PI3Kδ InhibitorPhase 1/2NCT05238064
Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL
A Phase 1/2 study testing Parsaclisib and CHOP in people with PI3Kδ Inhibitor and Parsaclisib, run by Fudan University.
Trial summary
The study is to investigate the safety, tolerability and efficacy of PI3Kδ inhibitor Parsaclisib in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in frontline treatment of patients with peripheral T-cell lymphoma (PTCL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PI3Kδ Inhibitor, Parsaclisib, CHOP
- What is being tested?
- Parsaclisib and CHOP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Dec 2025
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects fully understand and voluntarily participate in this study and sign informed consent
- 2. Age≥18, ≤70 years
- 3. Histologically confirmed diagnosis of treatment-naïve PTCL, including peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL, ALK+ALCL with IPI≥2, no limitation with ALC-ALCL), angioimmunoblastic T-cell lymphoma (AITL), enteropathy related T-cell lymphoma, hepatosplenic T-cell, γ/δ T-cell lymphoma; Other PTCL that investigators consider to be appropriate to be enrolled.
- 4. No previous systemic treatment before enrollment.
- 5. At least one measurable lesions according to LUGANO 2014 criteria.
- 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
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- 7. Life expectancy ≥3 months.
- 8. Ineligible or decline to receive autologous stem cell transplantation (ASCT).
- 9. Adequate main organ function defined as the following required baseline laboratory data: Absolute neutrophil count (ANC)≥1.5×109/L without given G-CSF within 14 days; Platelet count (PLT)≥75×109/L without given transfusion with 14 days; Hemoglobin (HB)≥8g/dL without given transfusion or erythropoietin; Total bilirubin (TBIL)≤1.5X upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5X ULN; Serum creatinine (Scr)≤1.5X ULN; Left ventricular ejection fraction (LVEF)≥50%; For female participants of childbearing period, a negative urine or serum pregnancy test should be performed with 1 week prior to receiving first dose of investigational drug (day 1 of cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age was defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.
- 10.If there is a risk of pregnancy, all participants (both men and women) are required to use a contraceptive with an annual failure rate of less than 1% for entire treatment period up to 120 days after the last dose of investigational drug (or 180 days after chemotherapeutic drug).
Who cannot join
- 1. Current or previous history of other malignancies within 5 years prior to study enrollment.
- 2. Current diagnosis of any of the following: Adult T-cell leukemia/lymphoma, precursor cell lymphoblastic leukemia/lymphoma, extranodal natural killer/T-cell lymphoma, nasal type (ENKTL), indolent cutaneous T-cell lymphoma (CTCL).
- 3. Target lesions were treated with radiotherapy within 4 weeks of enrollment.
- 4. Patients undergo interventional clinical trials.
- 5. Concurrent lymphoma with CNS invasion.
- 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
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- 7. Known allergy to the active ingredients or excipients of IBI376 and CHOP regimens.
- 8. A known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).
- 9. Positive test results for HBsAg antigen and HBV-DNA, or hepatitis C virus (HCV) antibody.
- 10. Received live vaccine within 30 days prior to initial investigational drug administration (day 1 of cycle 1) (Note: inactivated virus vaccine for injection is allowed within 30 days prior to initial administration, but live attenuated vaccine is not allowed).
- 11. Pregnant or breastfeeding women.
- 12. Any serious uncontrolled systemic disease.
- 13. Any medical history or disease evidence that may interfere with the study results or other conditions that investigators consider inappropriate for the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: PI3Kδ Inhibitor Parsaclisib in Combination With Cyclophosphamide, Doxorubicin, Vincristine and Prednisone in Participants With Previously Untreated Peripheral T-cell Lymphoma
The study is to investigate the safety, tolerability and efficacy of PI3Kδ inhibitor Parsaclisib in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in frontline treatment of patients with peripheral T-cell lymphoma (PTCL).
