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Клинические исследования в Украине

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Описание
Краткое названиеA Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
Полное названиеA Phase Ib, Double Blind RCT to Evaluate and Compare the PK, PD and Safety of MabThera?® With TL011, in Combination With CHOP, in Subjects With CD20+ DLBCL
СпонсорTeva Pharmaceutical Industries
Industry
ИсточникTeva Pharmaceutical Industries
Под контролемHungary: National Institute of Pharmacy
Yes
Краткое описаниеThis is a prospective international, multi-center, randomized, double-blind controlled
study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety
of MabThera?® and TL011, in combination with CHOP in previously untreated patients with
diffuse large B cell lymphoma.
СостояниеИдет набор
Дата началаSeptember 2010
ФазаPhase 1
Вид исследованияAllocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large B
cell non-Hodgkin's lymphoma (DLBCL) based on the 2008 World Health Organization
classification.

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:

1. Any lymphoma other than CD20+ DLBCL

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.
ПолBoth
Минимальный возраст18 Years
Максимальный возраст80 Years
УсловиеDiffuse Large B-cell Lymphoma
Применяемое лечение
BiologicalTL011
BiologicalRituximab
Контакты и расположение
Cherkasy Teva Investigational Site 58011
Dnipropetrovsk Teva Investigational Site 58013
Donetsk Teva Investigational Site 58014
Kyiv Teva Investigational Site 58012
Kyiv Teva Investigational Site 58015
Kyiv Teva Investigational Site 58010
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