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A Study of OLR in First-line Treatment of Mantle Cell Lymphoma

A Prospective Phase II Clinical Study of Orelabrutinib in Combination With Lenalidomide and Rituximab (OLR) in First-line Treatment of Mantle Cell Lymphoma

This is a single-arm, multicenter, open label phase II clinical study to evaluate the efficacy and safety of OLR in the treatment of initially treated mantle cell lymphoma.

Studieoversigt

Detaljeret beskrivelse

Patients initially treated with mantle cell lymphoma were screened for OLR regimen according to study admission criteria. The study will accept up to 24 cycles of treatment until disease progression or intolerable toxicity occurs and subjects voluntarily withdraw informed consent. Patients undergoing hematopoietic stem cell transplantation after complete remission may begin stem cell collection after induction therapy for at least 6 months. Twenty-nine patients are expected to be enrolled

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

29

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Tianjin
      • Tianjin, Tianjin, Kina, 300181
        • Rekruttering
        • Tianjin Medical University Cancer Insititute & Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Histopathologically confirmed mantle cell lymphoma with chromosomal translocation. All subjects must provide adequate archived or fresh tumor tissue samples for immunohistochemistry (IHC) testing.
  2. Age 18-70, both male and female.
  3. No previous systemic treatment for lymphoma.
  4. Have at least one measurable lesion. Measurable disease was defined as measurable tumor masses ≥1.5 cm in one or both dimensions and measurable spleen lesions.
  5. Eastern Oncology Collaboration group physical status score was 0-2.
  6. Adequate hematological function
  7. Life expectancy >3 months.
  8. Have the ability to provide written informed consent and understand and comply with study requirements.
  9. Ability to adhere to research visit schedules and other protocol requirements

Exclusion Criteria:

  1. Histology conformed blastolytic mantle cell lymphoma and polymorphic mantle cell lymphoma.
  2. Patients with current or suspected central nervous system involvement and history of this disease
  3. Received Bruton's tyrosine kinase inhibitor treatment
  4. Receive lenalidomide treatment
  5. Received other anti-tumor treatments
  6. Major surgery within 4 weeks prior to screening.
  7. Have a history of other active malignant diseases within 2 years prior to study entry,
  8. Systemic fungal, bacterial or viral infection with uncontrolled activity
  9. The following serological states are known for human immunodeficiency virus (HIV) infection or suggest the presence of active hepatitis B or C virus infection
  10. Clinically serious cardiovascular disease
  11. A history of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von willebrand disease, or A history of spontaneous bleeding requiring blood transfusion or other medical intervention.
  12. A history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months.
  13. A history of major cerebrovascular disease/event, including stroke or intracranial hemorrhage, in the 6 months prior to first administration of the study drug.
  14. Anticoagulant therapy with warfarin or an equivalent vitamin K antagonist or anticoagulant therapy is required within 7 days of initial use of the study drug.
  15. Pregnant or lactating women
  16. Hypersensitivity to any study drug
  17. The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator considers to be likely to affect the safety of the subject or cause risk

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Orelabtutinib in combination of rituximab and lenalidomide(OLR) Arm
Induction phase of mantle cell L lymphoma: Orelabrutinib: 150mg QD D1-28; Lenalidomide: Cycle 1: 15mg QD D1-21, if no dose-limiting toxicity occurred in Cycle 1, cycle 2-6: 20mg QD D1-21; Cycle 1: 375 mg/m2 d1, 8,15,22; Cycle 3, 5: 375 mg/m2 D1 Maintenance treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: cycle 7-24: 15mg QD D1-21; Cycle 7, 9, 11, 13, 15, 17, 19, 21, 23: 375 mg/m2 D1
Induction treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: Cycle 1: 15mg QD D1-21, if no dose-limiting toxicity occurred in Cycle 1, cycle 2-6: 20mg QD D1-21; Cycle 1: 375 mg/m2 d1, 8,15,22; Cycle 3, 5: 375 mg/m2 D1 Maintenance treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: cycle 7-24: 15mg QD D1-21; Cycle 7, 9, 11, 13, 15, 17, 19, 21, 23: 375 mg/m2 D1. 28 days for a cycle.
Andre navne:
  • OLR Arm

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete Response Rate
Tidsramme: At the end of Cycle 6(each cycle is 28 days)
The proportion of patients receiving the treatment with complete remission
At the end of Cycle 6(each cycle is 28 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate
Tidsramme: Approximately 2 years
The proportion of patients with response of PR and CR.
Approximately 2 years
Time to Response
Tidsramme: Approximately 1 year
Measured from the date of initiation of treatment to the time of response
Approximately 1 year
The Progression Free Survival Rate in 2 Years
Tidsramme: 2 Years
The proportion of patients who didn't achieve disease progression or death in 2 years.
2 Years
The Overall Survival Rate in 2 Years
Tidsramme: 2 Years
The proportion of patients who didn't achieve death in 2 years
2 Years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Huilai Zhang, PHD, Director of Hematology Department

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. september 2021

Primær færdiggørelse (Forventet)

15. oktober 2022

Studieafslutning (Forventet)

15. oktober 2023

Datoer for studieregistrering

Først indsendt

30. september 2021

Først indsendt, der opfyldte QC-kriterier

12. oktober 2021

Først opslået (Faktiske)

13. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

No individual patient data will be shared with other researchers

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mantelcellelymfom

Kliniske forsøg med Orelabrutinib in in combination of rituximab and lenalidomide(OLR)

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Abonner