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

Phase 4

Withdrawn

• Conditions: Systemic Anaplastic Large-Cell Lymphoma
• Interventions: Drug: crizotinib

• Registration Number: NCT02487316
• Lead Sponsor: Jun Zhu

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 Timeline

• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-06-30
• Study Start: 2015-07
• Study First Posted: 2015-07-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-28
• Last Update Posted: 2016-12-30
• Primary Completion: 2017-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
crizotinib combined with chemotherapy	crizotinib	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.

Primary Outcome Measures

Name	Time	Method
complete remission rate	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Weiping Liu; 🇨🇳 Beijing, Beijing, China