EUCTR2015-005390-21-ES
Active, not recruiting
Phase 1
Multicentric phase II trial to evaluate the efficacy and safety of Ibrutinib in combination with rituximab, gemcitabine, oxaliplatin and dexamethasone followed by Ibrutinib maitenance in patients with refractory/relapsed non-GCB diffuse large B-cell lymphoma non candidates to ASCT
GELTAMO0 sites64 target enrollmentJanuary 13, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- diffuse large B-cell lymphoma
- Sponsor
- GELTAMO
- Enrollment
- 64
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects with confirmed histologically diagnosis of diffuse large B\-cell lymphoma.
- •2\. Subjects must be 18 years of age or older.
- •3\. Non\-germinal center B\-cell\-like (GCB) subtype according to Hans algorithm (local laboratories).
- •A centralized evaluation by GEP will be carried out to confirm activated B\-cell\-like (ABC) subtype (commercial biotech lab to perform on paraphin samples), but a negative result will not exclude patient from the trial if a response is achieved after 4 cycles.
- •4\. Relapsed or refractory disease after:
- •at least 1 prior line of therapy that includes rituximab in combination with chemotherapy, or,
- •after previous ASCT, or,
- •after reduced intensity conditioning allogeneic transplant, unless patient is receiving immunosuppressive drugs or active graft versus host disease is present at study entry.(Refractory disease is defined as failing to achieve CR after the most recent treatment.)
- •5\. Eastern Cooperative Oncology Group (ECOG) performance status ? 2\.
- •6\. Baseline FDG\-PET scan demonstrating positive lesions (Deauville 4 or 5\) compatible with CT defined anatomical tumor sites.
Exclusion Criteria
- •1\. Prior malignancy other than DLBCL, with the exception of adequately treated basal cell or squamous cell skin tumor, in situ cervical cancer, or other tumor from which the patient has been disease free for at least 2 years or which will not limit survival to \< 2 years (Note: these cases must
- •be discussed with the Principal Investigator).
- •2\. Candidates to autologous stem cell transplant.
- •3\. Any life\-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib, or put the study outcomes at undue risk.
- •4\. Significant cardiovascular disease such as uncontrolled or symptomatic
- •arrhythmias, congestive heart failure, or myocardial infarction within 6
- •months of screening, or any Class 3 or 4 cardiac disease as defined by
- •the New York Heart Association Functional Classification.
- •5\. Malabsorption syndrome, disease significantly affecting gastrointestinal
- •function, or resection of the stomach or small bowel or ulcerative colitis,
Outcomes
Primary Outcomes
Not specified
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