Trial Title:
A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT ID:
NCT06508658
Condition:
Diffuse Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Rituximab
Gemcitabine
Oxaliplatin
Lenalidomide
Conditions: Keywords:
Epcoritamab
Lenalidomide
Rituximab
Gemcitabine
Oxaliplatin
Diffuse Large B-Cell Lymphoma
DLBCL
Epkinly
ABBV-GMAB-3013
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Epcoritamab
Description:
Subcutaneous Injection
Arm group label:
Arm A: Epcoritamab Plus Lenalidomide (E-Len)
Other name:
ABBV-GMAB-3013
Other name:
Epkinly
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Intravenous (IV) Infusion
Arm group label:
Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Oral Capsule
Arm group label:
Arm A: Epcoritamab Plus Lenalidomide (E-Len)
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
IV Infusion
Arm group label:
Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
IV Infusion
Arm group label:
Arm B: Rituximab Plus Gemcitabine and Oxaliplatin (R-GemOx)
Summary:
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood
cell responsible for fighting infections). This study will assess how safe and effective
epcoritamab plus lenalidomide (E-Len) is compared to rituximab plus gemcitabine and
oxaliplatin (R-GemOx) )in treating adult participants with relapsed or refractory (R/R)
Diffuse Large B-Cell Lymphoma (DLBCL). Adverse events and change in disease condition
will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study
doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives
a different treatment. Around 320 adult participants with R/R DLBCL will be enrolled in
approximately 165 sites across the world.
Participants in arm A will receive subcutaneous (SC) injections of epcoritamab plus oral
lenalidomide capsules (E-Len) for up to 12 cycles (each cycle is 28 days). Participants
"in arm B will receive intrav... (IV) infused R-GemOx for up to 4 cycles (each cycle is
28 days)
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital
or clinic. The effect of the treatment will be checked by medical assessments, blood
tests, checking for side effects and completing questionnaires.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Eastern Cooperative Oncology Group Performance status score of 0 to 2.
- Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented
in the most recent and representative pathology report, inclusive of the following
according to the World Health Organization (WHO) 2022 as per the protocol.
- Must have relapsed or refractory (R/R) disease and have been previously treated with
at least 1 line of systemic antineoplastic therapy including anti-CD20
mAb-containing combination chemotherapy since DLBCL diagnosis.
- . Participant must meet at least 1 of the following criteria:
- Failed prior autologous stem cell transplant (ASCT), defined as relapsed after
ASCT or been refractory to ASCT.
- Not be considered a candidate for ASCT due to age, performance status,
comorbidities and/or insufficient response to prior treatment, or have refused
ASCT.
- Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T)
meeting at least 1 of the following criteria:
- Unable to receive CAR-T therapy due to fitness and/or comorbidity.
- Lymphocyte apheresis failure.
- Unwilling to receive CAR-T therapy.
- Unable to receive CAR-T therapy due to financial, geographic, insurance,
access, and/or manufacturing constraints.
- Relapsed/progressed after having achieved at least a Partial Response (PR)
or Complete Response (CR) while on prior CAR-T therapy.
- Must have measurable disease.
- Life expectancy > 3 months on standard of care treatment at the time of enrolling in
the study
Exclusion Criteria:
- Current evidence of primary central nervous system (CNS) lymphoma or known CNS
involvement by lymphoma including leptomeningeal disease, at screening.
- History of prior treatment with a bispecific antibody targeting CD3 and CD20 or
prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or
gemcitabine and oxaliplatin (GemOx).
- Documented refractoriness to lenalidomide.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823
Address:
City:
Golden
Zip:
80401
Country:
United States
Status:
Recruiting
Facility:
Name:
New York Medical College /ID# 265799
Address:
City:
Valhalla
Zip:
10595
Country:
United States
Status:
Recruiting
Facility:
Name:
Thompson Cancer Survival Ctr /ID# 242149
Address:
City:
Knoxville
Zip:
37916
Country:
United States
Status:
Recruiting
Facility:
Name:
Canberra Hospital /ID# 265312
Address:
City:
Canberra
Zip:
2605
Country:
Australia
Status:
Recruiting
Facility:
Name:
Wollongong Hospital /ID# 244646
Address:
City:
Wollongong
Zip:
2500
Country:
Australia
Status:
Recruiting
Facility:
Name:
Monash Medical Centre /ID# 262783
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Phone:
03 9594 4044
Facility:
Name:
Royal Perth Hospital /ID# 243790
Address:
City:
Perth
Zip:
6000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Epicura - site d'Hornu /ID# 265148
Address:
City:
Boussu
Zip:
7301
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 242565
Address:
City:
Yvoir
Zip:
5530
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Universitair Ziekenhuis Leuven /ID# 246671
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
UMHAT Sveti Georgi /ID# 242905
Address:
City:
Plovdiv
Zip:
4002
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
UMHAT Sveti Ivan Rilski /ID# 242389
