Clinical trial NCT02487316: A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
Official title: A Multicenter Prospective Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Systemic Anaplastic Large-Cell Lymphoma
Keywords: Anaplastic Large Cell Lymphoma
anaplastic lymphoma kinase rearrangement
crizotinib
CHOP chemotherapy
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Peking University People's Hospital
name: Peking University Third Hospital
name: Peking Union Medical College Hospital
name: Beijing Hospital
name: Chinese PLA General Hospital
name: First Hospitals affiliated to the China PLA General Hospital
name: Air Force General Hospital of the PLA
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Anhui Provincial Hospital
name: Zhejiang University
First posted: 2015-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: complete remission rate
timeFrame: 2 years
Secondary outcomes:
measure: disease-free survival
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
measure: objective response rate
timeFrame: 2 years
measure: incidence of >/Grade 3 non-hematology toxicity adverse events
timeFrame: 2 years
measure: QOL assessment
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Weiping Liu
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu, MD
role: STUDY_CHAIR
References:
citation: 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. Epub 2015 Jan 6.