A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
NCT ID: NCT02487316
Last Updated: 2016-12-30
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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WITHDRAWN
PHASE4
INTERVENTIONAL
2015-07-31
2017-12-31
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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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crizotinib combined with chemotherapy
crizotinib 250mg, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
crizotinib
crizotinib 250mg, oral, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
Interventions
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crizotinib
crizotinib 250mg, oral, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG 0-2
* more than 1 measurable lesions with major axis \>1.5cm and minor axis\>1.0cm
* estimated survival \>/3months
* Age 18-65 years
* Women of childbearing age should have a negative pregnancy test; men and women who need to agree to use effective contraception during the period of treatment and the following 1 years
* Signature of informed consent
Exclusion Criteria
* without ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy
* without measurable lesions
* being treated by other drugs in other clinical trials
* Pregnant or lactating women, who are not willing to take contraceptive measures during the study period, or are not willing to use effective contraceptive measures during the period of treatment and the following 1 years
* Hepatic insufficiency: serum total bilirubin, ALT more than 2 times higher than normal
* Renal insufficiency: more than 2 times higher than that of normal serum creatinine
* Blood screening period: WBC \< 1 \* 109/L \* 109/L; platelet \< 25; Hb \< 60g/L
* HIV test positive
18 Years
65 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Peking University People's Hospital
OTHER
Peking University Third Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Beijing Hospital
OTHER_GOV
Chinese PLA General Hospital
OTHER
First Hospitals affiliated to the China PLA General Hospital
OTHER_GOV
Air Force General Hospital of the PLA
OTHER_GOV
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Anhui Provincial Hospital
OTHER_GOV
Zhejiang University
OTHER
Jun Zhu
OTHER
Responsible Party
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Jun Zhu
Department of Hematology Oncology, clinical oncology college, Director of department, Party Secretary
Principal Investigators
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Jun Zhu, MD
Role: STUDY_CHAIR
Peking University Cancer Hospital & Institute
Locations
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Weiping Liu
Beijing, Beijing Municipality, China
Countries
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References
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Boi M, Zucca E, Inghirami G, Bertoni F. Advances in understanding the pathogenesis of systemic anaplastic large cell lymphomas. Br J Haematol. 2015 Mar;168(6):771-83. doi: 10.1111/bjh.13265. Epub 2015 Jan 6.
Other Identifiers
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PKU-2015052005
Identifier Type: -
Identifier Source: org_study_id