Phase
Condition
Lymphoma
Leukemia
Chronic Lymphocytic Leukemia
Treatment
JNJ-80948543
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chroniclymphocytic leukemia (CLL) requiring therapy.
All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment.
B-cell NHL as defined per the 2016 world health organization (WHO) classification. In addition, the following disease-specific criteria outlined below must be met:
If diffuse large B-cell lymphoma (DLBCL) or other high-Grade B-cell lymphoma: Received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent or deemed not eligible or fit for an alternative 2nd line therapy. Participants may be eligible if relapsing after chimeric antigen receptors (CAR-T) cell treatment or while waiting for a CAR-T cell treatment.
If transformed lymphoma from low Grade B-cell malignancies: Received or not a candidate for an approved first-line regimen for DLBCL and received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent.
If follicular lymphoma (FL) (all grades): Previously treated with a minimum of 2 prior lines of systemic therapy, with at least one prior line containing an anti-CD20 antibody.
If mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) (including nodal, extranodal/MALT, and splenic MZL subtypes): Previously treated with at least 2 lines of systemic therapy. H.pylori-positive gastric MALT lymphoma must have failed prior H. pylori eradication therapy as one of their prior lines .
Waldenstrom macroglobulinemia (WM): Previously treated with at least 1 line of systemic therapy.
small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL/SLL): Relapsed or refractory with at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor (BTK) inhibitor or a BCL2 inhibitor, if eligible. In addition for part B Participants must have measurable disease as defined by the appropriate disease response criteria
Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
Cardiac parameters within the following range: corrected QT interval (QTc intervalscorrected using Fridericia's formula [QTcF]) less than or equal to (<=) 480milliseconds based on the average of triplicate assessments performed no more than 5 (plus minus [+-] 3) minutes apart
A female participant of childbearing potential must have a negative highly sensitiveserum pregnancy test (beta- human chorionic gonadotropin) at screening and mustagree to further serum or urine pregnancy tests prior to the first dose, during thestudy and until 3 months after the last dose of study treatment
A female participant must agree not to be pregnant, breastfeeding, or planning tobecome pregnant while enrolled in this study or within 3 months after the last doseof study treatment
Exclusion
Exclusion Criteria:
Known active central nervous system (CNS) involvement; Lymphoma with CNS involvementmay be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts ifapproved by the study evaluation team (SET)
Prior solid-organ transplantation
Autoimmune or inflammatory disease requiring systemic steroids or otherimmunosuppressive agents (example, methotrexate or tacrolimus) within 1 year priorto first dose of study drug
Toxicity from prior anticancer therapy has not resolved to baseline levels or toGrade <= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathiesthat are stable on hormone replacement, which may be Grade 2)
Clinically significant pulmonary compromise, particularly the need for supplementaloxygen use to maintain adequate oxygenation
Study Design
Connect with a study center
Macquarie University Hospital
Macquarie University, 2109
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, 3004
AustraliaActive - Recruiting
Linear Clinical Research Ltd
Nedlands, 6009
AustraliaActive - Recruiting
Scientia Clinical Research
Randwick, 2031
AustraliaActive - Recruiting
Chongqing University Cancer Hospital
Chongqing, 400044
ChinaActive - Recruiting
Sun Yat Sen University Cancer Center
Guangzhou, 510060
ChinaActive - Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, 510060
ChinaActive - Recruiting
Tianjin cancer hospital
Tianjin, 300060
ChinaActive - Recruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430030
ChinaActive - Recruiting
Rigshospitalet
Copenhagen, 2100
DenmarkActive - Recruiting
Rigshospitalet
København, 2100
DenmarkSite Not Available
Odense University Hospital
Odense, 5000
DenmarkActive - Recruiting
CHRU de Lille - Hopital Claude Huriez
Lille Cedex, 59037
FranceActive - Recruiting
CHRU de Lille Hopital Claude Huriez
Lille Cedex, 59037
FranceActive - Recruiting
Hopital Saint Eloi
Montpellier Cedex 5, 34285
FranceSite Not Available
Institut Curie
Paris, 75005
FranceActive - Recruiting
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, 67033
FranceActive - Recruiting
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse Cedex 9, 31059
FranceActive - Recruiting
Gustave Roussy
Villejuif, 94800
FranceSite Not Available
Carmel Medical Center
Haifa, 34362
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem, 9112001
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
IsraelActive - Recruiting
National Cancer Center Hospital East
Kashiwa, 277 8577
JapanActive - Recruiting
Aichi Cancer Center
Nagoya Shi, 464 8681
JapanActive - Recruiting
Aichi Cancer Center Hospital
Nagoya Shi, 464 8681
JapanSite Not Available
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550
JapanActive - Recruiting
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
Gdansk, 80 952
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz
Gdansk, 80-214
PolandActive - Recruiting
Aidport Sp z o o
Skorzewo, 60-185
PolandActive - Recruiting
Centrum Medyczne Pratia Poznan
Skorzewo, 60 185
PolandActive - Recruiting
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesCompleted
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Texas Transplant Institute
San Antonio, Texas 78229
United StatesActive - Recruiting
Seattle Cancer Care Alliance
Seattle, Washington 98109
United StatesActive - Recruiting
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