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A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib

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ClinicalTrials.gov Identifier: NCT02487316
Recruitment Status : Withdrawn
First Posted : July 1, 2015
Last Update Posted : December 30, 2016
Sponsor:
Collaborators:
Peking University First Hospital
Peking University People's Hospital
Peking University Third Hospital
Peking Union Medical College Hospital
Beijing Hospital
Chinese PLA General Hospital
First Hospitals affiliated to the China PLA General Hospital
Air Force General Hospital of the PLA
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Anhui Provincial Hospital
Zhejiang University
Information provided by (Responsible Party):
Jun Zhu, Peking University

Tracking Information
First Submitted Date  ICMJE June 30, 2015
First Posted Date  ICMJE July 1, 2015
Last Update Posted Date December 30, 2016
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
complete remission rate [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02487316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
  • disease-free survival [ Time Frame: 2 years ]
  • overall survival [ Time Frame: 2 years ]
  • objective response rate [ Time Frame: 2 years ]
  • incidence of >/Grade 3 non-hematology toxicity adverse events [ Time Frame: 2 years ]
  • QOL assessment [ Time Frame: 2 years ]
    using a battery of cognitive and quality-of-life (QoL) measures
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
Official Title  ICMJE A Multicenter Prospective Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
Brief Summary The purpose of this study is to determine the efficacy and safety of crizotinib combined with CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.
Detailed Description ALK(+) Systemic Anaplastic Large Cell Lymphoma patients are treated with crizotinib when they receive CHOP chemotherapy. crizotinib 250mg twice a day is administrated from day 1 of chemotherapy to 18 weeks. standard CHOP chemotherapy (cyclophosphamide, 750mg per square meter of body-surface area,d1, vincristine, 1.4mg per square meter of body-surface area, maximal dose is 2mg d1, doxorubicin, 50mg per square meter of body-surface area d1, plus prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Systemic Anaplastic Large-Cell Lymphoma
Intervention  ICMJE Drug: 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 Name: CHOP chemotherapy
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: crizotinib
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 28, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2015)
20
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • primary ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy without therapy
  • 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:

  • Age <\ 18years
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02487316
Other Study ID Numbers  ICMJE PKU-2015052005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jun Zhu, Peking University
Study Sponsor  ICMJE Jun Zhu
Collaborators  ICMJE
  • Peking University First Hospital
  • Peking University People's Hospital
  • Peking University Third Hospital
  • Peking Union Medical College Hospital
  • Beijing Hospital
  • Chinese PLA General Hospital
  • First Hospitals affiliated to the China PLA General Hospital
  • Air Force General Hospital of the PLA
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Anhui Provincial Hospital
  • Zhejiang University
Investigators  ICMJE
Study Chair: Jun Zhu, MD Beijing Cancer Hospital
PRS Account Peking University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP