Study of Phase I/II of the combination of L19IL2 with Rituximab in Diffuse Large B-cell Lymphoma
- 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.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]
- Registration Number
- EUCTR2014-001949-25-DE
- Lead Sponsor
- Philogen S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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)
11.No abnormal electrocardiogram findings requiring treatment
12.ALT and AST = 3.0 x the upper limit of normal (ULN) (5.0 x ULN for patients with hepatic involvement with tumor)
13.Serum creatinine < 2 x ULN
14.All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade = 1 unless otherwise specified above
15.Negative serum pregnancy test (for women of child-bearing potential only) at screening
16.If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug
17.Able to provide written Informed Consent
18.Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
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
11.Active autoimmune disease
12.History of organ allograft or stem cell transplantation
13.Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment
14.Known history of allergy to IL2 or other human proteins/peptides/antibodies
15.Positive serum pregnancy test (for women of child-bearing potential only) at screening
16.Breast feeding female
17.Anti-tumor therapy within 4 weeks of the administration of study treatment (except small surgery)
18.Patient requires or is taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion
19.Any conditions that in the opinion of the investigator could hamper compliance with the study protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method