Read the detailed description
The study is to investigate the safety, tolerability and efficacy of PI3Kδ inhibitor Parsaclisib in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in frontline treatment of patients with peripheral T-cell lymphoma (PTCL) by conducting in two stages, dose-escalation stage and dose-expansion stage. In dose-escalation stage, patients with treated-naïve PTCL will be assigned to receive sequentially higher doses of parsaclisib range from 10 to 20mg po, qd plus CHOP (21 days per cycle). The dose escalation will follow the classic 3+3 design. The recommended phase 2 dose (RP2D) of parsaclisib will be determined according to the dose-escalation results. In dose-expansion stage, additional patients will be recruited to receive Par-CHOP for the planned 6 cycles or until disease progression, unacceptable drug-related adverse events or starting new anti-lymphoma treatments.
- Conditions
- PI3Kδ Inhibitor, Parsaclisib, CHOP, PTCL
- Being tested
- Parsaclisib, CHOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParsaclisibDrug
Also called IBI376
Phase Ib: Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. This stage follows the traditional "3+3" model. Parsaclisib is set at 10 mg/day, 15 mg/day, 20 mg/day 3 dose groups, starting from 10 mg/day, each group included 3 subjects. The final dose determined at this stage will be used in the Phase II study.
Phase II:
Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib.
Maintain treatment: 2.5mg orally every day continuously, once a day until disease progression, death or unacceptable toxicity developments. The maximum treatment time of Parsaclisib is no more than 2 years.
CHOPDrug
Also called Cyclophosphamide, doxorubicin, vincristine and prednison
Cyclophosphamide: 750mg/m2, IV, d1 Doxorubicin: 50mg/m2, IV, d1 Vincristine: 1.4mg/m2, IV, d1 (maximum 2mg) Prednison: 100mg, po, d1-5 21 days per cycle
| Study group | Role | What they receive |
|---|---|---|
| PI3Kδ inhibitor Parsaclisib plus CHOP | Experimental | Phase Ib (Explored the appropriate dose of Parsaclisib in combination with CHOP)
Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day.
CHOP was given at the standard dose, 21 days per cycle
Phase II:
Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib day 1-14 of each cycle, as well as CHOP at standard dose for 6 cycles.
Maintain treatment: Parsaclisib maintenance (2.5mg po, qd) will be performed on CR or PR patients after 6 cycles of induction therapy until disease progression, death, unacceptable toxicity, withdrawal of informed consent, or the investigator's decision or initiation of new antitumor therapy. The maximum maintenance period of parsaclisib is 24 months. Receives: Drug: Parsaclisib; Drug: CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year EFS
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
Measured: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Secondary outcomes (5)
Hematology and non hematology toxicity
number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Throughout the treatment period，up to 6 months
CRR
the ratio of numbers of patients with complete response to all the participants receiving treatment
Measured: at the end of Cycle 6 (each cycle is 21 days)
ORR
the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
Measured: at the end of Cycle 6 (each cycle is 21 days)
EFS
the period from the date of patients sign informed consent to the observed event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment
Measured: From date of randomization until the date of first documented event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment, whichever came first, assessed up to 3 years
OS
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
Measured: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PI3Kδ InhibitorStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junning Cao, MD, Fudan University
- Investigators
- Junning Cao, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238064
- Sponsor's protocol ID
- PTCL-2022-01
- Status last verified
- Feb 2022
- First submitted
- 28 Jan 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PI3Kδ Inhibitor Parsaclisib in Combination With Cyclophosphamide, Doxorubicin, Vincristine and Prednisone in Participants With Previously Untreated Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05238064
- Acronym / sponsor ID
- PTCL-2022-01
- Conditions
- PI3Kδ Inhibitor, Parsaclisib, CHOP, PTCL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Feb 2022 (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.
The study is to investigate the safety, tolerability and efficacy of PI3Kδ inhibitor Parsaclisib in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in frontline treatment of patients with peripheral T-cell lymphoma (PTCL).
