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Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL

10 februari 2022 bijgewerkt door: Junning Cao, MD, Fudan University

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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

30

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 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.
  • 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).

Exclusion Criteria:

  • 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.
  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: PI3Kδ inhibitor Parsaclisib plus CHOP

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.
Geneesmiddel: Parsaclisib

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.

Andere namen:
  • IBI376
Geneesmiddel: CHOP
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
Andere namen:
  • Cyclophosphamide, doxorubicin, vincristine and prednison

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
3-year EFS
Tijdsspanne: 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
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hematologische en niet-hematologische toxiciteit
Tijdsspanne: Gedurende de behandelingsperiode, tot 6 maanden
aantal deelnemers met behandelingsgerelateerde bijwerkingen zoals beoordeeld door CTCAE v5.0
Gedurende de behandelingsperiode, tot 6 maanden
CRR
Tijdsspanne: at the end of Cycle 6 (each cycle is 21 days)
the ratio of numbers of patients with complete response to all the participants receiving treatment
at the end of Cycle 6 (each cycle is 21 days)
ORR
Tijdsspanne: at the end of Cycle 6 (each cycle is 21 days)
the ratio of numbers of patients with complete response and partial response to all the participants receiving treatment
at the end of Cycle 6 (each cycle is 21 days)
EFS
Tijdsspanne: 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
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
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
Tijdsspanne: 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
time between the date of patients sign informed consent and the date of death or the date of last follow-up time
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fudan University

Onderzoekers

  • Hoofdonderzoeker: Junning Cao, Fudan University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 maart 2022

Primaire voltooiing (Verwacht)

1 maart 2025

Studie voltooiing (Verwacht)

1 december 2025

Studieregistratiedata

Eerst ingediend

28 januari 2022

Eerst ingediend dat voldeed aan de QC-criteria

10 februari 2022

Eerst geplaatst (Werkelijk)

14 februari 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 februari 2022

Laatste update ingediend die voldeed aan QC-criteria

10 februari 2022

Laatst geverifieerd

1 februari 2022

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PTCL-2022-01

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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