Peripheral T Cell LymphomaPhase 2NCT05963347
Go-CHOP as the Frontline Therapy for PTCL
A Phase 2 study testing Golidocitinib and CHOP Regimen in people with Peripheral T Cell Lymphoma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in Combination with CHOP as the front-line Treatment for Participants with Peripheral T-cell Lymphomas (PTCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- Golidocitinib and CHOP Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2023to 31 Jul 2026
- Phase
- Phase 2
- 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
- Participants must sign an informed consent form prior to trial-specific procedures, sampling, and analysis.
- Participants must be at least 18 years of age (inclusive) at the time of signing the informed consent form.
- The participant has an ECOG performance status of 0 to 2 and has not deteriorated in the past 2 weeks.
- Life expectancy ≥ 3 months.
- Histologically confirmed diagnosis of PTCL and no prior systemic anti-lymphoma therapy; and assessed by a local pathologist according to the 2016 revised World Health Organization Classification of Lymphoid Tumors (Swerdlow SH et al., 2017) as the following subtypes:
- peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS)
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- angioimmunoblastic T cell lymphoma (AITL)
- follicular T-cell lymphoma (FTCL)
- nodular PTCL with follicular helper T-cell phenotype (nodular PTCL with TFH phenotype)
- ALK- anaplastic large cell lymphoma (ALK- ALCL)
- ALK+ anaplastic large cell lymphoma (ALK + ALCL)
- enteropathy-associated T-cell lymphoma (EATL)
- monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)
- hepatosplenic T-cell lymphoma (HSTCL)
- subcutaneous panniculitis-like T-cell lymphoma (SPTCL)
- Adequate bone marrow reserve and organ system function reserve
- Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by ECHO.
- Participants should be able and willing to comply with the study protocol requirement.
- Adequate birth control measures should be taken during study treatment and the corresponding washout period.
Who cannot join
- Received any of the following interventions:
- Prior therapy for PTCL prior to enrollment, except short-term corticosteroids (duration ≤ 7 days, equivalent prednisone dose ≤ 15 mg/day).
- Prior radiation therapy for PTCL except local therapy for individual areas.
- Currently receiving other systemic antineoplastic or investigational therapy.
- Participants who have received more than 200 mg/m2 doxorubicin or other equivalent doses of anthracycline/anthraquinone (e.g., epirubicin, daunorubicin, mitoxantrone, etc.) cumulatively.
- Major surgical procedures (excluding routine lymphoma care programs such as vascular access placement, biopsy, etc.) or significant trauma within 4 weeks prior to the first dose of study treatment, or anticipation of the need for major surgery during the study.
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- Prior treatment with JAK or STAT3 inhibitors following diagnosis of PTCL.
- Live vaccine within 28 days prior to enrollment.
- Participants currently receiving (or unable to discontinue for at least 1 week prior to first dose) vitamin K antagonists, antiplatelets, or anticoagulants.
- Participants currently receiving (or unable to discontinue for at least 1 week prior to receiving the first dose) medications or herbal supplements known to be highly potent inhibitors or inducers of CYP3A or sensitive substrates of BCRP or P-gp with a narrow therapeutic index (see Section 6.8).
- Participants with clinical manifestations or imaging findings suggesting central nervous system or leptomeningeal lymphoma.
- Participants with severe lung dysfunction, pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any prior history of clinically active interstitial lung disease.
- Participants with a condition that requires treatment with immunosuppressants, biologics, or nonsteroidal anti-inflammatory drugs (NSAIDs).
- Participants with active infections
- Participants with significant cardiac disorder
- Other malignancies within 3 years before enrollment. However, malignancies, such as uterine and cervical carcinoma in situ, basal or squamous cell carcinoma, and non-melanotic skin cancer, which have been clinically cured after evaluation, may be considered for inclusion after evaluation.
- Refractory nausea or vomiting that cannot be controlled by supportive therapy, chronic gastrointestinal disease, inability to swallow pharmaceutical agents or previous major bowel resection may affect the adequate absorption of golidocitinib.
- Female participants who are lactating.
- Participants with a history of hypersensitivity against the active ingredients or excipients of golidocitinib or against similar chemical structures or drugs of the same class. Contraindication to any agent in the CHOP chemotherapy regimen.
- Participants with any severe or poorly controlled systemic disease, such as poorly controlled hypertension or active bleeding constitution, as judged by the investigator or other evidence.
- Participants with an intercurrent illness that, in the opinion of the investigator, may jeopardize compliance with the protocol, including any significant medical condition, laboratory abnormality, or psychiatric disorder.
- Participants with psychological, familial, social, or geographical conditions that preclude compliance with the program. Any condition that would confound the ability to interpret study data.
