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Clinical picture: NHL (Non Hodgkin Lymphoma)
Trial: HOVON-associated CARINA (Protocol 54767414LYM2001)
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms
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
UMCU (M.C. Minnema: email@example.com)
VUMC (M.Chamuleau: firstname.lastname@example.org)
Type of study
Prospective Phase II study
Limited site selection
Echelon level specification
Target number of patients
Date of activation
2. Patient eligibility criteria
Diagnosis and prior treatment for each NHL subtype as defined below:
Relapsed and 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 PD during or after ibrutinib treatment or subjects who could not tolerate ibrutinib (ie, discontinued ibrutinib due to AEs)
pathologically confirmed diagnosis of non-transformed DLBCL, AND
high-dose chemotherapy and autologous stem cell transplantation (HD/ASCT) due to other organ dysfunction or comorbidities (especially pulmonary or cardiac)
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:
Stage 1: subjects whose tumors are ≥50% positive for CD38
Stage 2: subjects whose tumors are ≥1% positive for CD38
Subject must have an ECOG performance status score of 0 or 1
Subject must have pretreatment clinical laboratory values meeting the following criteria during the Screening Phase:
a) hemoglobin ≥7.5 g/dL (≥5 mmol/L) without transfusion support within 7 days before the lab test;
b) absolute neutrophil count (ANC) ≥0.75 x 109/L (ie, ≥750/ μL);
c) platelet count ≥50 x 109/L without transfusion support within 7 days of test;
d) aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN);
e) alanine aminotransferase (ALT) ≤2.5 x ULN;
f) total bilirubin ≤1.5 x ULN, except in subjects with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5 x ULN required);
g) creatinine determined by serum creatinine levels ≤1.5 x ULN or a calculated creatinine clearance of ≥40 mL/min (see Attachment 3 for Cockcroft-Gault formula)
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.
Each subject (or their legally acceptable representative) must sign an informed consent form
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 therapies.
Subject 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 non-invasive 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).
a) Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) < 50% predicted normal. Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 <50%
b) Subject has known moderate or severe persistent asthma within 2 years or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
Subject is known to be seropositive for human immunodeficiency virus (HIV), known to have hepatitis B surface antigen positivity, or known to have a history of hepatitis C
Subject has any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
Subject has clinically significant cardiac disease, including:
myocardial infarction within 1 year before the screening period, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV) uncontrolled cardiac arrhythmia (NCI CTCAE Version 4 Grade ≥2) or clinically significant ECG abnormalities
screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) >470 msec
Subject has known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, or their excipients
Vaccination with live attenuated vaccines within 4 weeks of first study agent administration
Subject is known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder). Subject has any condition for which, in the opinion of the investigator, participation would not be in the
best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 4 months after the last dose of daratumumab. Or, subject is a man who plans to father a child while enrolled in this study or within 4 months after the last dose of daratumumab.
Subject has used an invasive investigational medical device within 4 weeks before the screening period or is currently enrolled in an interventional investigational study.