Detailed description
The study is to investigate the safety, tolerability and efficacy of PI3Kδ inhibitor Parsaclisib in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in frontline treatment of patients with peripheral T-cell lymphoma (PTCL) by conducting in two stages, dose-escalation stage and dose-expansion stage. In dose-escalation stage, patients with treated-naïve PTCL will be assigned to receive sequentially higher doses of parsaclisib range from 10 to 20mg po, qd plus CHOP (21 days per cycle). The dose escalation will follow the classic 3+3 design. The recommended phase 2 dose (RP2D) of parsaclisib will be determined according to the dose-escalation results. In dose-expansion stage, additional patients will be recruited to receive Par-CHOP for the planned 6 cycles or until disease progression, unacceptable drug-related adverse events or starting new anti-lymphoma treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PI3Kδ inhibitor Parsaclisib plus CHOP | Experimental | Drug: Parsaclisib, Drug: CHOPPhase Ib (Explored the appropriate dose of Parsaclisib in combination with CHOP) Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. CHOP was given at the standard dose, 21 days per cycle Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib day 1-14 of each cycle, as well as CHOP at standard dose for 6 cycles. Maintain treatment: Parsaclisib maintenance (2.5mg po, qd) will be performed on CR or PR patients after 6 cycles of induction therapy until disease progression, death, unacceptable toxicity, withdrawal of informed consent, or the investigator's decision or initiation of new antitumor therapy. The maximum maintenance period of parsaclisib is 24 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Subjects fully understand and voluntarily participate in this study and sign informed consent
- 2. Age≥18, ≤70 years
- 3. Histologically confirmed diagnosis of treatment-naïve PTCL, including peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL, ALK+ALCL with IPI≥2, no limitation with ALC-ALCL), angioimmunoblastic T-cell lymphoma (AITL), enteropathy related T-cell lymphoma, hepatosplenic T-cell, γ/δ T-cell lymphoma; Other PTCL that investigators consider to be appropriate to be enrolled.
- 4. No previous systemic treatment before enrollment.
- 5. At least one measurable lesions according to LUGANO 2014 criteria.
Key exclusion criteria (13 listed)
- 1. Current or previous history of other malignancies within 5 years prior to study enrollment.
- 2. Current diagnosis of any of the following: Adult T-cell leukemia/lymphoma, precursor cell lymphoblastic leukemia/lymphoma, extranodal natural killer/T-cell lymphoma, nasal type (ENKTL), indolent cutaneous T-cell lymphoma (CTCL).
- 3. Target lesions were treated with radiotherapy within 4 weeks of enrollment.
- 4. Patients undergo interventional clinical trials.
- 5. Concurrent lymphoma with CNS invasion.
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 |
|---|---|---|
| ParsaclisibAlso: IBI376Phase Ib: Parsaclisib is taken orally every day continuously, at approximately the same time every day, without food restriction, once a day. This stage follows the traditional "3+3" model. Parsaclisib is set at 10 mg/day, 15 mg/day, 20 mg/day 3 dose groups, starting from 10 mg/day, each group included 3 subjects. The final dose determined at this stage will be used in the Phase II study. Phase II: Induced treatment: Received the initial dose of Parsaclisib determined in Phase Ib. Maintain treatment: 2.5mg orally every day continuously, once a day until disease progression, death or unacceptable toxicity developments. The maximum treatment time of Parsaclisib is no more than 2 years. | Drug | PI3Kδ inhibitor Parsaclisib plus CHOP |
| CHOPAlso: Cyclophosphamide, doxorubicin, vincristine and prednisonCyclophosphamide: 750mg/m2, IV, d1 Doxorubicin: 50mg/m2, IV, d1 Vincristine: 1.4mg/m2, IV, d1 (maximum 2mg) Prednison: 100mg, po, d1-5 21 days per cycle | Drug | PI3Kδ inhibitor Parsaclisib plus CHOP |
Primary outcome
3-year EFS
Time frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
the period from the date of patients sign informed consent to the observed progression of the disease or the occurrence of death for any reason
5 secondary outcomes
Hematology and non hematology toxicity
Time frame: Throughout the treatment period，up to 6 months
CRR
Time frame: at the end of Cycle 6 (each cycle is 21 days)
ORR
Time frame: at the end of Cycle 6 (each cycle is 21 days)
EFS
Time frame: From date of randomization until the date of first documented event, such as progression of the disease or the occurrence of death for any reason, or receive other anti-tumor treatment, whichever came first, assessed up to 3 years
OS
Time frame: From date of patients sign informed consent until the date of death or the date of last follow-up time, whichever came first, assessed up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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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.
Junning Cao principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Parsaclisib and CHOP in people with PI3Kδ Inhibitor and Parsaclisib, run by Fudan University.
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 10 inclusion and 13 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 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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 Junning Cao (+86-21-64175590, cao_junning@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year EFS (time frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years). 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 14 Feb 2022.