EUCTR2004-000480-10-ES进行中（未招募）不适用
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 INC. (EUROPE)-SEDE SECONDARIA0 个研究点目标入组 320 人开始时间: 2005年4月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
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
- •All of the following characteristics are required for study eligibility:
- •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. Lymph node biopsy slides or tissue blocks suitable for review must be available.
- •- follicular lymphoma – grade III
- •- transformed indolent lymphoma
- •- 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 available and when neoplastic cells express CD20.
- •3. At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as 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.
- •5. Patients must be sensitive to anthracycline/anthracenedione. 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 10exp9/L and platelets =100 x10exp9/L. If there is bone marrow involvement then neutrophils >0.5 x 10exp9/L and platelets >50 x 10exp9/L 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 =50% 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.
- •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
- •None of the following characteristics may be present:
- •1. 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. Prior allogenic stem cell transplant.
- •3. Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell lymphoma.
- •4. Active CNS lymphoma.
- •5. HIV-related lymphoma.
- •6. Any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 4 weeks before randomization.
- •7. Major thoracic and/or abdominal surgery within the 4 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.
- •8. Clinically significant cardiovascular abnormalities (equal to NYHA grade II - IV), myocardial infarction within the prior 6 months, severe arrhythmia or uncontrolled hypertension.
- •9. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization or deep seated or systemic mycotic infections.
- •10. History of or clinical symptoms suggesting HIV, HBV or HCV infection. Patients with seropositivity presumed to be due to prior vaccination against Hepatitis B virus will not be excluded.
- •11. History of another malignancy except cured basal cell carcinoma of skin or carcinoma in–situ of uterine cervix.
- •12. 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.
- •13. Other investigational drug study within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy.
- •14. Pregnant women or nursing mothers.
- •15. 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.
- •16. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
研究者
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