Clinical trial · Interventional
Anlotinib for Advanced and Refractory Natural Killer /T-cell Lymphoma
A Pilot Study of Anlotinib for the Evaluation of Safety and Efficacy in Patients With Stage IV Natural Killer/T-cell Lymphoma and Refractory to L-asparaginase Based Chemotherapy
NCT03618238CI-TRIAL-00053873completedPhase 2ClinicalTrials.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 evaluate the efficacy and safety of anlotinib in patients with stage IV extranodal natural killer/T-cell lymphoma, nasal type.
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 |
|---|---|---|---|
| Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anlotinib
- description
- patients will be given anlotinib 12 mg daily for continus 14 days every 21 days until disease progression.
- interventionNames
- Drug: Anlotinib
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- 12 weeks after the initiation of anlotinib treatment
- description
- The treatment response will be assessed every 12 weeks.
Secondary outcomes (1)
- measure
- Treatment-Related Adverse Events as Assessed by CTCAE v4.0
- timeFrame
- Day 1 of each course and then every 3 months for 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type. * stage IV disease and resistant to L-asparaginase-based combined chemotherapy.(Definition of L-asparaginase resistance: Progression during treatment or no response to treatment). * Eastern Cooperative Oncology Group (ECOG ) performance status 0\~3. * Preserved organ functions for: absolute neutrophil counter (ANC)\>1.0×109/L, Platelet\>50×109/L, hemoglobin\>80g/L, total bilirubin (TBIL)\<2×ULN, alanine transaminase (ALT)\<2×ULN, normal serum creatinine，fibrinogen≥1.0g/L, LVEF≥50%. * Signed Informed consented. Exclusion Criteria: * patients with a disease resistant to L-asparaginase but may benefit from a radiotherapy. * HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml. * Significant complications: autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis, disseminated intravascular coagulation, uncontrolled hypertension or diabetes, hemorrhagic or thrombotic events within 6 months. * Mental disorders. * Pregnant or lactation * Peptic ulcer * Enrolled in other trial treatment
References
Publications (0)
Data not yet available
No reference posted for this study.