A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

April 8, 2024 updated by: AbbVie

Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 394 adult participants with NHL will be enrolled in 100 sites globally.

In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28-day or 21 day cycles dependent on the arm in combination with the anti-neoplastic agents described below:

1: Oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in participants with newly diagnosed treatment-naïve DLBCL; 4: Oral CC-99282 in participants with R/R DLBCL; 5: Oral CC-99282 in participants with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in participants with R/R mantle cell lymphoma (MCL); 6B: Oral ibrutinib, and oral venetoclax in participants with R/R MCL; 7: Oral ibrutinib, and oral venetoclax in participants with newly diagnosed treatment-naïve MCL.

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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

394

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Brno, Czechia, 613 00
        • Recruiting
        • Fakultni nemocnice Brno /ID# 242683
      • Hradec Kralove, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove /ID# 241722
      • Ostrava, Czechia, 708 52
        • Recruiting
        • Fakultni Nemocnice Ostrava /ID# 242684
      • Praha, Czechia, 128 08
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze /ID# 242685
  • Denmark
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital - Skejby /ID# 242670
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Recruiting
        • Aalborg University Hospital /ID# 242734
  • France
      • Créteil, France, 94010
        • Recruiting
        • Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 242337
      • Paris, France, 75013
        • Recruiting
        • Hopital Pitie Salpetriere /ID# 242343
      • Toulouse Cedex 9, France, 31059
        • Recruiting
        • IUCT Oncopole /ID# 242340
    • Auvergne-Rhone-Alpes
      • Clermont, Auvergne-Rhone-Alpes, France, 63100
        • Recruiting
        • CHU Clermont-Ferrand /ID# 242344
    • Bretagne
      • Rennes, Bretagne, France, 35000
        • Recruiting
        • CHU de Rennes - PONTCHAILLOU /ID# 242339
    • Ile-de-France
      • Paris, Ile-de-France, France, 75010
        • Recruiting
        • Institut de Recherche Saint Louis - Hopital St Louis /ID# 242336
    • Meurthe-et-Moselle
      • Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
        • Recruiting
        • CHRU Nancy - Hopitaux de Brabois /ID# 242342
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • CHRU Lille - Hopital Claude Huriez /ID# 242335
    • Pays-de-la-Loire
      • Nantes, Pays-de-la-Loire, France, 44000
        • Recruiting
        • CHU de Nantes, Hotel Dieu -HME /ID# 242345
    • Rhone
      • Pierre Benite CEDEX, Rhone, France, 69495
        • Recruiting
        • HCL - Hopital Lyon Sud /ID# 242349
  • Germany
      • Marburg, Germany, 35043
        • Recruiting
        • Universitaetsklinikum Giessen und Marburg /ID# 245308
      • Regensburg, Germany, 93042
        • Recruiting
        • Universitaetsklinikum Regensburg /ID# 244517
      • Wuerzburg, Germany, 97080
        • Recruiting
        • Universitaetsklinikum Wuerzburg /ID# 245453
    • Baden-Wuerttemberg
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm /ID# 244265
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Universitaetsklinikum Leipzig /ID# 245513
  • Hungary
      • Budapest, Hungary, 1085
        • Recruiting
        • Semmelweis Egyetem /ID# 242454
      • Budapest, Hungary, 1122
        • Recruiting
        • Orszagos Onkologiai Intezet /ID# 242458
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem-Klinikai Kozpont /ID# 242450
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • Recruiting
        • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935
  • Israel
    • H_efa
      • Haifa, H_efa, Israel, 4941492
        • Recruiting
        • Rabin Medical Center /ID# 243014
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5265601
        • Recruiting
        • The Chaim Sheba Medical Center /ID# 243010
      • Tel Aviv, Tel-Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center /ID# 243012
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91120
        • Recruiting
        • Hadassah Medical Center-Hebrew University /ID# 243013
  • Japan
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital /ID# 248999
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital /ID# 248997
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital /ID# 248995
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital /ID# 242402
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center /ID# 242401
    • Gyeonggido
      • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital /ID# 242404
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center /ID# 242400
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242403
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Recruiting
        • Vrije Universiteit Medisch Centrum /ID# 243319
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Universitair Medisch Centrum Groningen /ID# 243318
      • Leiden, Netherlands, 2333 ZA
        • Recruiting
        • Leids Universitair Medisch Centrum /ID# 243316
      • Maastricht, Netherlands, 6229 HX
        • Recruiting
        • Maastricht Universitair Medisch Centrum /ID# 243317
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Completed
        • Duplicate_Erasmus Medisch Centrum /ID# 243315
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron /ID# 243260
      • Madrid, Spain, 28027
        • Recruiting
        • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre /ID# 243262
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 243264
      • Salamanca, Spain, 37711
        • Recruiting
        • Hospital Universitario de Salamanca /ID# 243368
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio /ID# 243267
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia /ID# 243269
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265
      • Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 243261
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra - Pamplona /ID# 245031
  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital /ID# 242893
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital /ID# 242894
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hosp /ID# 242892
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719-1478
        • Recruiting
        • University of Arizona Cancer Center - North Campus /ID# 242219
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University /ID# 242089
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Christiana Care Health Service /ID# 242301
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital /ID# 246748
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Recruiting
        • Emory University /ID# 242153
    • Maryland
      • Baltimore, Maryland, United States, 21201-1544
        • Recruiting
        • University of Maryland School of Medicine /ID# 242218
    • Missouri
      • Kansas City, Missouri, United States, 64114-4859
        • Recruiting
        • Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health - Monter Cancer Center /ID# 245435
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai /ID# 242123
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Presbyterian Medical Center /ID# 242148
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University Brody School of Medicine /ID# 242506
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Forsyth Medical Center /ID# 242198
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-4414
        • Recruiting
        • Thomas Jefferson University /ID# 242077
      • Philadelphia, Pennsylvania, United States, 19111
        • Completed
        • Fox Chase Cancer Center /ID# 242106
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Recruiting
        • Thompson Cancer Survival Ctr /ID# 242150
    • Texas
      • Lubbock, Texas, United States, 79410
        • Recruiting
        • Joe Arrington Cancer Research /ID# 242226
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute- First Hill /ID# 242269
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Multicare Institute for Research and Innovation /ID# 242127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of:

