BBR 2778 for Relapsed, Aggressive Non-Hodgkin´s Lymphoma (NHL)
- Conditions
- -C859 Non-Hodgkin lymphoma, unspecifiedNon-Hodgkin lymphoma, unspecifiedC859
- Registration Number
- PER-052-05
- Lead Sponsor
- CELL THERAPEUTIC S.R.L. (CTE),
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Aggressive NHL histologically confirmed.
2. Patients must have received rituximab in previous regimens.
3. At least one objectively measurable lesion.
4. Relapse after 2 or more previous chemotherapy regimens.
5. Patients should be sensitive to the last regimen containing anthracyclines / anthracenedione.
6. Age> 18 years.
7. ECOG functional status <2.
8. Life expectancy> 3 months according to the opinion of the researcher.
9. Hb> 8g / dL, neutrophils> 1.5 x 109 / L and platelets> 50 x109 / L.
10. Serum bilirubin <1.5 x ULN of the institution and creatinine <1.5 ULN and alkaline phosphatase <2.0 x ULN of the institution and AST or ALT <2.0 x ULN of the institution.
11. Patients previously treated with one of the comparative agents should be sensitive to that agent if it will be used in this trial.
12. Patients must have recovered from all acute toxicities of previous therapy.
13. LVEF> 40% determined by MUGA scan.
14. Ability to comply with the schedule of visits and evaluations required by the protocol.
15. Signature of approved informed consent, with understanding of study procedures.
1. Previous treatment with a cumulative dose of doxorubicin or equivalent.
2. Histological diagnosis of Burkitt´s lymphoma, lymphoblastic lymphoma or mantle lymphoma.
3. Active involvement of lymphoma in the CNS based on clinical evaluation.
4. Lymphoma related to HIV.
5. Any chemotherapy, radiotherapy or other anti-cancer treatment within 2 weeks before randomization.
6. Major thoracic and / or abdominal surgery within 2 weeks before randomization.
7. Clinically significant cardiovascular abnormalities.
8. Serious intercurrent infection.
9. History of or clinical symptoms suggestive of HIV infection.
10. History of another disease except: squamous cell skin cancer or basal cells treated curatively, cervical cancer in situ, stage I or II cancer adequately treated of which the patient is in remission or any other cancer of which the patient is free of disease for 5 years.
11. Any condition that, in the opinion of the investigator, places the subject at undue risk, interferes with the results of the study or otherwise, does not make the subject fit.
12. Participation in any other study with experimental drug within 2 weeks before randomization.
13. Pregnant women or those who are breastfeeding.
14. Potentially fertile men and women who do not want to use an adequate contraceptive method during the study and 6 months after the last day of study drug administration.
15. Any circumstance at the time of entry into the study that prevents the completion of the study or the required follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Clinical evaluation.<br>Tumor evaluation and objective response: CT or MRI.<br>Puncture and aspirate of bone marrow.<br>Measure:<br>134/5000<br>Primary efficacy: Complete response rate (CR). Partial response rate (PR) and Trasa of unconfirmed complete response (CRu).<br>Timepoints:Clinical evaluation: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 120, 127, 134, 141, 148, 155, 162.<br>Tumor evaluation and objective response: CT or MRI: Days 50, 106 and at the end of the treatment.<br>Bone marrow puncture and aspiration: At the beginning of treatment and initially positive, it will be repeated at the end of treatment.<br>
- Secondary Outcome Measures
Name Time Method