Systemic Anaplastic Large-Cell Lymphoma
Conditions
Keywords
Anaplastic Large Cell Lymphoma, anaplastic lymphoma kinase rearrangement, crizotinib, CHOP chemotherapy
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.
Interventions
DRUGcrizotinib
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.
Sponsors
Peking University First Hospital
Peking University People's Hospital
Peking University Third Hospital
Peking Union Medical College Hospital
Beijing Hospital
Chinese PLA General Hospital
First Hospitals affiliated to the China PLA General Hospital
Air Force General Hospital of the PLA
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Anhui Provincial Hospital
Zhejiang University
Jun Zhu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 years | using a battery of cognitive and quality-of-life (QoL) measures |
Countries
China
Outcome results
None listed