DRKS00009416CompletedPhase 2
Rescue treatment with the monoclonal anti CD20-antibody Obinutuzumab (GA101) in combination with PixantrOne for the treatment of patients with relapsed Aggressive B-cell Lymphoma - ETN-1: GOA
niversitätsmedizin der Johannes Gutenberg-Universität Mainz0 sites70 target enrollmentStarted: October 13, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 70
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •Patients aged = 18 years
- •-Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed indolent lymphoma according to the World Health Organization classification (central pathology review)
- •-Relapsed disease
- •-Eastern Cooperative Oncology Group [ECOG] performance Status =2, unless tumor associated
- •-Adequate cardiac reserve: Serum Troponin level must be consistent with no significant acute or chronic myocardial damage and there should be no evidence of symptomatic disease
- •-No curative option available
- •-At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
- •-Adequate bone marrow reserve: Platelets of at least 100.000/µl (in case of extensive BM-infiltration 75.000/µl may be acceptable after discussion with the coordinating investigator), absolute neutrophil count of at least 1000/µl. Adequate hepatic and renal function: Alanine aminotransferase <2.5 x upper limit of normal (ULN); Aspartate aminotransferase <2.5 x ULN, total bilirubin <1.5 x ULN
- •-No active Hepatitis B or C or HIV-infection
- •-Measured or calculated creatinine clearance >30 mL/min
- •-Fresh tumor biopsy or archived tissue available
- •-Ability of patients to understand nature, importance and individual consequences of clinical trial.
- •-Signed informed consent
- •-Women post-menopausal for more than two years can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (serum or urine) is available before trial and they are willing to practice a highly effective and medically accepted contraception method during trial and for a period of 18 months post-treatment. Reliable contraception comprises systematic contraceptives (oral, implant, injection) or diaphragm / condoms / intrauterine devices (IUP) with spermicide.
- •-Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period of 6 months post-treatment
Exclusion Criteria
- •-Lymphoma other than DLBCL, FL IIIB, transformed indolent NHL
- •-CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
- •-Pregnant or breast-feeding women
- •-Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinaemia)
- •-Myocardial infarction within the last 6 months
- •-Active uncontrolled infections including HIV-positivity, active Hepatitis B or C
- •-Vaccination with live vaccine within last 4 weeks
- •-Mental status precluding patient’s compliance
- •-Known CD20 negativity
- •-Diagnosed or treated for a malignancy other than NHL except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, DCIS of the breast, or other solid tumors curatively treated with no evidence of disease for >3 years, or prostate cancer with a life expectancy of more than 2 years
- •-Treatment with any approved anticancer agent within last 2 weeks. Any agents must have been stopped at least 2 weeks prior to day 1 of GOAL treatment and all treatment related adverse events must have returned to Grade 1.
- •-Prior exposition to Obinutuzumab or Pixantrone
- •-History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
- •-Active participation in other interventional clinical trials during the present clinical trial or within the last 2 weeks prior to treatment initiation. Concurrent participation in non-treatment studies is not excluded
- •-Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
Investigators
Similar Trials
Completed
Not Applicable
Anti-CD20 monoclonal antibody therapy for type II mixed cryoglobulinemia syndromeMixed cryoglobulinemia HCV- related or unrelatedHaematological DisordersCryoglobulinaemiaISRCTN55287110niversity of Udine (Italy)124
Completed
Not Applicable
Anti-CD20 treatment of relapsed or refractory immune thrombocytopaenic purpura (ITP) after first line corticosteroid treatmentImmune thrombocytopaenic purpura (ITP)Haematological DisordersPurpura and other haemorrhagic conditionsISRCTN16619820Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands) - Data Centre150
Active, not recruiting
Not Applicable
Efficacy of monoclonal anti CD 20 antibodies in steroid and cyclosporin dependent nephrotic syndrome in children - NDephrotic SyndromeMedDRA version: 9.1Level: LLTClassification code 10029164Term: Nephrotic syndromeEUCTR2008-004486-26-ITISTITUTO GIANNINA GASLINI
Completed
Not Applicable
Anti-CD20 therapy for the treatment of chronic Graft Versus Host DiseaseChronic Graft Versus Host Disease (cGVHD)Injury, Occupational Diseases, PoisoningFailure and rejection of transplanted organsISRCTN43525354niversity Medical Center Utrecht (UMCU) (The Netherlands)30
Active, not recruiting
Phase 1
Phase I/II Study combining humanised anti-CD20 (veltuzumab), anti-CD22 (epratuzumab) and both monoclonal antibodies with chemotherapy in adults with recurrent B precursor acute lymphoblastic leukaemia (ALL)- MARALL - Monoclonal Antibodies In Recurrent B cell ALL (MARALL)This is a phase I/ II trial to determine the efficacy of intravenous veltuzumab and epratuzmab either individually or together in combination with chemotherapy in patients with recurrent acute lymphoblastic lymphoma.MedDRA version: 9.1 Level: LLT Classification code 10003890 Term: B precursor type acute leukaemiaMedDRA version: 9.1 Level: LLT Classification code 10003917 Term: B-cell type acute leukaemiaEUCTR2008-002286-32-GBQueen Mary Medical University of London27