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

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jun Zhu
• Collaborators: Air Force General Hospital of the PLA; Anhui Provincial Hospital; Beijing Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Chinese PLA General Hospital; First Hospitals affiliated to the China PLA General Hospital; Peking Union Medical College Hospital; Peking University First Hospital; Peking University People's Hospital; Peking University Third Hospital; Zhejiang University
• Treatments: Crizotinib

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