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

Jun Zhu

Status and phase: Withdrawn; Phase 4

Conditions: Systemic Anaplastic Large-Cell Lymphoma

Treatments: Drug: crizotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02487316

PKU-2015052005

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

crizotinib combined with chemotherapy

Experimental group

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.

Treatment:

Drug: crizotinib