A Study for Patients With Non-Hodgkin´s Lymphomas
- Conditions
- -C859 Non-Hodgkin lymphoma, unspecifiedNon-Hodgkin lymphoma, unspecifiedC859
- Registration Number
- PER-006-08
- Lead Sponsor
- ELI LILLY AND COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 0
•> 18 years old
• Relapse or progression, during or after receiving at least 1 chemotherapy regimen for T-cell and B-cell lymphoma or 2 previous chemotherapy regimens for aggressive B-cell lymphoma or for whom it is not available a standard treatment that is Intolerant to some standard therapy.
• Samples of the original tumor biopsy or the most recent biopsy should be available and the disease should be confirmed by a local pathologist; Enrollment is based on the evaluation of the local pathologist, however, an independent centralized pathological evaluation can be performed on all patient samples.
• Have measurable injuries
• Having recovered from previous chemotherapy
• Have an operating status of 0, 1 or 2 on the ECOG scale (Annex of protocol S057.8)
• Have a life expectancy of at least 12 weeks
• Have signed the informed consent
• Female and male patients with reproductive potential should use an approved contraceptive method, if appropriate (eg [IUD] intrauterine device, oral contraceptive, barrier device) during and 3 months after discontinuation of the study treatment. Women with the birth potential must have a negative serum pregnancy test within 3 days before receiving the first dose of the study medication
• Have adequate organ functions
• That they have received a drug within the last 30 days, which has not been authorized by a regulatory entity during the time of inclusion in the study.
• Have a history of lymphoma with CNS metastases, except for patients with primary lymphoma of the central nervous system.
• Previous radiation therapy is allowed, but it must have been limited and there must not have been total radiation from the pelvis. Patients must have recovered from the toxic effects of the treatment before being enrolled in the study (except alopecia). The previous radiotherapy treatment must be completed 30 days before being included in the study. Lesions that have been irradiated can not be included as measurable sites of the disease unless the tumor progression in these lesions has been clearly documented since the end of radiotherapy.
• Have a second primary malignancy (except for adequately treated non-melanoma skin cancer, or another cancer that is considered cured by surgical resection or radiation). Patients who had another malignancy in the past are eligible, but have been free of disease for more than 5 years.
• Anti-Lymphoma Therapy within the previous 3 weeks.
• Impossibility of swallowing the pills
• One who can not stop the use of carbamazepine, phenobarbital and phenytoin for at least 14 days before being enrolled in the study
• Pre-treatment with enzastaurin
• Have a serious concomitant systemic disorder, according to the researcher
• Active infection that requires antibiotics
• Having a serious cardiac condition in the opinion of the investigator, such as AML within the previous 6 months, angina, or heart disease as defined by NYHA class III or IV.
• That is known to be HIV positive
• Have an abnormal electrocardiogram including the base electrocardiogram, 12-lead ECG, with QTc interval> 430 msec in men or> 450 msec in women, or QRS duration> 100 msec.
• Being pregnant or breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The Revised Response to the International Workshop NHL Response Criteria (IWRC) will be used to assess responses in patients with Indole B-cell lymphoma, aggressive B-cell lymphoma, and peripheral T-cell lymphomas.<br>Measure:Total tumoral response<br>Timepoints:During treatment<br>
- Secondary Outcome Measures
Name Time Method