Address:
City:
Sofia
Zip:
1431
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
SHAT Hematologic Diseases /ID# 242708
Address:
City:
Sofia
Zip:
1797
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
UMHAT Sveta Marina /ID# 262761
Address:
City:
Varna
Zip:
9010
Country:
Bulgaria
Status:
Recruiting
Facility:
Name:
Klinicka bolnica Merkur /ID# 262619
Address:
City:
Zagreb
Zip:
10000
Country:
Croatia
Status:
Recruiting
Facility:
Name:
Klinicki Bolnicki Centar (KBC) Split /ID# 262618
Address:
City:
Split
Zip:
21000
Country:
Croatia
Status:
Recruiting
Facility:
Name:
CHRU Tours - Hopital Bretonneau /ID# 244580
Address:
City:
Tours CEDEX 9
Zip:
37044
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier D'Avignon /ID# 243072
Address:
City:
Avignon
Zip:
84000
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier de la Cote Basque /ID# 243065
Address:
City:
Bayonne
Zip:
64100
Country:
France
Status:
Recruiting
Facility:
Name:
Institut de cancérologie Strasbourg Europe (ICANS) /ID# 264068
Address:
City:
Strasbourg
Zip:
67200
Country:
France
Status:
Recruiting
Facility:
Name:
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 262901
Address:
City:
Gyor
Zip:
9024
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Debreceni Egyetem-Klinikai Kozpont /ID# 242451
Address:
City:
Debrecen
Zip:
4032
Country:
Hungary
Status:
Recruiting
Facility:
Name:
National Hospital Organization Shikoku Cancer Center /ID# 265977
Address:
City:
Matsuyama
Zip:
791-0280
Country:
Japan
Status:
Recruiting
Facility:
Name:
Fukushima Medical University Hospital /ID# 264667
Address:
City:
Fukushima-shi
Zip:
960-1295
Country:
Japan
Status:
Recruiting
Facility:
Name:
Sapporo Medical University Hospital /ID# 264928
Address:
City:
Sapporo
Zip:
060-8543
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kagoshima University Hospital /ID# 248259
Address:
City:
Kagoshima-shi
Zip:
890-8520
Country:
Japan
Status:
Recruiting
Facility:
Name:
Tokai University Hospital /ID# 265433
Address:
City:
Isehara
Zip:
259-1193
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kansai Medical University Hospital /ID# 266018
Address:
City:
Hirakata-shi
Zip:
573-1191
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kindai University Hospital /ID# 265474
Address:
City:
Osakasayama-shi
Zip:
589-8511
Country:
Japan
Status:
Recruiting
Facility:
Name:
University of Yamanashi Hospital /ID# 264671
Address:
City:
Chuo
Zip:
409-3898
Country:
Japan
Status:
Recruiting
Facility:
Name:
Inje University - Busan Paik Hospital /ID# 262842
Address:
City:
Busan
Zip:
47392
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital /ID# 242405
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Keimyung University Dongsan Hospital /ID# 262840
Address:
City:
Daegu
Zip:
42601
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Dong-A University Medical Center /ID# 262841
Address:
City:
Busan
Zip:
49201
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Chonnam National University Hwasun Hospital /ID# 262843
Address:
City:
Hwasun-gun
Zip:
58128
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital /ID# 242407
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center /ID# 242408
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242406
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Ulsan University Hospital /ID# 242956
Address:
City:
Ulsan
Zip:
44033
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Pratia MCM Krakow /ID# 262882
Address:
City:
Krakow
Zip:
30-727
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Site Coordinator
Phone:
+48 122954100
Facility:
Name:
Aidport sp z o.o. /ID# 262766
Address:
City:
Poznan
Zip:
60-175
Country:
Poland
Status:
Recruiting
Facility:
Name:
Hospital da Luz /ID# 262965
Address:
City:
Lisbon
Zip:
1500-650
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Unidade Local de Saude de Sao Joao, EPE /ID# 262962
Address:
City:
Porto
Zip:
4202-451
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Fundeni Clinical Institute /ID# 266734
Address:
City:
Bucharest
Zip:
022328
Country:
Romania
Status:
Recruiting
Facility:
Name:
Institutul Oncologic Prof Dr I Chiricuta /ID# 243753
Address:
City:
Cluj Napoca
Zip:
400015
Country:
Romania
Status:
Recruiting
Facility:
Name:
Institutul Regional de Oncologie /ID# 244367
Address:
City:
Jassi
Zip:
700483
Country:
Romania
Status:
Recruiting
Facility:
Name:
Spitalul Clinic Coltea /ID# 243694
Address:
City:
Bucharest
Zip:
030171
Country:
Romania
Status:
Recruiting
Facility:
Name:
Institute for Oncology and Radiology of Serbia /ID# 263055
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
University Clinical Center Nis /ID# 263701
Address:
City:
Niš
Zip:
18300
Country:
Serbia
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital /ID# 243300
Address:
City:
Taipei City
Zip:
100
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
China Medical University Hospital /ID# 242931
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taichung Veterans General Hospital /ID# 242937
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Cheng Kung University Hospital /ID# 243301
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Start date:
August 13, 2024
Completion date:
January 17, 2028
Lead sponsor:
Agency:
Genmab
Agency class:
Industry
Source:
Genmab
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06508658
https://www.abbvieclinicaltrials.com/study/?id=M22-128
