Golidocitinib for Peripheral T-Cell Lymphoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: Corticosteroids, JAK inhibitors, others
Disqualifiers: CNS lymphoma, Severe lung disease, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot take medications or supplements that affect CYP3A activity at least one week before starting the trial. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Golidocitinib for treating peripheral T-cell lymphoma?
Golidocitinib, a drug that targets a specific protein involved in cell growth, has shown promising results in early studies for patients with peripheral T-cell lymphoma who did not respond to previous treatments. In a phase 2 study, it demonstrated anti-tumor activity, suggesting it may be effective for this condition.
12345Is Golidocitinib safe for humans?
Golidocitinib has been studied in patients with relapsed or refractory peripheral T-cell lymphoma, showing encouraging results in early trials. While specific safety data is not detailed in the provided studies, it has been evaluated in phase 1 and 2 trials, which typically assess safety and tolerability in humans.
12678How is the drug Golidocitinib different from other treatments for peripheral T-cell lymphoma?
Golidocitinib is unique because it is an oral drug that specifically targets JAK1, a protein involved in the growth of cancer cells, making it different from traditional chemotherapy which is less targeted. This selectivity may offer a new option for patients with relapsed or refractory peripheral T-cell lymphoma, a condition with limited effective treatments.
128910Eligibility Criteria
This trial is for individuals newly diagnosed with Peripheral T Cell Lymphoma (PTCL). Specific eligibility details are not provided, but typically participants must meet certain health standards and may need to have a particular stage or type of PTCL.Inclusion Criteria
Predicted life expectancy ≥ 12 weeks
Participants must have measurable disease according to the 2014 Lugano classification
Provision of a signed and dated, written informed consent form prior to any study specific procedures, sampling, and analyses
+11 more
Exclusion Criteria
My heart health meets the study's requirements.
I do not have any severe illnesses, uncontrolled high blood pressure, or active bleeding disorders.
Intervention with investigational anti-cancer agents or anti-cancer study drugs, cytotoxic chemotherapy, corticosteroids at dosages equivalent to prednisone > 40 mg/day within 7 days of the start of the study treatment, major surgery procedure, prior treatment with a JAK or STAT3 inhibitor, prior treatment with any onco-immunotherapy in 28 days prior to first dosing of golidocitinib, live vaccines within 28 days prior to first dose, medications or herbal supplements known to be potent inhibitors or inducers of CYP3A
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive golidocitinib alone or in combination with CHOP to control PTCL
1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing the effectiveness and safety of golidocitinib, alone or combined with CHOP therapy (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone), in treating PTCL. It's a Phase II trial focused on understanding how well this new treatment works.
1Treatment groups
Experimental Treatment
Group I: Golidocitinib + CHOPExperimental Treatment5 Interventions
Golidocitinib will be administered at 150 mg PO daily as monotherapy unless dose modified per toxicity chart; when in combination with CHOP, the maximum dose of golidocitinib is 150 mg PO every other day
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, in patients with refractory or relapsed peripheral T-cell lymphoma (JACKPOT8 Part B): a single-arm, multinational, phase 2 study. [2023]Golidocitinib, a selective JAK1 tyrosine-kinase inhibitor, has shown encouraging anti-tumour activity in heavily pre-treated patients with relapsed or refractory peripheral T-cell lymphoma in a phase 1 study (JACKPOT8 Part A). Here, we report the full analysis of a phase 2 study, in which we assessed the anti-tumour activity of golidocitinib in a large multinational cohort of patients.
Phase I dose escalation and expansion study of golidocitinib, a highly selective JAK1 inhibitor, in relapsed or refractory peripheral T-cell lymphomas. [2023]Relapsed or refractory peripheral T-cell lymphomas (r/r PTCLs) are a group of rare and aggressive diseases that lack effective therapies. Constitutive activation of the Janus kinase (JAK)/signal transducer and activator of transcription (STAT) pathway is reported to be associated with PTCLs. Golidocitinib is an oral, potent JAK1 selective inhibitor evaluated in a phase I/II multinational study in patients with r/r PTCLs.
Outcomes for Relapsed and Refractory Peripheral T-Cell Lymphoma Patients after Front-Line Therapy from the COMPLETE Registry. [2020]Outcomes for patients with peripheral T-cell lymphoma (PTCL) who fail to achieve complete response (CR) or relapse after front-line therapy are poor with lack of prospective outcomes data.
Combination treatment of copanlisib and gemcitabine in relapsed/refractory PTCL (COSMOS): an open-label phase I/II trial. [2022]Current treatment options for peripheral T-cell lymphomas (PTCLs) in the relapsed/refractory setting are limited and demonstrate modest response rates with rare achievement of complete response (CR).
