A Phase 3 study of Tafasitamab plus Lenalidomide in patients withRelapsed or Refractory Diffuse Large B-Cell Lymphoma.
- Conditions
- MedDRA version: 21.0Level: LLTClassification code 10012883Term: Diffuse lymphomaSystem Organ Class: 100000004864Diffuse large B-cell lymphoma (DLBCL)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-006049-36-FI
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 81
* Men and women aged = 18 years at the time of consent.
* Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures.
* 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
* Disease history that meets the following criteria:
a. Relapsed/progressive/recurrent disease, defined as the appearance of any new lesions or increase by = 50% of previously involved sites from nadir according to the International Working Group response criteria after the most recent systemic therapy.
OR
Refractory disease, defined as having had less than a PR to the most recently administered systemic therapy.
b. At least one bidimensionally measurable disease site. The lesion must have a greatest transverse diameter of = 1.5 cm and greatest perpendicular diameter of = 1.0 cm at baseline, and must be positive on PET scan.
c. Received at least 1, but no more than 3 previous systemic regimens for the treatment of DLBCL. One line of therapy must have included an anti-CD20-targeted therapy.
d. Disease which is not amenable to intensive salvage therapy including ASCT due to pre-existing comorbidities or participant refusal. Documentation of the reason must be provided in the patient's source data.
For the full list of inclusion criteria, please refer to the study protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 71
* Women who are pregnant or breastfeeding.
* 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.
* History or evidence of CNS lymphoma (primary and secondary).
* Prior treatment with CD19-targeted therapy or IMiDs (eg, thalidomide, lenalidomide)
*Previous allogenic stem cell transplantation
For the full list of exclusion criteria, please refer to the study protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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 Objective: To further evaluate additional efficacy outcomes in study participants using the 2014 Lugano Classification.<br><br>To determine the safety and tolerability of tafasitamab plus lenalidomide in study participants.;Primary end point(s): ORR, defined as the percentage of participants having best response of CR or PR as per IRC assessment.;Timepoint(s) of evaluation of this end point: throughout the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): *DOR, defined as the time from the first documented CR or PR until the date of first documented disease progression or death due to any cause, whichever occurs first, among participants who achieve CR or PR per IRC assessment.<br><br>* PFS, defined as the time from the date of first dose until the first documented disease progression, or death due to any cause, whichever occurs first per IRC assessment.<br><br>* DCR, defined as the percentage of participants who achieve CR, PR, or SD as per IRC assessment.<br><br>* TTNT, defined as the time from first dose until the initiation of new anticancer therapy or death due to any reason.<br><br>* OS, defined as the time from the date of first dose until death due to any cause.<br><br>* ORR, DOR, PFS, and DCR as per investigator assessment of response.<br><br>* Safety and tolerability assessed by monitoring incidence and severity of TEAEs.;Timepoint(s) of evaluation of this end point: throughout the study