An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory MantleCell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma

Phase 1

• Conditions: MedDRA version: 18.0Level: HLTClassification code 10016903Term: Follicle centre lymphomas, follicular grade I, II, IIISystem Organ Class: 100000004851; MedDRA version: 18.0Level: HLTClassification code 10026798Term: Mantle cell lymphomasSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]; Relapsed or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma; MedDRA version: 18.0Level: HLTClassification code 10012819Term: Diffuse large B-cell lymphomasSystem Organ Class: 100000004851

• Registration Number: EUCTR2014-005299-26-BE
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-05
• Last Update Posted: 10 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Has diagnosis and prior treatment for each non-hodgkin's lymphoma (NHL) subtype as
defined below: Mantle cell lymphoma (MCL): pathologically verified diagnosis of MCL based on local
pathology report, relapsed or refractory disease after at least 2 but not more than 5 prior lines of therapy,
including at least one cycle of ibrutinib therapy and documented progressive disease (PD) during or after
ibrutinib treatment or participants who could not tolerate ibrutinib (ie, discontinued ibrutinib due to adverse
events [AEs]), b) Diffuse large B cell lymphoma (DLBCL): pathologically confirmed diagnosis of nontransformed
DLBCL, and c) relapsed or refractory disease; participants are not eligible or considered a
candidate for high-dose chemotherapy and autologous stem cell transplantation due to other organ
dysfunction or comorbidities (especially pulmonary or cardiac), c) Follicular lymphoma (FL): pathologically
confirmed diagnosis of FL of Grade 1, 2, or 3a according to World Health Organization (WHO) criteria
without pathological evidence of transformation, and relapsed disease after at least two prior systemic
therapies including one anti-CD20 containing combination regimen - At least 1 measurable site of disease -
Expression of CD38 by immunohistochemistry on fresh or archived tumor sample by central assessment:
a) Stage 1: participants whose tumors are more than or equal to (>=) 50 percent (%) positive for CD38, b)
Stage 2: participants whose tumors are >=1% positive for CD38 - Participant must have an ECOG
performance status score of 0 or 1 - Women of childbearing potential must commit to either abstain
continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control
simultaneously. A woman of childbearing potential must have a negative serum or urine pregnancy test
within 14 days prior to Cycle 1 Day 1. A man who is sexually active with a woman of childbearing potential
must agree to always use condom during sexual intercourse, and all men must also not donate sperm
during the study and for 4 months after receiving the last dose of study drug
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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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 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
•Participant has a history of malignancy (other than NHL) within 5 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 3 years) - Participant has known
chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less
than (<) 50% predicted normal. Note that FEV1 testing is required for patients suspected of having COPD
and participants must be excluded if FEV1 <50% b) Participant has known moderate or severe persistent
asthma within 2 years (see Attachment 4: NHLBI table of asthma severity), or currently has uncontrolled
asthma of any classification. (Note that participants who currently have controlled intermittent asthma or
controlled mild persistent asthma are allowed in the study)
therapies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified