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

Primary Purpose

Systemic Anaplastic Large-Cell Lymphoma

Status

Withdrawn

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

crizotinib

About this trial

This is an interventional treatment trial for Systemic Anaplastic Large-Cell Lymphoma focused on measuring Anaplastic Large Cell Lymphoma, anaplastic lymphoma kinase rearrangement, crizotinib, CHOP chemotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Weiping Liu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

crizotinib combined with chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

complete remission rate

Secondary Outcome Measures

disease-free survival

overall survival

objective response rate

incidence of >/Grade 3 non-hematology toxicity adverse events

QOL assessment

using a battery of cognitive and quality-of-life (QoL) measures

Full Information

NCT ID

NCT02487316

First Posted

June 30, 2015

Last Updated

December 28, 2016

Sponsor

Jun Zhu

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

1. Study Identification

Unique Protocol Identification Number

NCT02487316

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Withdrawn

Study Start Date

July 2015 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jun Zhu

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Anaplastic Large-Cell Lymphoma

Keywords

Anaplastic Large Cell Lymphoma, anaplastic lymphoma kinase rearrangement, crizotinib, CHOP chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

crizotinib combined with chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

crizotinib

Other Intervention Name(s)

CHOP chemotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

complete remission rate

Time Frame

2 years

Secondary Outcome Measure Information:

Title

disease-free survival

Time Frame

2 years

Title

overall survival

Time Frame

2 years

Title

objective response rate

Time Frame

2 years

Title

incidence of >/Grade 3 non-hematology toxicity adverse events

Time Frame

2 years

Title

QOL assessment

Description

using a battery of cognitive and quality-of-life (QoL) measures

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Zhu, MD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Weiping Liu

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

25559471

Citation

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.

Results Reference

result

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

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