Pixantrone (BBR 2778) versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients with Relapsed Aggressive Non-Hodgkin’s Lymphoma: A Randomized, Controlled, Phase III Comparative Trial - N/A

CELL THERAPEUTICS EUROPE S.r.l.0 个研究点目标入组 320 人开始时间: 2005年4月12日最近更新: 2020年10月13日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 320

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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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. Histologically confirmed aggressive [de novo or transformed] NHL according to
•REAL/WHO classification. The histological specimen used to determine eligibility
•must be the most recently obtained specimen. Clear documentation of transformation
•from indolent lymphoma is needed, if applicable. Lymph node biopsy slides or tissue
•blocks suitable for review must be available.
•transformed indolent lymphoma (areas of follicularity allowed)
•diffuse large B-cell lymphoma
•mediastinal large B-cell lymphoma
•primary effusion lymphoma
•(includes previously called immunoblastic lymphoma)
•peripheral T-cell lymphoma, not otherwise characterized
•(encompasses diffused mixed cell lymphoma)
•anaplastic large cell lymphoma, T/null cell, primary systemic type
•Note: patients with any Ann Arbor stage, International Prognostic Index (IPI) score or bone marrow status are eligible.
•2. Patients must have received rituximab in prior regimens in those countries where it is the standard of care and available at the patient’s institution, and when neoplastic cells express CD20.
•3. At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI that can be followed for response as a target lesion. Patients with the following sites of disease are NOT eligible:
•Patients with only skin lesions or only palpable lymph nodes.
•Patients with spleen or bone marrow as only site of disease.
•4. Relapse after 2 or more prior regimens of chemotherapy, including:
•first line treatment with a standard anthracycline-containing regimen such as
•CHOP or equivalent
•at least one additional combination chemotherapy regimen. High dose
•chemotherapy or chemoradiotherapy with autologous stem cell support counts as
•one prior regimen.
•Allogeneic transplant counts as one prior regimen. In patients with a previous
•allo-transplant, there cannot be any serious or active graft-versus-host disease
•(GvHD) requiring immunosuppressive therapy. (See Section 6.3 for a list of
•exclusionary medications).
•5. Patients must be sensitive to the last anthracycline/anthracenedione containing
•regimen. Sensitive is defined as:
•Previously responded to anthracycline/anthracenedione, and
•Relapsed after a response duration = 6 months.
•6. Age = 18 years.
•7. ECOG performance status of = 2.
•8. Life expectancy = 3 months according to investigator opinion.
•9. Hb = 8g/dL, neutrophils =1.5 x 109/L and platelets = 50 x109/L.
•If there is bone marrow involvement, then neutrophils > 0.5 x 109/L, platelets
•> 10 x 109/L and the ability to provide platelet transfusion, is acceptable.
•10. Serum bilirubin = 1.5 x the institution’s upper limit normal (ULN) and creatinine
•= 1.5 ULN and alkaline phosphatase =2.0 x the institution’s ULN and AST or ALT =
•2.0 x the institution’s ULN. If hepatic involvement by lymphoma is present, AST or
•ALT may be = 5.0 x the institution’s ULN.
•11. Patients previously treated with one of the comparative agents must be sensitive to that agent, if it will be used in this trial. Sensitive is defined as:
•Previously responded to that agent, and
•Relapsed after a response duration = 6 months.
•12. Patients must have recovered from all acute toxicities from prior therapy (except
•alopecia and grade 1 peripheral neuropathy).
•13. LVEF = 40% determined by MUGA scan.
•14. Ability to comply with the visit schedule and assessments required by the protocol.
•15. Signed approved informed consent, with understanding of study procedures.
另有 2 项未显示

排除标准

•Prior treatment with a cumulative dose of doxorubicin or equivalent (see Section
•17.2) exceeding 450 mg/m² according to the following calculation index:
•X/450 + Y/160 < 1 where X is the doxorubicin dose in mg/m² and Y the mitoxantrone dose in mg/m².
•2. Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell
•3. Active CNS lymphoma involvement based on clinical evaluation (if the patient
•requires a diagnostic lumbar puncture due to high risk criteria i.e. sinus involvement,
•high LDH, high IPI, or bone marrow involvement, it will be acceptable to administer
•a one time dose of intrathecal chemotherapy, which can include methotrexate,
•cytarabine and corticosteroids).
•4. HIV-related lymphoma.
•5. Any chemotherapy, radiotherapy, or other anticancer treatment (including
•corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks
•before randomization. For radioimmunoconjugate therapy, there must be 8 weeks
•since last dose or platelet recovery to = 50 x 109/L prior to randomization.
•6. Major thoracic and/or abdominal surgery within the 2 weeks before randomization
•from which the patient has not fully recovered. Patients who have had minor surgery
•may be enrolled after a =1 week recovery period.
•7. Clinically significant cardiovascular abnormalities (equal to NYHA grade III- IV),
•myocardial infarction within the prior 6 months, severe arrhythmia or uncontrolled
•hypertension or uncontrolled angina.
•8. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization or deep
•seated or systemic mycotic infections.
•9. History of or clinical symptoms suggesting HIV infection. Patients with a previous
•history of Hepatitis B (HBV) or Hepatitis C (HCV) infection without clinical symptoms and whose hepatic parameters comply with inclusion criterion number 10 (serum bilirubin, creatinine alkaline phosphatase, ALT and AST levels) and patients with seropositivity presumed to be due to prior vaccination against HBV will not be
•History of another malignancy except: curatively treated basal cell or squamous cell
•skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which
•the patient is currently in remission, or any other cancer from which the patient has
•been disease-free for 5 years.
•11. Any condition which, in the judgment of the Investigator, would place the subject at undue risk, interfere with the results of the study, or make the subject otherwise
•unsuitable.
•12. Participation in any other investigational drug study within 2 weeks before
•randomization. Patient must have recovered from all side effects of other investigational therapy. For radioimmunoconjugate therapy, there must be 8 weeks
•since last dose, or platelet recovery to = 50 x 109/L prior to randomization.
•13. Pregnant women or nursing mothers.
•14. Potentially fertile men and women not willing to use adequate contraception during the study and for 6 months after the last day of study drug administration.
•15. Any circumstance at the time of study entry that would preclude completion of the
•study or the required follow-up.

研究者

发起方

CELL THERAPEUTICS EUROPE S.r.l.

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BBR 2778 for Relapsed, Aggressive Non-Hodgkin´s Lymphoma (NHL)-C859 Non-Hodgkin lymphoma, unspecifiedNon-Hodgkin lymphoma, unspecifiedC859

PER-052-05CELL THERAPEUTIC S.R.L. (CTE),