Prognostic value of baseline total metabolic tumor volume (TMTV0) measured on FDG-PET/CT in patients with peripheral T-cell lymphoma (PTCL). [2022]Most peripheral T-cell lymphoma (PTCL) patients have a poor outcome and the identification of prognostic factors at diagnosis is needed.
A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. [2020]This multicentre, single-arm, open-label phase 2 trial investigated the efficacy and safety of lenalidomide monotherapy in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).
Novel therapies for peripheral T-cell lymphomas. [2021]Peripheral T-cell lymphomas (PTCLs) are a diverse family of lymphoid neoplasms with poor prognosis. They represent approximately 6-10% of non-Hodgkin lymphomas with significant geographic variation. The median age at diagnosis varies with histology, however the majority of patients with PTCL are in their fifth or sixth decade of life. Until recently clinical development of new agents for PTCL was slow due to difficulties in making the correct diagnosis, lack of uniform classification and combination of rarity and biologic diversity of the group. In the last 5 years, significant advances were made to overcome these obstacles, leading to the approval of three new agents for relapsed and refractory PTCL by the Food and Drug Administration, based on well conducted prospective studies. Pralatrexate, a unique antifol, was the first agent granted approval, followed by romidepsin, a histone deacetylase inhibitor, and brentuximab vedotin, an immunoconjugate. Owing to the unique nature of these agents, durable responses were seen in patients with highly refractory disease, and some of these responses are long lasting after discontinuation of therapy. Accumulating data indicate that these novel agents have little cumulative toxicity and can be administered continuously to patients who are not candidates for consolidative stem-cell transplantation (SCT), with little impact on quality of life. They might also provide a new salvage option for patients eligible for SCT with no impact on autologous stem-cell collection or subsequent engraftment. New studies are underway to evaluate efficacy and safety of new agents in combination regimens for both newly diagnosed and relapsed/refractory PTCL. Several other investigational drugs showed promise in recent trials. This review focuses on novel therapies for T-cell lymphomas, their place in current treatment paradigms and future directions.
Current Treatment of Peripheral T-cell Lymphoma. [2022]The peripheral T-cell lymphomas (PTCLs) are a notoriously diverse family of non-Hodgkin lymphomas with generally aggressive biology. Clinical management is challenging given a largely inadequate literature base comprised of few randomized trials and heterogeneous observational reports. Herein, we provide an account of our practice in the treatment of the 3 most common nodal PTCLs: PTCL, not otherwise specified, angioimmunoblastic T-cell lymphoma, and anaplastic large cell lymphoma (ALCL). In the up-front setting, we employ anthracycline-based induction, with the incorporation of brentuximab vedotin for all those with ALCL and consideration in those with other CD30-expressing PTCLs based on improved progression-free and overall survival in the absence of additional toxicity in the ECHELON-2 trial. We strongly consider high-dose therapy with autologous stem cell rescue in first complete remission. In the relapsed or refractory (R/R) setting, we often look to clinical trials or choose from 4 FDA-approved single agents-belinostat, brentuximab vedotin, romidepsin, and pralatrexate-based on tumor phenotype and side-effect profiles. Our goal in the R/R setting is achievement of complete remission followed by allogeneic transplant with curative intent in appropriate candidates or long-term disease control in others. Numerous investigational agents are advancing through trials and have potential to alter standards of care in the near future.
Peripheral T-cell lymphomas in a large US multicenter cohort: prognostication in the modern era including impact of frontline therapy. [2021]Optimal frontline therapy for peripheral T-cell lymphoma (PTCL) in the modern era remains unclear.
Advances and Personalized Approaches in the Frontline Treatment of T-Cell Lymphomas. [2023]Peripheral T-cell lymphomas (PTCLs) are a rare and heterogenous subset of non-Hodgkin lymphoma characterized by an aggressive clinical course. Historically, the treatment of PTCLs have been analogous to that of aggressive B-cell lymphomas; however, it has been well-established that overall responses and complete remission rates are far inferior using near-identical chemotherapy strategies. Recently, there has been a plethora of newer agents designed to target distinguishing cellular and molecular features of specific PTCL subtypes. These agents have been proven to yield superior anti-lymphoma responses and, in some cases, overall survival in the relapsed, refractory, and frontline treatment setting. In this review, we will summarize and highlight the most influential clinical trials leading to the Food and Drug Administration (FDA) approval of several novel therapeutic agents against PTCL, with an emphasis on emerging studies and strategies to expand their potential use in the frontline treatment setting.