- Participating in study planning and implementation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Keshu Zhou, Dr., +86 (0371) 65587513, drzhouks77@163.com
About this study
Official title: A Phase 2 Study to Investigate the Safety, Tolerability and Anti-tumor Activity of Golidocitinib in Combination With CHOP as the Front-line Treatment for Participants With Peripheral T-cell Lymphomas (PTCL)
This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in Combination with CHOP as the front-line Treatment for Participants with Peripheral T-cell Lymphomas (PTCL).
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- Golidocitinib, CHOP Regimen
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolidocitinibDrug
Also called AZD4205, DZD4205
Daily dose. Starting dose of golidocitinib is 75 mg QD. If tolerated, subsequent cohorts will test ascending doses of golidocitinib.
CHOP RegimenDrug
Also called Cyclophosphamide, doxorubicin, vincristine, prednisone
CHOP will be administered in a 21-day cycle for a maximum of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Go-CHOP | Experimental | Golidocitinib in combination with CHOP Receives: Drug: Golidocitinib; Drug: CHOP Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
TEAE, lab test
Measured: From first dose till 28 days post the last dose
Secondary outcomes (4)
Complete Response Rate
Complete response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria
Measured: From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)
Objective Response Rate
Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria.
Measured: From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)
Progression Free Survival
Objective response rate by Cycle 3 and Cycle 6 assessed by investigator per Lugano 2014 criteria.
Measured: From date of enrollment (first dose) until documented disease progression or death of any reason (up 2 year)
Duration of Response
Duration of response assessed by investigator per Lugano 2014 criteria
Measured: from first documented response till disease progression or death of any reason (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start3 Aug 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, KeshuZhou, Henan Cancer Hospital
- Investigators
- Keshu Zhou, Dr., Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963347
- Sponsor's protocol ID
- DZ2022J0003
- Status last verified
- Aug 2023
- First submitted
- 10 Jul 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Investigate the Safety, Tolerability and Anti-tumor Activity of Golidocitinib in Combination With CHOP as the Front-line Treatment for Participants With Peripheral T-cell Lymphomas (PTCL)
- ClinicalTrials.gov ID
- NCT05963347
- Acronym / sponsor ID
- DZ2022J0003
- Conditions
- Peripheral T Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in Combination with CHOP as the front-line Treatment for Participants with Peripheral T-cell Lymphomas (PTCL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Go-CHOP | Experimental | Drug: Golidocitinib, Drug: CHOP RegimenGolidocitinib in combination with CHOP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Participants must sign an informed consent form prior to trial-specific procedures, sampling, and analysis.
- Participants must be at least 18 years of age (inclusive) at the time of signing the informed consent form.
- The participant has an ECOG performance status of 0 to 2 and has not deteriorated in the past 2 weeks.
- Life expectancy ≥ 3 months.
- Histologically confirmed diagnosis of PTCL and no prior systemic anti-lymphoma therapy; and assessed by a local pathologist according to the 2016 revised World Health Organization Classification of Lymphoid Tumors (Swerdlow SH et al., 2017) as the following subtypes:
Key exclusion criteria (23 listed)
- Received any of the following interventions:
- Participants with clinical manifestations or imaging findings suggesting central nervous system or leptomeningeal lymphoma.
- Participants with severe lung dysfunction, pneumonitis, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any prior history of clinically active interstitial lung disease.
- Participants with a condition that requires treatment with immunosuppressants, biologics, or nonsteroidal anti-inflammatory drugs (NSAIDs).
- Participants with active infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GolidocitinibAlso: AZD4205, DZD4205Daily dose. Starting dose of golidocitinib is 75 mg QD. If tolerated, subsequent cohorts will test ascending doses of golidocitinib. | Drug | Go-CHOP |
| CHOP RegimenAlso: Cyclophosphamide, doxorubicin, vincristine, prednisoneCHOP will be administered in a 21-day cycle for a maximum of 6 cycles. | Drug | Go-CHOP |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From first dose till 28 days post the last dose
TEAE, lab test
4 secondary outcomes
Complete Response Rate
Time frame: From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)
Objective Response Rate
Time frame: From date of enrollment (first dose) until the end of induction therapy completed (~ 18 weeks)
Progression Free Survival
Time frame: From date of enrollment (first dose) until documented disease progression or death of any reason (up 2 year)
Duration of Response
Time frame: from first documented response till disease progression or death of any reason (up to 2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keshu Zhou, Dr. principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Golidocitinib and CHOP Regimen in people with Peripheral T Cell Lymphoma, run by Henan Cancer Hospital at 1 site in China.
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 19 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keshu Zhou, Dr. (+86 (0371) 65587513, drzhouks77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: From first dose till 28 days post the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2023.