Randomized, open-label, phase 3 study of Temsirolimus Intravenous (CCI-779) at two dose levels compared to the treatment of choice of the Investigator in patients with relapsed and refractory mantle cell lymphoma (LCM)

ABORATORIOS WYETH S.A.,0 个研究点目标入组 0 人开始时间: 2006年4月20日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. Mantle cell lymphoma (MCL) confirmed.
•2. Have received from 2 to 7 previous treatments.
•3. Pre-treatment with an alkylating agent and an anthracycline, rituximab, individually or in combination, and a condition that is at least one of the following: • Primary disease refractory to at least 2 regimens. • Refractory to at least 1 regimen after the first relapse. • Refractory or untreated after the second relapse or the greatest relapse. • Refractory to first-line treatment and relapse after second-line treatment.
•4. Measurable disease in an area without previous radiation therapy or clear advance in an area that was previously irradiated with a lymph node or tumor mass> 1.5 cm x 1.5 cm.
•5. Adequate function of the organ and marrow obtained <2 weeks prior to the first dose.
•6. Performance status according to Kamofsky (KPS)> 60%.
•7. Age> 18 years.
•8. Life expectancy> 3 months.
•9. For women of childbearing age, obtain a negative pregnancy test result within a week prior to the first dose.
•10. Desire of male and female patients to use acceptable methods of birth control.
•11. Sign and date the informed consent form.

•1. Patients who have not received at least an intermediate course of treatment after an allogeneic hematopoietic precursor cell transplant.
•2. Pre-treatment in research within 3 weeks of the first dose.
•3. Active metastases of the central nervous system.
•4. Second active malignancy that requires treatment or that would interfere with the evaluation of the response of mantle cell lymphoma.
•5. History of any other primary malignancy with <5 years of documentation of a disease-free state.
•6. Treatment with the following medications within the specified time prior to the first dose: • Chemotherapy, radiotherapy, immunotherapy or major surgery <3 weeks. • Nitrosourea, or mitomycin <6 weeks. • Radioimmunotherapy <8 weeks. • Other non-myelosuppressive modifiers of the biological response <2 weeks.
•7. Current uncontrolled disease.
•8. Immunocompromised patients.
•9. Known hypersensitivity to any of the components of temsirolimus.
•10. Female patients who are breastfeeding.
•11. Any significant medical illness or abnormal laboratory finding would increase the patient´s risk of participating in the study.

发起方

ABORATORIOS WYETH S.A.,