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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Systemic Anaplastic Large-Cell Lymphoma

Intervention / Treatment
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* Drug: crizotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: crizotinib combined with chemotherapy<br>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<br>* 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.<br>* Other names: CHOP chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate |  | 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anaplastic Large Cell Lymphoma, anaplastic lymphoma kinase rearrangement, crizotinib, CHOP chemotherapy