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Imfinzi NSCLC
Imfinzi NSCLC


A Study of JNJ-67856633 in Participants With Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)



April 2019

Letztes Update:


Indikation (Clinical Trials):
Lymphoma, Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Leukemia, Lymphoid


Erwachsene (18+)

Phase 1

Janssen Research & Development, LLC



Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC


Studienlocations (3 von 36)

Georg-August-Universitaet Goettingen
37075 Göttingen
GermanyNoch nicht rekrutierend» Google-Maps
Kinderonkologisches Zentrum am Universitätsklinikum Münster
Albert-Schweitzer-Campus 1
48149 Münster
DeutschlandNoch nicht rekrutierend» Google-Maps
Leberkrebszentrum Universitätsklinikum Ulm
Albert-Einstein-Allee 23
89081 Ulm
DeutschlandNoch nicht rekrutierend» Google-Maps
University of Nebraska Medical Center
68198 Omaha
United StatesNoch nicht rekrutierend» Google-Maps
Weill Cornell Medicine
10021 New York
United StatesRekrutierend» Google-Maps
Icahn School of Medicine at Mount Sinai
10029 New York
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
Peter MacCallum Cancer Centre
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Linear Clinical Research Ltd
6009 Nedlands
AustraliaRekrutierend» Google-Maps
Scientia Clinical Research
2031 Randwick
AustraliaRekrutierend» Google-Maps
CHU de Nantes hôtel-Dieu
44093 Nantes Cedex 1
FranceNoch nicht rekrutierend» Google-Maps
Groupe Hospitalier Pitie Salpetriere
75013 Paris
FranceRekrutierend» Google-Maps
Centre hospitalier Lyon-Sud
69495 Pierre Benite
FranceRekrutierend» Google-Maps
Institut Universitaire du Cancer Toulouse - Oncopole
31059 Toulouse
FranceNoch nicht rekrutierend» Google-Maps
Institut Gustave Roussy
94805 VILLEJUIF Cedex
FranceRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Center
64239 Tel Aviv
IsraelRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Chuo-Ku
JapanRekrutierend» Google-Maps
The Cancer Institute Hospital of JFCR
135-8550 Koto-Ku
JapanRekrutierend» Google-Maps
National Hospital Organization Nagoya Medical Center
460-0001 Nagoya
JapanRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Hosp. Univ. Germans Trias I Pujol
8916 Badalona, Barcelona
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario Salamanca
37007 Salamanca
SpainRekrutierend» Google-Maps
Hosp. Univ. Marques de Valdecilla
39008 Santander
SpainRekrutierend» Google-Maps
Alle anzeigen


Detailed Description:

Non-Hodgkin lymphoma (NHL) represents a diverse set of diseases. Among them diffuse large

B-cell lymphoma (DLBCL) represents the most common subtype of NHL, accounting for 30 percent

(%) to 40% of all newly diagnosed cases. Mucosa-associated lymphoid tissue lymphoma

translocation protein 1 (MALT1) is a key mediator of the nuclear factor

kappa-light-chain-enhancer of activated B cells (NF-kappaB) signaling pathway and has been

shown to play a critical role in different types of lymphoma, including activated B cell-like

(ABC) subtype of diffuse large B-cell lymphoma (DLBCL). JNJ-67856633 is a MALT1 inhibitor and

will be administered orally. The study will evaluate the following: Dose Escalation (Part 1):

One or more recommended Phase 2 dose (RP2Ds) of JNJ-67856633. Cohort Expansion (Part 2):

JNJ-67856633 is well tolerated and achieves antitumor responses at the RP2D. The study

consists of screening phase (less than or equal to 28 days before first dose), treatment

phase (from Cycle 1 Day 1 till end of treatment visit [within 30 (+7) days after the last

dose]) and post-treatment phase. A prescreening period may also apply to participants in

select cohorts in Part 2. The total study duration will be approximately 3 years. Efficacy

assessments will include radiographic image assessments, positron emission tomography scan,

bone marrow assessment, endoscopy or colonoscopy etc. Safety will be monitored throughout the



Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

- Cardiac parameters within the following range: corrected QT interval (QTc intervals

corrected using Fridericia's formula [QTcF]) less than or equal to (<=)480

milliseconds based on the average of triplicate assessments performed no more than 5

minutes apart (plus minus [+-]3 minutes)

- Women of childbearing potential must have a negative highly sensitive serum (Beta

human chorionic gonadotropin) at screening and prior to the first dose of study drug,

and until 30 days after the last dose

- In addition to the user-independent, highly effective method of contraception, a male

or female condom with or without spermicide is required, example, condom with

spermicidal foam/gel/film/cream/suppository. Male condom and female condom should not

be used together (due to risk of failure with friction)

- Men must wear a condom when engaging in any activity that allows for passage of

ejaculate to another person. Male participants should also be advised of the benefit

for a female partner to use a highly effective method of contraception as condom may

break or leak

Exclusion Criteria:

- Known active central nervous system (CNS) involvement for dose escalation and specific

expansion cohorts as determined by the study evaluation team (SET)

- Prior solid-organ transplantation

- Either of the following: a) Received an autologous stem cell transplant less than or

equal to (<=)3 months before the first dose of study drug. b) Prior treatment with

allogenic stem cell transplant <=6 months before the first dose of study drug, has

evidence of graft versus host disease, or requires immunosuppressant therapy

- 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

drug. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in

situ of the cervix, or malignancy which in the opinion of the investigator, with

concurrence with the sponsor's medical monitor, is considered cured with minimal risk

of recurrence within 1 year before the first dose of study drug. Concomitant

malignancies that are unlikely to progress and/or preclude evaluation of study

endpoints may be allowed after discussion with the Study Responsible Physician

- Prior treatment with a mucosa-associated lymphoid tissue lymphoma translocation

protein 1 (MALT1) inhibitor


Primary outcome:

1. Part 1: Dose-Limiting Toxicity (DLT) (Time Frame - Approximately 21 days):
The DLTs are based on drug related adverse events and defined as any of the following events: any toxicity that would require discontinuation of treatment; and/or hematological / non-hematological toxicity of Grade 3 or higher.

2. Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Time Frame - Approximately 2 years):
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Secondary outcome:

1. JNJ-67856633 Plasma Concentrations (Time Frame - Approximately 2 years):
Concentration assessment will be done to evaluate the effect of JNJ-67856633.

2. Part 1 and Part 2: Change in Gene Expression After Treatment with JNJ-67856633 (Time Frame - Approximately 2 years):
Change in gene expression after treatment with JNJ-67856633 will be analyzed.

3. Part 1 and Part 2: Overall Response Rate (ORR) (Time Frame - Approximately 2 years):
ORR is defined as the percentage of participants who have a partial response (PR) and complete response (CR) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL), non-Hodgkin lymphoma and Waldenstrom macroglobulinemia response criteria.

4. Part 1 and Part 2: Complete Response Rate (Time Frame - Approximately 2 years):
Complete response rate is defined as the percentage of participants who achieve a best response of CR according to the iwCLL, non-Hodgkin lymphoma and Waldenstrom macroglobulinemia response criteria.

5. Part 1 and Part 2: Time to Response (TTR) (Time Frame - Approximately 2 years):
TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR.

6. Part 1 and Part 2: Duration of Response (DoR) (Time Frame - Approximately 2 years):
DoR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of first documented evidence of disease progression or death, whichever comes first.


  • Experimental: Part 1 (Dose Escalation): JNJ-67856633
    Participants will receive JNJ-67856633 until disease progression, intolerable toxicity, withdrawal of consent, or the investigator or sponsor decision. Subsequent dose levels will be assigned by the sponsor using an adaptive dose escalation strategy based on all available safety, pharmacokinetic (PK), and biomarker data.
  • Experimental: Part 2 (Cohort Expansion): JNJ-67856633
    Participants will receive JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1.

Geprüfte Regime

  • JNJ-67856633:
    JNJ-67856633 capsule will be administered orally.

Quelle: ClinicalTrials.gov

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