A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
NCT ID: NCT01205737
Last Updated: 2013-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
186 participants
INTERVENTIONAL
2010-09-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TL011
TL011
375 mg/m2 iv every 3 weeks for 8 cycles
MabThera®
Rituximab
375 mg/m2 iv every 3 weeks for 8 cycles
Interventions
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TL011
375 mg/m2 iv every 3 weeks for 8 cycles
Rituximab
375 mg/m2 iv every 3 weeks for 8 cycles
Eligibility Criteria
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Inclusion Criteria
2.CD20+ lymphoma cells at screening
* 18-80 (inclusive) years of age at screening
* Ann Arbor Stages I-IV at screening
* Any IPI score at screening
* ECOG good performance status (0-2) at screening
* Willing and able to provide written informed consent prior to performing study procedures
* Women of childbearing potential must use effective contraceptive methods starting from screening and until 12 months following the last infusion..
Exclusion Criteria
2. History of indolent lymphoma
3. DLBCL with central nervous system or meningeal involvement
4. Primary gastrointestinal (MALT) lymphoma
5. Bulky disease\>10 cm diagnosed by imaging at screening
6. Bone marrow involvement \> 25% according to bone marrow biopsy at screening
7. Subjects previously treated with chemotherapy, radiotherapy, immunotherapy or experimental therapies for lymphoma or other malignancy
8. Hypersensitivity to active ingredients, excipients (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections) and murine proteins
9. Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
10. A documented history of recurrent or chronic clinically significant infection (viral, bacterial or fungal infection)
11. Subjects with a history of tuberculosis or active tuberculosis at screening.
12. Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity
13. Positive Hepatitis B surface antigen or antibodies to Hepatitis C
14. History of other cancer within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of uterine cervix
15. Any major surgical procedure within 12 weeks prior to screening and between screening and baseline
16. Immunization with live viral vaccines less than 4 weeks prior to first study drug infusion, and/or planned live viral vaccination during study period.
17. Known allergic reactions against foreign proteins
18. Subjects for whom 8 cycles of CHOP might be problematic, and have the following findings/conditions, should not be enrolled:
* Cardiac contra-indication to doxorubicin: Left ventricular ejection fraction (LVEF) \< 50% according to multi-acquisition gated (MUGA) scan or 2D Echocardiogram at screening
* Neurologic contra-indication to vincristine: (e.g., peripheral neuropathy)
* Abnormal hepatic function at screening and/or baseline
* AST/ALT ≥ 3 x upper normal value (ULN) or ≥ 5 x ULN in the presence of DLBCL involvement of the liver
* Bilirubin ≥ 2 x ULN or ≥ 5 x ULN in the presence of DLBCL involvement of the liver
* Abnormal renal function at screening and/or baseline
* Serum creatinine ≥ 2 x ULN
* Abnormal bone marrow function at screening and/or baseline
* Platelets \< 100x109/L
* Neutrophils \< 1.5x109/L
* Hb \< 9g/dL
19. Any other serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the Investigator Brochure of TL011)
20. Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study.
21. Pregnant or lactating women or women that intend to get pregnant during study or within 12 months following the last infusion.
22. Treatment with any investigational drug within 90 days before planned first cycle of chemotherapy.
18 Years
80 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mariano Provencio, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Puerta de Hierro
Locations
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Teva Investigational Site 59005
Pleven, , Bulgaria
Teva Investigational Site 59003
Plovdiv, , Bulgaria
Teva Investigational Site 59001
Sofia, , Bulgaria
Teva Investigational Site 59002
Sofia, , Bulgaria
Teva Investigational Site 59004
Varna, , Bulgaria
Teva Investigational Site 55001
Tallinn, , Estonia
Teva Investigational Site 55002
Tartu, , Estonia
Teva Investigational Site 35066
Paris, , France
Teva Investigational Site 51026
Debrecen, , Hungary
Teva Investigational Site 30001
Florence, , Italy
Teva Investigational Site 30002
Napoli, , Italy
Teva Investigational Site 56002
Daugavpils, , Latvia
Teva Investigational Site 56001
Riga, , Latvia
Teva Investigational Site 56003
Riga, , Latvia
Teva Investigational Site 53010
Warsaw, , Poland
Teva Investigational Site 50011
Arkhangelsk, , Russia
Teva Investigational Site 50001
Chelyabinsk, , Russia
Teva Investigational Site 50006
Kazan', , Russia
Teva Investigational Site 50014
Kursk, , Russia
Teva Investigational Site 50005
Moscow, , Russia
Teva Investigational Site 50009
Moscow, , Russia
Teva Investigational Site 50010
Moscow, , Russia
Teva Investigational Site 50003
Novosibirsk, , Russia
Teva Investigational Site 50017
Pyatigorsk, , Russia
Teva Investigational Site 50012
Saint Petersburg, , Russia
Teva Investigational Site 50015
Tomsk, , Russia
Teva Investigational Site 50004
Yekaterinburg, , Russia
Teva Investigational Site 31005
Elche-Alicante, , Spain
Teva Investigational Site 31006
Las Palmas de Gran Canaria, , Spain
Teva Investigational Site 31002
Madrid, , Spain
Teva Investigational Site 31001
Majadahonda-Madrid, , Spain
Teva Investigational Site 31003
Valencia, , Spain
Teva Investigational Site 31004
Valencia, , Spain
Teva Investigational Site 58011
Cherkasy, , Ukraine
Teva Investigational Site 58013
Dnipropetrovsk, , Ukraine
Teva Investigational Site 58014
Donetsk, , Ukraine
Teva Investigational Site 58017
Khmelnytskyi, , Ukraine
Teva Investigational Site 58010
Kyiv, , Ukraine
Teva Investigational Site 58012
Kyiv, , Ukraine
Teva Investigational Site 58015
Kyiv, , Ukraine
Teva Investigational Site 58016
Simferopol, , Ukraine
Countries
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Other Identifiers
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NHL-TL011-102
Identifier Type: -
Identifier Source: org_study_id