EUCTR2014-001949-25-DE
Active, not recruiting
Phase 1
A Phase I/II study of the tumor-targeting human L19IL2 monoclonal antibody-cytokine fusion protein in combination with Rituximab in relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL)
Philogen S.p.A.0 sites20 target enrollmentJuly 28, 2014
ConditionsRelapsed or refractory CD20+ diffuse large B-cell lymphoma (DLBCL) in patients who are ineligible for autologous stem cell transplantation or who relapse/progress after transplantation.MedDRA version: 17.0Level: LLTClassification code 10012907Term: Diffuse mixed small and large cell lymphoma (Diffuse large B-cell lymphoma) recurrentSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10012908Term: Diffuse mixed small and large cell lymphoma (Diffuse large B-cell lymphoma) refractorySystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed or refractory CD20+ diffuse large B-cell lymphoma (DLBCL) in patients who are ineligible for autologous stem cell transplantation or who relapse/progress after transplantation.
- Sponsor
- Philogen S.p.A.
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Histologically confirmed CD 20\-positive DLBCL
- •2\.Patients must have experienced relapse after or did not achieve CR with standard R\-CHOP\-like treatment and must be ineligible for autologous stem cell transplantation or must have relapsed/progressed after autologous or allogeneic stem cell transplantation
- •3\.Presence of measurable lesions according to Revised response criteria for malignant lymphoma
- •4\.Males or females, age \= 18 years
- •5\.ECOG performance status \= 2
- •6\.Life expectancy of at least 12 weeks
- •7\.Absolute neutrophil count \> 1\.5 x 10^9/L
- •8\.Hemoglobin \> 8\.0 g/dL
- •9\.Platelets \> 50 x 10^9/L
- •10\.Total bilirubin \= 30 µmol/L (or \= 2\.0 mg/dl)
Exclusion Criteria
- •1\.Primary central nervous system lymphoma
- •2\.Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis \& Ti) or any cancer curatively treated \< 5 years prior to study entry
- •3\.History of HIV infection or infectious hepatitis B or C
- •4\.Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study
- •5\.History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris
- •6\.Inadequately controlled cardiac arrhythmias including atrial fibrillation
- •7\.Heart insufficiency (\> Grade II, New York Heart Association (NYHA) criteria)
- •8\.Uncontrolled hypertension
- •9\.Ischemic peripheral vascular disease (Grade IIb\-IV)
- •10\.Severe diabetic retinopathy
Outcomes
Primary Outcomes
Not specified
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