Clinical trial · Interventional
A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
A Multicenter Prospective Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
NCT02487316CI-TRIAL-00025300withdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Systemic Anaplastic Large-Cell Lymphoma | Systemic Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| crizotinib | Drug | Crizotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- crizotinib combined with chemotherapy
- 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.
- interventionNames
- Drug: crizotinib
Primary outcomes (1)
- measure
- complete remission rate
- timeFrame
- 2 years
Secondary outcomes (5)
- measure
- disease-free survival
- timeFrame
- 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTBoi 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. PMID 25559471