Skojarzenie orelabrutynibu i obinutuzumabu w leczeniu nieleczonych chłoniaków strefy brzeżnej
Orelabrutynib w skojarzeniu z obinutuzumabem jako leczenie pierwszego rzutu w leczeniu chłoniaka strefy brzeżnej: prospektywne badanie przeprowadzone na jednej grupie
This is a prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with obinutuzumab a in untreated marginal zone lymphoma. It is planned to recruit 45 patients. The primary endpoint is the complete remission rate at 12 months.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Marginal zone lymphomas (MZL) are a type of lymphoma that originates from the marginal zone tissue of the lymphoid follicles (Mucosa-associated lymphoid tissue, MALT), and include three subtypes: MALT lymphoma, nodal MZL, and splenic MZL. For patients with marginal zone lymphoma who have indications for systemic anti-tumor treatment, therapeutic options include rituximab monotherapy or more intensive immunochemotherapy regimens in combination with bendamustine, chlorambucil, CHOP regimen (cyclophosphamide, vincristine, doxorubicin, prednisone), etc.
This is a prospective, phase II, single-arm clinical study to initially explore the efficacy and safety of Orelabrutinib combined with obinutuzumab in patients with previously untreated marginal zone lymphoma. The patients will be treated with 6 cycles of OG regimen. Patients with CR/PR after 6 cycles of OG treatment will be treated with 18 cycles of single-agent orelabrutinib regimen.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Tianjin, Chiny, 300020
- China Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
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• Age ≥18 years, gender unrestricted;
- Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL;
- MZL that has progressed, recurred, or is unsuitable for local treatment after previous local therapy (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, hepatitis C treatment);
- ECOG performance status score of 0-2.
- Major organ functions meet the following criteria: a) Complete blood count: Absolute neutrophil count ≥1.5×10^9/L, platelets ≥75×10^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, absolute neutrophil count ≥1.0×10^9/L, platelets ≥50×10^9/L, hemoglobin ≥50g/L; b) Blood biochemistry: Total bilirubin ≤1.5 times the upper limit of normal (ULN), AST or ALT ≤2 times ULN; serum creatinine ≤1.5 times ULN; serum amylase ≤ULN; c) Coagulation function: International normalized ratio (INR) ≤1.5 times ULN.
- Life expectancy ≥3 months;
- Voluntarily sign a written informed consent form before the trial screening.
Exclusion Criteria:
- Currently or previously having other malignant tumors, unless radical treatment has been performed and there is evidence of no recurrence or metastasis within the last 5 years;
- Lymphoma involving the central nervous system or transforming into a higher grade;
- Having uncontrollable or significant cardiovascular diseases, including: a) New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction within 6 months before the first administration of the study drug, or arrhythmias requiring treatment at the time of screening, with a left ventricular ejection fraction (LVEF) <50%; b) Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); c) A history of clinically significant QTc interval prolongation, or a QTc interval >470ms in females and >450ms in males during the screening period; d) Subjects with symptomatic or medication-requiring coronary artery heart disease; e) Subjects with difficult-to-control hypertension (despite lifestyle improvements and the use of reasonable, tolerable, and adequate doses of one or three or more antihypertensive drugs [including diuretics] for more than 1 month, blood pressure is still not at the standard, or it is only effectively controlled when taking four or more antihypertensive drugs).
- Active bleeding within 2 months before screening, or currently taking anticoagulant drugs, or the investigator believes there is a definite bleeding tendency;
- Active infection or uncontrolled HBV (positive for HBsAg and/or HBcAb with positive HBV DNA titer), positive for HCV Ab, HIV/AIDS, or other serious infectious diseases.
- Any other conditions deemed unsuitable for participation in this trial by the investigator.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: OG
6 cycles of OG regimen. Patients with CR/PR after 6 cycles of OG treatment will be treated with 18 cycles of single-agent orelabrutinib regimen. Orelabrutinib 150mg QD |
Orelabrutinib and obinutuzumab 6cycles ;orelabrutinib 150mg |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
the complete response rate
Ramy czasowe: At 12 months.
|
CRR is defined as the proportion of patients with a response of CR |
At 12 months.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
CRR
Ramy czasowe: At the end of induction therapy(6cycles). 28days/cycle
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CRR is defined as the proportion of patients with a best response of CR |
At the end of induction therapy(6cycles). 28days/cycle
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ORR
Ramy czasowe: At 12 months.
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The ORR is defined as the proportion of patients with a response of CR |
At 12 months.
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BOR
Ramy czasowe: At 12 months.
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The BOR is defined as the proportion of patients with a best response of CR or PR |
At 12 months.
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2 years progression-free survival
Ramy czasowe: From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
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Progression free survival (PFS) is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment. |
From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
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2 years overall survival
Ramy czasowe: From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years]
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Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date. |
From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years]
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TTR
Ramy czasowe: Up to 2 years
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TTR is defined as the time from registration to the first response. |
Up to 2 years
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Duration of Response (DOR)
Ramy czasowe: Up to 2 years
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Duration of response as defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date. |
Up to 2 years
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The occurrence of adverse events and serious adverse events
Ramy czasowe: One month after discontinuation of treatment
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Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5. |
One month after discontinuation of treatment
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Współpracownicy i badacze
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory
- Choroby układu odpornościowego
- Nowotwory według typu histologicznego
- Choroby limfatyczne
- Zaburzenia limfoproliferacyjne
- Zaburzenia immunoproliferacyjne
- Chłoniak nieziarniczy
- Chłoniak z komórek B
- Chłoniak
- Choroby hemowe i limfatyczne
- Chłoniak, komórki B, strefa brzeżna
- Obinutuzumab
- Orelabrutynib
Inne numery identyfikacyjne badania
- IIT2024013
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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