An Effectiveness and Safety Study of Daratumumab in Relapsed/Resistant Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma


About this study

The purpose of this study is to assess overall response rate, including complete and partial response, of daratumumab in patients with relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Has had diagnosis and prior treatment for atleast one non-hodgkin's lymphoma (NHL) subtype 
    • Mantle cell lymphoma (MCL)
      • Pathologically verified 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 
      • Documented progressive disease during or after ibrutinib treatment or participants who could not tolerate ibrutinib (ie, discontinued ibrutinib due to adverse events 
    • Diffuse large B cell lymphoma (DLBCL)
      • Pathologically confirmed diagnosis of non-transformed DLBCL
      • Relapsed or refractory disease
      • Not considered a candidate for high-dose chemotherapy and autologous stem cell transplantation due to other organ dysfunction or comorbidities (especially pulmonary or cardiac)
    • Follicular lymphoma (FL)
      • Pathologically confirmed Grade 1, 2, or 3a according to World Health Organization (WHO) criteria without pathological evidence of transformation
      • 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
    • Stage 1: participants whose tumors are ≥ 50 % positive for CD38
    • 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 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 
  • Men must also not donate sperm during the study and for 4 months after receiving the last dose of study drug

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,
    • Antibody within 4 weeks 
  • Daratumumab or other anti-CD38 therapies
  • 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 
    • Carcinoma in situ of the cervix
    • Non-muscle invasive bladder cancer (papillary neoplasms of low malignant potential and primary non-invasive tumors)
    • 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) < 50% predicted normal
    • FEV1 testing is required for patients suspected of having COPD and participants must be excluded if FEV1 < 50 % 
  • Participant has known moderate or severe persistent asthma within 2 years or currently has uncontrolled asthma of any classification
    • Participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Taimur Sher, M.B.B.S., M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


Rochester, Minn.

Mayo Clinic principal investigator

Taimur Sher, M.D.

Closed for enrollment

Contact information:

Research Information Center


More information


Publications are currently not available

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