None listed
Conditions
Interventions
BRANCH A Type of group
This group will be treated with Temsirolimus 175 mg IV every week for 3 weeks followed by 75 mg IV every 1 week up to 2 years or until the disease progresses. It will be administered as an intravenous infusion for about 30 minutes.
Group name:BRANCH C Type of group
This group will be treated with one of the following therapeutic options, according to the investigator s criteria:
1. Fludarabine 25 mg / m2 IV about 30 minutes daily for 5 consecutive days, every 28 days.
2. Chlorambucil 0.1 (0.1-0.2) mg / kg PO daily for 3 to 6 weeks depending on
require 0.4 (0.3-0.8) mg / kg PO every 21 to 28 days.
3. Gemcitabine 1 g / m2 IV around 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days.
4. Cyclophosphamide 300 (200-450)
Sponsors
LABORATORIOS WYETH S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. Imaging: CT scan of the neck, chest, abdomen, pelvis. Measure:Free time of disease progression (PFS). Timepoints:Clinical evaluation: Weeks 0, 1, 5, 60, at the end of the study, and in the event of an adverse event. Imaging: Before starting treatment, weeks 8, 60 and at the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Imaging: CT scan of the neck, chest, abdomen, pelvis. Aspirated and bone marrow biopsy (unilateral or bilateral). Measure:Objective response rate (Complete Response + Complete Response not Confirmed + Partial Response). Time until the answer. Duration of the response. Clinical benefit rate (Complete Response + Complete Response Not Confirmed + Partial Response + Stable Disease). Time to treatment failure (TTF). Time to the next treatment (TTN). Time to tumor progression (TTP). General survival (OS). Death rate for specific cause. Timepoints:Clinical evaluation: Weeks 0, 1, 5, 60, at the end of the study, and in the event of an adverse event. Imaging: Before starting treatment, weeks 8, 60 and at the end of treatment. Bone marrow aspiration and biopsy: Before starting treatment, weeks 8, 60. ; Outcome name:Clinical evaluation Performance status according to Kamofsky (KPS). ECG Chest x-ray Measure:Safety and tolerance of treatment. Timepoints:Clinical evaluation: Weeks 0, 1, 5, 60, at the end of the study, and in the event of an adverse event. Performance status according to Kamofsky (KPS): Weeks 0, 1, 8, 60, at the end of the study. ECG: Weeks 0, 1, 8 and at the end of the study. Chest X-ray: Weeks 0, 1, 5, 8, 60 and at the end of the treatment. ; Outcome name:Serum pregnancy test. Complete blood count with differential. Chemical panel. Cholesterol, triglycerides. Direct bilirubin. Coagulation analysis. Measure:Laboratory exams. Timepoints:Serum pregnancy test: Before starting and at the end of treatment. Complete blood count with differential: Weeks 0, 1, 2, 4, 5, 6, 7, 8, 54, 56, 58, 60, 62, 64 and at the end of treatment. Chemical panel, Cholesterol, triglycerides, direct bilirubin, coagulation analysis: Weeks 0, 1, 5, 8, 60 and at the end of the treatment. ; Outcome name:Tests: Pharmacokinetics (Total blood and bone mar | — |
Countries
Austria, Germany, Italy, Spain, Sweden, United Kindgdom
Outcome results
None listed