EUCTR2006-006891-39-BE进行中（未招募）不适用
A phase I/II open label study of IPH1101 (with low dose of interleukin-2 [IL-2]) in combination with rituximab re-treatment in patients with Follicular Lymphoma.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent prior to any protocol-specific procedures,
- •2. Histologicy documented diagnosis of follicular non-Hodgkin’s lymphoma,
- •3. Follicular lymphoma of grade 1 or 2 (WHO [World Health Organisation] classification),
- •Note: 3a patients will also be allowed, but only if the absence of transformation to high grade lymphoma was documented by a lymph-node biopsy done at Screening.
- •4. Progression after one, two, three or four previous line(s) of therapy,
- •5. At least one but not more than two of the prior line(s) of therapy must have been a rituximab-containing treatment,
- •6. At least 4 weeks from Screening since previous systemic anti-cancer therapy, including steroids,
- •7. Interval at Screening from last administration of previous systemic therapy for fludarabin-, rituximab- or ibritumomab tiuxetan-containing therapies, or autologous therapy with auto transplantation:
- •- 6 months in case of fludarabine-containing treatment or autologous therapy with auto transplantation,
- •- 6 months in case of rituximab-containing chemotherapy or ibritumomab tiuxetan,
- •- maintenance therapy accepted, with the same 6-month clearance period.
- •8. Measurable disease evaluable by Cheson et al. 1999 criteria 2
- •9. At least 2 weeks from Screening since previous surgery,
- •10. Aged > 18 years and = 75 years,
- •11. Eastern Cooperative Oncology Group (ECOG) performance status = 1 (i.e. 0, or 1),
- •12. Adequate bone marrow, hepatic and renal function as follows:
- •- White blood cells (WBC) = 3.5 x 109/L, neutrophils = 1 x109/L, lymphocytes > 1 x 109/L,
- •- Platelets = 60 x 109/L,
- •- Haemoglobin = 8 g/dL or 5.6 mmol/L,
- •- Total bilirubin = 2 x upper limit normal (ULN) and transaminases (alanine amino transferase / serum glutamic pyruvic transaminase [ALT / SGPT]; aspartate amino transferase /serum glutamic oxalo-acetic transaminase [AST / SGOT]) = 3 x ULN,
- •OR if liver metastases, total bilirubin and transaminases = 5 x ULN,
- •- Serum creatinine = 2 x ULN,
- •- Alkaline Phosphatase (ALP) = 3 x ULN,
- •13. Electrocardiogram (ECG) QTc interval duration < 430 ms for men, < 450 ms for women,
- •14. Patient may have received prior radiotherapy but not for the treatment of lesions that will be used to assess efficacy. A minimum of 4 weeks must have elapsed prior to Screening.
- •15. Patients (male and female) who accept and are able to use recognised highly effective contraception methods (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) throughout the study and up to 12 months after last dose of study drug, if applicable,
- •16. Life expectancy >12 weeks.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any mass > 7 cm,
- •2. Pleural or peritoneal effusion,
- •3. Non easily measurable disease such as: isolated
- •- mesenteric panniculitis,
- •- bone marrow infiltration,
- •- bone lytic lesion,
- •- epiduritis,
- •- cutaneous follicular lymphoma.
- •4. LDH > ULN,
- •Note: patients with LDH > ULN from 1.0 to 2.0 ULN will also be allowed, but only if the absence of transformation to high grade lymphoma was documented by a lymph-node biopsy performed at Screening.
- •5. Transformation to high grade lymphoma (secondary to low grade lymphoma),
- •Note: If the investigator suspects transformation by clinical examination, a repeat lymph-node biopsy will be required prior to enrolment to document the absence of transformation.
- •6. Pregnant or lactating women,
- •7. Human immuno-deficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) positive serology at Screening,
- •8. Concurrent treatment with any other anti-cancer therapy or with other experimental drugs, participation in another clinical study with any investigative drug within 30 days prior to study Screening,
- •9. Concurrent treatment with:
- •- biphosphonates,
- •- immunosuppressive agents,
- •- anticancer hormonal therapy,
- •- systemic and chronic inhaled steroids,
- •- beta-blockers and calcium channel blockers.
- •10. Prior history of high-dose chemotherapy followed by allogenic bone marrow or peripheral stem cell support/transplant, or presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to study Screening),
- •11. Prior history of mini-allogenic bone marrow transplantations,
- •12. Any known hypersensitivity to one of the study treatments,
- •13. Current active infection; serious concurrent, uncontrolled medical disorder such as diabetes, autoimmune disease, etc (at investigator’s discretion),
- •14. Cardiovascular disease:
- •- Stage III or IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure.
- •Note: patients with NYHA stage I or II CHF may be included provided they do not have arrhythmia requiring treatment or fulfil any other exclusion criteria.
- •- Myocardial infarction within the previous 6 months, or
- •- Symptomatic cardiac arrhythmia requiring treatment,
- •15. Left ventricular ejection fraction < 45% (as assessed by Multiple Gated Acquisition Scan [MUGA scan] or cardiac ultrasonography),
- •16. History of another malignancy within the past 5 years, except basal cell carcinoma of the skin or in situ cervix carcinoma,
- •17. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before requesting for enrolment in the study.
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