En studie av JNJ-88998377 for residiverende/refraktær B-celle non-Hodgkins lymfom
En fase 1, første-i-menneske, doseeskaleringsstudie av JNJ-88998377 hos deltakere med residiverende/refraktær B-celle non-Hodgkins lymfom (NHL)
The main purpose of this study is to characterize safety and to determine the recommended phase 2 dose (RP2D) for JNJ-88998377 (Part A: Dose Escalation), to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Bologna, Italia, 40138
- A O U Sant Orsola Malpighi
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Chūōku, Japan, 104 0045
- National Cancer Center Hospital
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Kashiwa, Japan, 277-8577
- National Cancer Center Hospital East
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Tokyo, Japan, 135 8550
- The Cancer Institute Hospital of JFCR
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Beijing, Kina, 100142
- Beijing Cancer Hospital
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Guangzhou, Kina, 510062
- Sun Yat Sen University Cancer Center
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Hangzhou, Kina, 310002
- The First Affiliated Hospital Zhejiang University College of Medicine
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Shanghai, Kina, 200032
- Fudan University Shanghai Cancer Center
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Tianjin, Kina, 300181
- Tianjin Medical University Cancer Institute and Hospital
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Katowice, Polen, 40 519
- Pratia Onkologia Katowice
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Kielce, Polen, 25-734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku
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Skorzewo, Polen, 60-185
- Aidport Sp z o o
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Seoul, Sør -Korea, 03080
- Seoul National University Hospital
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Seoul, Sør -Korea, 06351
- Samsung Medical Center
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Taipei, Taiwan, 10043
- National Taiwan University Hospital
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Taoyuan, Taiwan, 33382
- Linkou Chang Gung Memorial Hospital
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Ankara, Tyrkia (Türkiye), 06200
- SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi
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Ankara, Tyrkia (Türkiye), 06620
- Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
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Istanbul, Tyrkia (Türkiye), 34010
- Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Participants have histologically or cytologically confirmed B-cell non-Hodgkin's Lymphoma (NHL) according to the 2022 World Health Organization (WHO) classification with relapsed or refractory disease
- Participants have measurable disease or meet all requirements for adequate response assessment as defined by the appropriate disease response criteria at screening
- Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants have a life expectancy of greater than or equal to (>=) 12 weeks
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol
Exclusion Criteria:
- Participant with active or prior history of B-cell NHL involving the central nervous system (CNS) and leptomeningeal involvement
- History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study treatment.
- For Part A and B: Participant having known allergies, hypersensitivity, or intolerance to the excipients of JNJ-88998377
- Participant had major surgery or had significant traumatic injury within 30 days before first dose of study treatment or has not recovered from surgery and must not have major surgery planned during the time the participant is receiving study treatment
- Participant received an autologous stem cell transplant less than or equal to (<=) 3 months before the first dose of study treatment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Part A: Dose Escalation
Participants will receive JNJ-88998377 at a selected starting dose. Subsequent dose levels and schedules will be selected based on the review of all available data to establish recommended Phase 2 dose (RP2D). |
JNJ-88998377 will be administered. |
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Eksperimentell: Part B: Dose Expansion
Participants will receive JNJ-88998377 at RP2D determined in Part A. Additional expansion cohort(s) may be added with a lower RP2D(s), or different dose schedule(s) based on all available data. |
JNJ-88998377 will be administered. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Parts A and B: Number of Participants with Adverse Events (AEs)
Tidsramme: Upto 3 years 4 months
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. |
Upto 3 years 4 months
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Part A: Number of Participants with Dose Limiting Toxicity (DLTs)
Tidsramme: Cycle 1 (21 days)
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Number of participant with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological or hematological toxicity. |
Cycle 1 (21 days)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Plasma Concentration of JNJ-88998377
Tidsramme: Up to first 12 weeks
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Plasma concentration of oral dose of JNJ-88998377 will be assessed. |
Up to first 12 weeks
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Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377
Tidsramme: Up to first 12 weeks
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Area under the plasma concentration versus time curve during a dosing interval (τ) at steady-state concentration of JNJ-88998377 will be reported. |
Up to first 12 weeks
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Maximum Plasma Concentration (Cmax) of JNJ-88998377
Tidsramme: Up to first 12 weeks
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Cmax of JNJ-88998377 will be reported. |
Up to first 12 weeks
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Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377
Tidsramme: Up to first 12 weeks
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Cmin of JNJ-88998377 will be reported. |
Up to first 12 weeks
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Percentage of Participants With Overall Response (OR)
Tidsramme: Up to 3 years 4 months
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OR is defined as the percentage of participants who have a best response of partial response (PR) or better per investigator assessment according to disease-specific response criteria. |
Up to 3 years 4 months
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Time to Response (TTR)
Tidsramme: From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
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TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better per investigator assessment according to disease-specific response criteria. |
From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
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Duration of Response (DOR)
Tidsramme: From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)
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DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death. |
From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 88998377LYM1001
- 88998377LYM1001 (Annen identifikator: Janssen Research & Development, LLC)
- 2023-509258-71-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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