Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin´s Lymphoma (NHL)
This trial is active, not recruiting.
|Treatment||mor00208 (formerly xmab 5574)|
|Start date||May 2013|
|End date||November 2016|
|Trial size||120 participants|
|Trial identifier||NCT01685008, 2012-002659-41, MOR208C201|
This is an open-label, multicentre study to characterize the safety and preliminary efficacy of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory non-Hodgkin´s lymphoma (NHL) who have received at least 1 prior therapy containing rituximab (at least once).
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
intravenous Infusion of MOR00208, Fc-Optimized Anti-CD19 Antibody
Overall response rate (ORR)
time frame: 4 years
1. Patients response duration evaluation by hematology, bone marrow aspirated or biopsy, CT
time frame: bi monthly, up to 48 months
2. Safety will be evaluated by assessing adverse events, clinical lab data and vital signs, ECG, physical exam
time frame: weekly, up to 4 years
3. Pharmacokinetics of MOR00208 (Pharmacokinetic assessment comprises: Cmax, tmax, t1/2, CL
time frame: weekly, up to 12 weeks; 0, 1, 4, 24 hours post dose
4. Number of patients who develop anti-MOR00208 antibodies as a measure of immunogenicity
time frame: monthly up to 4 years
Male or female participants at least 18 years old.
- male or female patients ≥ 18 years of age.
- histologically-confirmed diagnosis according to REAL/WHO classification, of the following B-cell lymphomas :
- Other indolent NHL (eg, MZL/MALT)
- Patients' NHL must have progressed after at least 1 prior rituximab containing regimen.
- one site of measurable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan defined as at least one lesion that measures at least 1.5 × 1.5 cm, Exception: For patients with MCL only, patients with nonmeasurable disease but evaluable sites (bone marrow, spleen, peripheral blood, gastrointestinal tract) can be enrolled.
- Patients who have previously received an autologous stem cell transplantation must be at least 4 weeks post-transplant before study drug administration and must have exhibited a full haematological recovery
- discontinued previous monoclonal antibody therapy (except rituximab) or radioimmunotherapy administration for at least 60 days before study drug administration.
- off rituximab for at least 14 days before the screening visit and be confirmed to have either no response or have disease progression after rituximab treatment.
- Patients with DLBCL had a positive [18F]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan at baseline (Cheson response criteria)
- Life expectancy of > 3 months.
- ECOG performance status of < 3.
- laboratory criteria at screening:
- Absolute neutrophil count (ANC) ≥ 1.0 (1000/mm3)
- Platelet count ≥ 75 × 109/L without previous transfusion within 10 days of first study drug administration
- Haemoglobin ≥ 8.0 g/dL (may have been transfused)
- Serum creatinine < 2.0 x upper limit of normal (ULN)
- Total bilirubin ≤ 2.0 × ULN
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
- If a female of childbearing potential, a negative pregnancy test must be confirmed before enrolment and use of double-barrier contraception, oral contraceptive plus barrier contraceptive, or confirmation of having undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation.
- If a male, an effective barrier method of contraception must be used during the study and for 3 months after the last dose if the patient is sexually active with a female of childbearing potential.
- able to comply with all study-related procedures, medication use, and evaluations.
- able understand and give written informed consent and comply with the study protocol.
- Previous treatment with cytotoxic chemotherapy, immunotherapy, radiotherapy or other lymphoma specific therapy within 14 days before the screening visit or patient has not recovered from side effects of previous lymphoma-specific therapy.
- Treatment with a systemic investigational agent within 28 days before the screening visit.
- Previous treatment with an anti-CD19 antibody or fragments
- Previous allogenic stem cell transplantation.
- Known or suspected hypersensitivity to the excipients contained in the study drug formulation.
- Clinically significant cardiovascular disease or cardiac insufficiency,cardiomyopathy, preexisting clinically significant arrhythmia, acute myocardial infarction within 3 months of enrolment, angina pectoris within 3 months of enrolment.
- Clinical or laboratory evidence of active hepatitis B or hepatitis C 8. History of HIV infection.
- Any active systemic infection (viral, fungal, or bacterial) requiring active parenteral antibiotic therapy within 4 weeks of study drug administration.
- Current treatment with immunosuppressive agents other than prescribed corticosteroids (not more than 10-mg prednisone equivalent).
- Major surgery or radiation therapy within 4 weeks before first study drug administration.
- Systemic diseases (cardiovascular, renal, hepatic, etc) that would prevent study treatment in the investigator's opinion.
- History or clinical evidence of central nervous system (CNS), meningeal, or epidural disease, including brain metastasis.
- Active treatment/chemotherapy for another primary malignancy within the past 5 years
- Pregnancy or breastfeeding in women and women of childbearing potential not using an acceptable method of birth control.
- History of noncompliance to medical regimens or patients who are considered potentially unreliable not cooperative
|Official title||A Phase IIa, Open-label, Multicenter Study of Single-Agent MOR00208, an Fc-optimized Anti-CD19 Antibody in Patients With Relapsed or Refractory Non-Hodgkin´s Lymphoma (NHL)|
|Principal investigator||Kristi Blum, MD|
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