An Open Label, Phase 2 Study to Evaluate Efficacy and Safety of Daratumumab in Relapsed or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma

Phase 2

Completed

• Conditions: Non Hodgkin lymphoma; lymphoma; 10025320

• Registration Number: NL-OMON43938
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Key eligibility criteria include the following: subjects who are *18 years of age, have histologically
confirmed diagnosis of MCL, DLBCL, or FL and measurable disease, centrally determined expression
levels of CD38, and an ECOG performance status score of 0 or 1. Key criteria for each NHL subtype:
MCL:
* pathologically verified diagnosis of MCL based on local pathology report, AND
* relapsed or refractory disease after at least 2 prior lines of therapy, including at
least one cycle of BTK inhibitor therapy and documented PD during or after BTK inhibitor treatment or subjects who could not tolerate BTK inhibitor (ie, discontinued BTK inhibitor due to AEs)
DLBCL:
* pathologically confirmed diagnosis of non-transformed DLBCL, AND
* relapsed or refractory disease; for those subjects who have not received HDT/ASCT are not eligible for HDT/ASCT due to comorbidities
FL:
* pathologically confirmed diagnosis of FL of Grade 1, 2, or 3a according to World Health
Organization criteria without pathological evidence of transformation, AND
* relapsed disease after at least two prior systemic therapies including one anti-CD20 containing
combination regimen

Exclusion Criteria

Known central nervous system lymphoma - Prior anti-tumor therapy including (all times measured prior to start of study drug): nitrosoureas within 6 weeks chemotherapy within 3 weeks therapeutic antibodies within 4 study drug): nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 2 weeks, investigational agents within 3 weeks, unless antibody this should be within 4 weeks - Daratumumab or other anti-CD38 therapies - Participant has a history of malignancy (other than NHL) within 3 years before the screening period (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, non-muscle invasive bladder cancer (papillary neoplasms of low malignant potential and primary noninvasive tumors), or malignancy that in the opinion of the investigator, with concurrence with the sponsor's
medical monitor, is considered cured with minimal risk of recurrence within 2 years).

Study & Design

• Study Type: Interventional
• Study Design: Not specified