    -- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:

    • DLBCL, not otherwise specified (NOS).
    • High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.
    • Follicular lymphoma (FL) Grade 3B. OR
  • FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR
  • Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, FISH, or polymerase chain reaction (PCR).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arms 6 and 7 where ECOG performance status must be 0-1.

  • Must have 1 or more measurable disease sites:

    • A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
    • At least 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or magnetic resonance imaging (MRI).

Exclusion Criteria:

  • Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
  • Toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Dose Escalation
Participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will receive escalating doses of subcutaneous (SC) epcoritamab in combination with oral lenalidomide in 28 day cycles.
Drug: Lenalidomide
Oral; Capsule
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Experimental: Arm 2: Dose Escalation
Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
Drug: Lenalidomide
Oral; Capsule
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Drug: Ibrutinib
Oral; Capsule
Other Names:
  • Imbruvica
Experimental: Arm 3: Dose Escalation
Participants with newly diagnosed treatment-naïve DLBCL will receive escalating doses of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Drug: Rituximab
Intravenous (IV); Injection
Drug: Cyclophosphamide
IV; Injection
Drug: Doxorubicin Hydrochloride [HCl]
IV; Injection
Drug: Prednisone
Oral; Tablet
Drug: Polatuzumab Vedotin
IV; Injection
Experimental: Arm 1: Dose Expansion
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral lenalidomide in 28 day cycles.
Drug: Lenalidomide
Oral; Capsule
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Experimental: Arm 2: Dose Expansion
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
Drug: Lenalidomide
Oral; Capsule
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Drug: Ibrutinib
Oral; Capsule
Other Names:
  • Imbruvica
Experimental: Arm 3: Dose Expansion
Participants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Drug: Rituximab
Intravenous (IV); Injection
Drug: Cyclophosphamide
IV; Injection
Drug: Doxorubicin Hydrochloride [HCl]
IV; Injection
Drug: Prednisone
Oral; Tablet
Drug: Polatuzumab Vedotin
IV; Injection
Experimental: Arm 4: Dose Escalation
Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Drug: CC-99282
Oral; Capsule
Experimental: Arm 5: Dose Escalation
Participants with R/R follicular lymphoma (FL) will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Drug: CC-99282
Oral; Capsule
Experimental: Arm 6A: Dose Escalation
Participants with R/R mantle cell lymphoma (MCL) will receive escalating doses of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Drug: Ibrutinib
Oral; Capsule
Other Names:
  • Imbruvica
Experimental: Arm 6B: Dose Escalation
Participants with R/R MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Drug: Ibrutinib
Oral; Capsule
Other Names:
  • Imbruvica
Drug: Venetoclax
Oral; Tablet
Other Names:
  • ABT-199
  • GDC-0199
  • Venclexta;
Experimental: Arm 7: Dose Escalation
Participants with newly diagnosed treatment-naïve MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Experimental: Arm 4: Dose Expansion
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Experimental: Arm 5: Dose Expansion
Participants with R/R FL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Experimental: Arm 6: Dose Expansion
Participants with R/R MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
Drug: Ibrutinib
Oral; Capsule
Other Names:
  • Imbruvica
Experimental: Arm 7: Dose Expansion
Participants with newly diagnosed treatment-naïve MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
Drug: Ibrutinib
Oral; Capsule
Other Names:
  • Imbruvica
Drug: Venetoclax
Oral; Tablet
Other Names:
  • ABT-199
  • GDC-0199
  • Venclexta;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Dose-Limiting Toxicities (DLT)
Time Frame: Up to Approximately 5 Years
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Up to Approximately 5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DOR) per Investigator
Time Frame: Up to Approximately 5 Years
DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by the investigator, or death from any cause.
Up to Approximately 5 Years
Number of Participants with Progression-free survival (PFS)
Time Frame: Up to Approximately 5 Years
PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
Up to Approximately 5 Years
Percentage of Participants with Complete Response (CR)
Time Frame: Up to Approximately 5 Years
CR is defined as the percentage of participantswho achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.
Up to Approximately 5 Years
Time-to-response (TTR)
Time Frame: Up to Approximately 5 Years
TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator.
Up to Approximately 5 Years
Rate of Minimal Residual Disease (MRD) Negativity
Time Frame: Up to Approximately 5 Years
MRD is defined as the percentage of participants with assessment of the minimal residual disease.
Up to Approximately 5 Years
Overall Survival (OS)
Time Frame: Up to Approximately 5 Years
(OS) is defined as the time in months from first dose of epcoritamab to death from any cause.
Up to Approximately 5 Years
Best Overall Response (BOR) per Investigator
Time Frame: Up to Approximately 5 Years
BOR is defined as the percentage of participants who achieved best overall response of CR or PR by Lugano 2014 criteria as assessed by the investigator.
Up to Approximately 5 Years
Time to Next Antilymphoma Therapy (TTNT)
Time Frame: Up to Approximately 5 Years
Time to next antilymphoma therapy.
Up to Approximately 5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

Genmab

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2022

Primary Completion (Estimated)

November 26, 2032

Study Completion (Estimated)

November 26, 2032

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M22-132
  • 2021-005725-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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