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

Systemic Anaplastic Large-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02487316
• Other study ID #: PKU-2015052005
• Status: Withdrawn
• Phase: Phase 4
• First received: June 30, 2015
• Last updated: December 28, 2016
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin
• Systemic Anaplastic Large-Cell Lymphoma

Intervention

Drug:
• crizotinib
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.

Locations

Country	Name	City	State
China	Weiping Liu	Beijing	Beijing

Sponsors (12)

Lead Sponsor

Collaborator

Jun Zhu

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

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission rate		2 years	Yes
Secondary	disease-free survival		2 years	No
Secondary	overall survival		2 years	No
Secondary	objective response rate		2 years	No
Secondary	incidence of >/Grade 3 non-hematology toxicity adverse events		2 years	Yes
Secondary	QOL assessment	using a battery of cognitive and quality-of-life (QoL) measures	2 years	Yes