Lenalidomide in Combination With CHOP in Patients With Untreated PTCL
NCT ID: NCT04423926
Last Updated: 2020-06-16
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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UNKNOWN
PHASE1/PHASE2
91 participants
INTERVENTIONAL
2020-06-10
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lenalidomide+CHOP
Lenalidomide
Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\~d10# 21days a cycle
Cyclophosphamide
Cyclophosphamide 750 mg/m2 d1
Doxorubicin
Doxorubicin 50 mg/m2 d1
Vincristine
Vincristine 1.4mg/m2 (maximum 2mg) d1
Prednisolone
Prednisolone 60mg/m2 d1-5
Interventions
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Lenalidomide
Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\~d10# 21days a cycle
Cyclophosphamide
Cyclophosphamide 750 mg/m2 d1
Doxorubicin
Doxorubicin 50 mg/m2 d1
Vincristine
Vincristine 1.4mg/m2 (maximum 2mg) d1
Prednisolone
Prednisolone 60mg/m2 d1-5
Eligibility Criteria
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Inclusion Criteria
2. ECOG PS 0-2
3. Age 18-70 years old
4. Expected survival ≥ 12 weeks
5. A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm)
6. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
7. Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures
Exclusion Criteria
2. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
3. Patients known to have varicella or herpes zoster virus infection
4. Previous exposure to any anti-tumor therapy
5. Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr# 50 mL/min unless these abnormalities were related to the lymphoma
6. History of DVT or PE within past 12 months
7. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet count less than 75×109/L, unless caused by bone marrow infiltration
8. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome#acute heart failure#severe ventricular arrhythmia
9. CNS or meningeal involvement
10. Known sensitivity or allergy to investigational product
11. Major surgery within three weeks
12. Patients receiving organ transplantation
13. Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer
14. Presence of Grade III nervous toxicity within past two weeks
15. Active and severe infectious diseases
16. Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment
17. In any conditions which investigator considered ineligible for this study.
18 Years
70 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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WEI XU
Professor
Principal Investigators
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Wei Xu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Locations
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The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Hopfinger G, Nosslinger T, Lang A, Linkesch W, Melchardt T, Weiss L, Egle A, Greil R. Lenalidomide in combination with vorinostat and dexamethasone for the treatment of relapsed/refractory peripheral T cell lymphoma (PTCL): report of a phase I/II trial. Ann Hematol. 2014 Mar;93(3):459-62. doi: 10.1007/s00277-014-2009-0. Epub 2014 Jan 18.
Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. doi: 10.1016/j.ejca.2013.04.029. Epub 2013 May 31.
Iqbal J, Wright G, Wang C, Rosenwald A, Gascoyne RD, Weisenburger DD, Greiner TC, Smith L, Guo S, Wilcox RA, Teh BT, Lim ST, Tan SY, Rimsza LM, Jaffe ES, Campo E, Martinez A, Delabie J, Braziel RM, Cook JR, Tubbs RR, Ott G, Geissinger E, Gaulard P, Piccaluga PP, Pileri SA, Au WY, Nakamura S, Seto M, Berger F, de Leval L, Connors JM, Armitage J, Vose J, Chan WC, Staudt LM; Lymphoma Leukemia Molecular Profiling Project and the International Peripheral T-cell Lymphoma Project. Gene expression signatures delineate biological and prognostic subgroups in peripheral T-cell lymphoma. Blood. 2014 May 8;123(19):2915-23. doi: 10.1182/blood-2013-11-536359. Epub 2014 Mar 14.
Schmitz N, de Leval L. How I manage peripheral T-cell lymphoma, not otherwise specified and angioimmunoblastic T-cell lymphoma: current practice and a glimpse into the future. Br J Haematol. 2017 Mar;176(6):851-866. doi: 10.1111/bjh.14473. Epub 2016 Dec 16.
Other Identifiers
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2019-SR-429
Identifier Type: -
Identifier Source: org_study_id
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