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

December 28, 2016 updated by: Jun Zhu

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Weiping Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • CHOP chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete remission rate
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2 years
2 years
disease-free survival
Time Frame: 2 years
2 years
objective response rate
Time Frame: 2 years
2 years
incidence of >/Grade 3 non-hematology toxicity adverse events
Time Frame: 2 years
2 years
QOL assessment
Time Frame: 2 years
using a battery of cognitive and quality-of-life (QoL) measures
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jun Zhu

Collaborators

Peking University First Hospital
Peking University People's Hospital
Peking Union Medical College Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese PLA General Hospital
Peking University Third Hospital
Beijing Hospital
Zhejiang University
Anhui Provincial Hospital
Air Force General Hospital of the PLA
First Hospitals affiliated to the China PLA General Hospital

Investigators

  • Study Chair: Jun Zhu, MD, Peking University Cancer Hospital & Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

December 30, 2016

Last Update Submitted That Met QC Criteria

December 28, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKU-2015052005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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