A Phase 3 study of Tafasitamab plus Lenalidomide in patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Incyte Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

25 Oct 2022 → ongoing

Decision date (initial)

2024-01-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Incyte Corporation

External identifiers

EU CT number

2023-505579-53-00

EudraCT number

2021-006049-36

ClinicalTrials.gov

NCT05429268

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Others, Safety, Efficacy

To determine the efficacy of tafasitamab plus lenalidomide in study participants with R/R DLBCL who are not eligible for HDC/ASCT, using the 2014 Lugano Classification.

Secondary objectives 1

1. To further evaluate additional efficacy outcomes in study participants using the 2014 Lugano Classification. To determine the safety and tolerability of tafasitamab plus lenalidomide in study participants.

Conditions and MedDRA coding

Diffuse large B-cell lymphoma (DLBCL)

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Aged ≥ 18 years at the time of consent. 2. Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures. 3. Histologically-confirmed diagnosis of any of the following: a. Diffuse large B-cell lymphoma not otherwise specified b. T cell/histiocyte-rich large B-cell lymphoma c. Epstein-Barr virus positive DLBCL of the elderly d. Grade 3b follicular lymphoma e. Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse f. Evidence of histological transformation from an earlier diagnosis of low grade lymphoma (ie, an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL, with a subsequent DLBCL relapse 4. Willingness to undergo tumor biopsy requirements for the study, including an incisional, excisional, or core needle lymph node or tissue biopsy (or have archival lymph node or tissue block from the most recent biopsy, not to exceed 3 years prior to C1D1). 5. Willingness to undergo bone marrow biopsy/aspirate collections as appropriate. Please refer to protocol for a complete list of inclusion criteria.

Exclusion criteria 1

1. 1. Any other histological type of lymphoma according to the WHO 2016 classification of lymphoid neoplasms, including: a. primary mediastinal (thymic) large B-cell lymphoma b. Burkitt lymphoma c. Primary refractory DLBCL, defined as disease progressing in the course of the first line treatment, and/or showing a response of less than a PR to first-line treatment, or disease recurrence/progression within < 6 months from the completion of first-line therapy. d. History of double- or triple-hit DLBCL, characterized by simultaneous detection of MYC with BCL2 and/or BCL6 translocation(s) as per fluorescence in situ hybridization. MYC, BCL2, BCL6 testing prior to study enrollment is not required. 2. History or evidence of CNS lymphoma (primary and secondary). 3. Prior treatment with CD19-targeted therapy or IMiDs (eg, thalidomide, lenalidomide) 4. Participants who, within 30 days prior to Cycle 1 Day 1, have: a. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy b. Undergone major surgery or suffered from significant traumatic injury c. Received live vaccines or have an anticipated need for such vaccination while receiving study treatment d. Required parenteral antimicrobial therapy for active, intercurrent infections 5. Have undergone ASCT within the period ≤ 3 months prior to signing consent. If an ASCT was performed > 3 months prior to signing consent, full hematological recovery must be demonstrated before enrollment into the study. Please refer to protocol for a complete list of exclusion criteria.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ORR (overall response rate), defined as the percentage of participants having best response of CR or PR as per IRC assessment.

Secondary endpoints 1

1. • DOR (Duration of Response), defined as time from 1st documented CR (complete response) or PR (partial response) until the date of 1st documented disease progression or death due to any cause, whichever occurs first, among participants who achieve CR or PR per IRC (independent review committee) assessment. Refer protocol for complete list.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Incyte Corp.

Sponsor organisation

Incyte Corp.

Address

1801 Augustine Cut Off

City

Wilmington

Postcode

19803-4404

Country

United States

Scientific contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Public contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Third parties 10

Locations

10 EU/EEA countries · 37 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 189 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications