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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Recruitment Status : Withdrawn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

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.

Condition or disease Intervention/treatment Phase
Systemic Anaplastic Large-Cell Lymphoma Drug: crizotinib Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Prospective Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
Study Start Date : July 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. complete remission rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. disease-free survival [ Time Frame: 2 years ]
  2. overall survival [ Time Frame: 2 years ]
  3. objective response rate [ Time Frame: 2 years ]
  4. incidence of >/Grade 3 non-hematology toxicity adverse events [ Time Frame: 2 years ]
  5. QOL assessment [ Time Frame: 2 years ]
    using a battery of cognitive and quality-of-life (QoL) measures



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487316


Locations
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China, Beijing
Weiping Liu
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Jun Zhu
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
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Study Chair: Jun Zhu, MD Beijing Cancer Hospital

Publications of Results:
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Responsible Party: Jun Zhu, Department of Hematology Oncology, clinical oncology college, Director of department, Party Secretary, Peking University
ClinicalTrials.gov Identifier: NCT02487316     History of Changes
Other Study ID Numbers: PKU-2015052005
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: December 30, 2016
Last Verified: December 2016

Keywords provided by Jun Zhu, Peking University:
Anaplastic Large Cell Lymphoma
anaplastic lymphoma kinase rearrangement
crizotinib
CHOP chemotherapy

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action