WithdrawnPhase 2

Tazemetostat Plus CHOP in 1L T-cell Lymphoma

Stopped: Ipsen requested a temporary closure due to a safety concern.

0Started 2024-12-24

Plain-language summary

This research is being done to evaluate tazemetostat in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy as a possible treatment for peripheral T-Cell Lymphoma (PTCL). The name of the study drugs involved in this study are: * Tazemetostat (a type of inhibitor for Enhancer of Zeste Homolog 2 (EZH2)) * Standard of care CHOP therapy: * Cyclophosphamide (a type of alkylating agent) * Doxorubicin (a type of anthracycline antibiotic) * Vincristine (a type of vinca alkaloid) * Prednisone (a type of corticosteroid) * Standard of care BEAM conditioning regimen for autologous stem cell transplant: * Carmustine (a type of alkylating agent) * Etoposide (a type of Topoisomerase II inhibitor) * Cytarabine (a type of antineoplastic) * Melphalan (a type of alkylating agent)

Who can participate

Age range

18 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: * Participants must have histologically or cytologically confirmed peripheral T cell lymphoma of one of the following subtypes: PTCL-NOS, Follicular helper T-cell lymphoma (ICC 2022) or Nodal T-follicular helper (TFH) cell lymphoma by (WHO 2022) which includes follicular helper T-cell lymphoma, AITL and follicular helper T cell lymphoma, follicular type, EATL, MEITL. All pathology will be reviewed at BWH. BWH review is not required prior to enrollment and patients may be enrolled based upon local pathology analysis. Ten blank slides will be required from outside tumor biopsy for correlative studies. * No prior treatment for T NHL with the exception of one cycle of CHOP or CHOEP or 7 days of corticosteroids at a dose of up to prednisone 60 mg or equivalent for palliation of disease related symptoms so long as the corticosteroids are discontinued prior to tazemetostat prephase or cycle 1 of treatment if not receiving the prephase. * At least one bi-dimensionally measurable lesion, defined as \>1.5 cm in its longest dimension as measured by CT. * Age ≥18 years. * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A). * Participants must have adequate organ and marrow function as defined below: * absolute neutrophil count ≥1,000/mcL (750 mcl if bone marrow involvement with lymphoma) * platelets ≥75,000/mcL (25,000 if bone marrow involvement with lymphoma) * total bilirubin ≤ institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤3 × i…

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.

1This trial has been listed as withdrawn — do you know why it was pulled before enrolling patients, and does that affect whether tazemetostat combined with CHOP is still worth considering for my type of T-cell lymphoma?
2Since this was a Phase 2 study designed to measure complete response rates, are there any early results or related studies on tazemetostat plus CHOP that you've seen, and what do they suggest about how well this combination might work compared to CHOP alone?
3My diagnosis falls under peripheral T-cell lymphoma — given that this specific trial is no longer recruiting, are there other active clinical trials testing similar combinations that you think would be worth exploring for my situation?
4Because this trial was withdrawn before completing, how does that affect what we know about the safety of adding tazemetostat to CHOP, and would standard CHOP chemotherapy be a more proven starting point for me right now?
5Is there anything about my specific subtype — whether it's angioimmunoblastic, enteropathy-associated, or another form of T-cell lymphoma — that would make a tazemetostat-based approach particularly promising or risky if a similar trial becomes available?

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

Complete Response Rate (CRR)

Timeframe: Up to 18 weeks

Trial details

NCT IDNCT06692452

SponsorEric Jacobsen, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-01

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