhibitor which has been FDA approved for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment option. We propose a study to evaluate the safety of tazemetostat in relapsed / refractory peripheral T-cell lymphoma.

Conditions
T-cell Lymphoma
Being tested
Tazemetostat
Keywords
T-cell Lymphoma, Leukemia, Lymphoma
Medical subject headings
Lymphoma, T-Cell, Leukemia, Lymphoma

What participants receive

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

  • TazemetostatDrug

    Treatment: On day 1 and day 15 of the first cycle, and day 1 of all following cycles, the subject will have office visit with physical exam, vital signs, and lab tests. The subject will take tazemetostat twice a day by mouth continuously as an outpatient. If continuing on the treatment for more than 6 cycles, visits change to every 3 months.

Study groups in NCT05983965
Study groupRoleWhat they receive
Cohort AExperimentalT-cell Lymphomas
Receives: Drug: Tazemetostat

What is being measured

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

  1. Identify the recommended phase II dose of Tazemetostat

    The measurement will be the occurrence of a dose limiting toxicity (DLT) in the first cycle (28 days) after treatment initiation from the start of cycle 1 day 1.

    Measurements will be graded on a Hematologic Toxicity scale from grades 1 through 4 with grade 4 being worst grade.

    Measured: 28 days

Timeline

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

  1. First posted9 Aug 2023
  2. Study start5 Sep 2024
  3. Primary completion6 Mar 2026
  4. Study completion6 Mar 2026

Why it stopped: Ipsen, drug company requested all studies using the drug Taxemetostat be terminated due to increased risk of secondary malignancies in subjects.

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
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05983965
Sponsor's protocol ID
IRB-300011353
Other IDs
Robert Award
Status last verified
Apr 2026
First submitted
1 Aug 2023
Last updated
17 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tazemetostat in people with T-cell Lymphoma, run by University of Alabama at Birmingham at 1 site 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 33 inclusion and 20 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: stopped early, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early (reason given: Ipsen, drug company requested all studies using the drug Taxemetostat be terminated due to increased risk of secondary malignancies in subjects.). Results are not available in the source record.

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?

Identify the recommended phase II dose of Tazemetostat (time frame: 28 days). 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 NCT05983965.

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 17 Apr 2026.

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