24 Participants Needed

Tazemetostat + CHOP for T-Cell Lymphoma

Recruiting at 2 trial locations
EJ
Overseen ByEric Jacobsen, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should not be on other investigational agents and should not have had prior chemotherapy for T-cell lymphoma, except for one cycle of CHOP/CHOEP or a short course of corticosteroids. It's best to discuss your current medications with the trial team.

Is the combination of Tazemetostat and CHOP safe for treating T-Cell Lymphoma?

The safety of Tazemetostat and CHOP for T-Cell Lymphoma isn't directly addressed in the provided studies, but some components like Vincristine (part of CHOP) have been studied for other conditions. Vincristine is known to be effective in inhibiting cell growth, but the safety profile for this specific combination in T-Cell Lymphoma isn't detailed here.12345

What makes the drug Tazemetostat + CHOP unique for T-Cell Lymphoma?

The combination of Tazemetostat with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) is unique because Tazemetostat is a histone deacetylase inhibitor, which can enhance the effectiveness of chemotherapy by promoting cancer cell death. This approach may offer a novel mechanism of action compared to traditional chemotherapy regimens for T-Cell Lymphoma.678910

What data supports the effectiveness of the drug Tazemetostat + CHOP for T-Cell Lymphoma?

Research shows that combining doxorubicin, a component of CHOP, with other drugs like histone deacetylase inhibitors can enhance its effectiveness in treating certain cancers, such as sarcomas. This suggests that similar combinations might improve outcomes in T-Cell Lymphoma.611121314

Who Is on the Research Team?

Eric D. Jacobsen, MD - Dana-Farber ...

Eric Jacobsen, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals with various types of T-cell lymphoma, including peripheral and intestinal forms. Participants should be suitable for chemotherapy. Specific eligibility criteria are not provided, but typically include factors like age, disease stage, and overall health.

Inclusion Criteria

My organs and bone marrow are working well.
Ability to understand and sign a written informed consent document
Agree to use adequate contraception
See 8 more

Exclusion Criteria

I have had an organ transplant.
I have nerve damage affecting my movements or sensations that is mild or worse.
I have not had major surgery in the last 4 weeks.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Prephase

Participants receive a predetermined dose of Tazemetostat twice daily

2 weeks
1 visit (in-person)

Induction

Participants receive CHOP chemotherapy and Tazemetostat over 6 cycles of 21 days each

18 weeks
Multiple visits (in-person) for each cycle

Maintenance

Participants receive Tazemetostat daily for 6 cycles of 28 days each

24 weeks
Regular visits (in-person) for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years
Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Doxorubicin
  • Melphalan
  • Tazemetostat
  • Vincristine
Trial Overview The study is testing the effectiveness of tazemetostat (an EZH2 inhibitor) combined with CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone) against T-cell lymphoma. Some patients may also receive BEAM conditioning before a stem cell transplant.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Tazemetostat + CHOP Therapy + Transplant Not ElectedExperimental Treatment5 Interventions
Group II: Tazemetostat + CHOP Therapy + Transplant ElectedExperimental Treatment9 Interventions

Doxorubicin is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Adriamycin for:
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Approved in European Union as Doxorubicin for:
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Approved in Canada as Doxorubicin for:
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Approved in Japan as Doxorubicin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eric Jacobsen, MD

Lead Sponsor

Trials
1
Recruited
20+

Ipsen

Industry Sponsor

Trials
358
Recruited
74,600+
David Loew profile image

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri profile image

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD

Published Research Related to This Trial

Targeted therapies combined with doxorubicin showed significant effectiveness against small cell sarcoma cell lines, with dual combinations of vorinostat and 17-DMAG achieving synergistic effects that enhanced cell killing by 60% compared to doxorubicin alone.
The study found that while vorinostat and 17-DMAG synergized with doxorubicin, sorafenib did not, and the combination of all three agents did not show synergy but increased apoptosis, indicating potential for improved treatment strategies in advanced sarcoma.
Targeted polytherapy in small cell sarcoma and its association with doxorubicin.Dumont, SN., Yang, D., Dumont, AG., et al.[2021]
Belinostat, when combined with doxorubicin, was well tolerated in a study of 41 patients, with a maximum tolerated dose established at 1000 mg/m² for belinostat and 75 mg/m² for doxorubicin, despite common side effects like fatigue and nausea.
The combination therapy showed a moderate response rate of 13% in soft tissue sarcomas, with a median time to progression of 6.0 months, suggesting it may be more effective than doxorubicin alone in some cases.
A Phase I/II Clinical Trial of Belinostat (PXD101) in Combination with Doxorubicin in Patients with Soft Tissue Sarcomas.Vitfell-Rasmussen, J., Judson, I., Safwat, A., et al.[2020]
In a study of 101 lymphoma patients undergoing autologous stem cell transplantation, the mitoxantrone-melphalan (Mx-Mel) regimen showed similar efficacy to the BEAM regimen while being less toxic, making it a promising alternative for patients who cannot tolerate high cytotoxic treatments.
Although the BEAM regimen resulted in a statistically shorter time to neutrophil engraftment (10 days) compared to Mx-Mel (12 days), both regimens did not lead to significant differences in transplant-related complications, indicating that Mx-Mel is a safe option with effective outcomes.
Comparison of Mitoxantrone-Melphalan and BEAM Conditioning Regimens in Patients with Lymphoma.Gunes, AK., Serin, I., Demir, I., et al.[2023]

Citations

Phase 1 study of oral abexinostat, a histone deacetylase inhibitor, in combination with doxorubicin in patients with metastatic sarcoma. [2021]
Targeted polytherapy in small cell sarcoma and its association with doxorubicin. [2021]
A Phase I/II Clinical Trial of Belinostat (PXD101) in Combination with Doxorubicin in Patients with Soft Tissue Sarcomas. [2020]
The histone deacetylase inhibitor vorinostat selectively sensitizes fibrosarcoma cells to chemotherapy. [2021]
Comparison of Mitoxantrone-Melphalan and BEAM Conditioning Regimens in Patients with Lymphoma. [2023]
Antineoplastic agents for pediatric anaplastic large cell lymphoma: Vinblastine is the most effective in vitro. [2019]
Topotecan, Ara-C, cisplatin and prednisolone (TOPOSHAP) for patients with refractory and relapsing lymphomas: results of a phase I trial. [2013]
Stevens-Johnson Syndrome-Like Exanthema Secondary to Methotrexate. [2016]
A phase I study of idarubicin dose escalation with amisfostine and high-dose cytarabine in patients with relapsed acute myelogenous leukemia and myelodysplastic syndromes. [2013]
Adverse effects with intravenous methotrexate in children with acute lymphoblastic leukemia/lymphoma: a retrospective study. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Effective treatment of a murine model of adult T-cell leukemia using depsipeptide and its combination with unmodified daclizumab directed toward CD25. [2021]
Belinostat in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone as first-line treatment for patients with newly diagnosed peripheral T-cell lymphoma. [2021]
CHOEP-21 chemotherapy for newly diagnosed nodal peripheral T-cell lymphomas (PTCLs) in Maharaj Nakorn Chiang Mai Hospital. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Novel therapies for cutaneous T-cell lymphomas. [2018]
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