Clinical trial · Interventional
Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma
Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma: An Open, Single-center, Phase II Randomized Controlled Clinical Study
NCT04797182CI-TRIAL-00050645unknownPhase 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)
This phase 2 trial studies the efficacy and safety of Avatrombopag for the primary prevention of thrombocytopenia induced by cytarabine-based chemotherapy in patients with lymphoma
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cytarabine Causing Adverse Effects in Therapeutic Use | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| avatrombopag | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- blank control
- description
- No intervention aiming at preventing thrombocytopenia will be taken after first cycle. Avatrombopag as salvage treatment will be administered to patients suffering from thrombocytopenia with nadir platelet count \< 50 × 109/L at a dose of 60mg/day until there is drug-withdrawal indication.
- interventionNames
- Drug: avatrombopag
- type
- EXPERIMENTAL
- label
- primary prevention
- description
- As the primary prevention of thrombocytopenia induced by cytarabine-based chemotherapy, Avatrombopag will be administered at a dose of 60mg/day on days -3\~-1 and 3\~9, for a total of 10 doses. On the condition that patients have platelet counts \<50 × 10 9 /L before next cycle, Avatrombopag will be administered at a dose of 60mg/day until there is drug-withdrawal indications. Platelet transfusions were administered to patients when the platelet count was less than 10×109 /L. Drug-withdrawal indications: PLT ≥ 100×109/L during salvage treatment or platelet count increases by 50×109/L, comparing with baseline level. When platelet count is higher than 400×109/L during this study, researchers determine whether avatrombopag is discontinued
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed lymphoma; * Patients are scheduled to receive cytarabine-based chemotherapy including Ara-C at dose of 4g/m2. * Eastern Cooperative Oncology Group (ECOG) of 0-1; * Proper functioning of the major organs: 1) The absolute value of neutrophils (\>1.5×10\^9/L); platelet count (\> 100×10\^9/L); Hemoglobin (\> 90 g/L); 2) Serum total bilirubin \< 1.5 times ULN; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \< 3 times ULN;3) Serum creatinine \<1.5 times Upper Limit Normal (ULN) ; 4) Coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT)\< 1.5 times ULN * Able to use oral drugs * Patients volunteer to sign an informed consent * Life expectancy \> 3 months; * Contraceptives are used Exclusion Criteria: * Thrombocytopenia unrelated to chemotherapy during six months before screening, including but not limited to hypersplenism, infection and hemorrhage. * In addtion to CIT caused by lymphoma and chemotherapy,patients also suffer from other blood diseases including ALL, AML, myeloid neoplasms, MDS, myeloproliferative disorders, MM; * A thrombosis of a coronary artery or vein developed during three months before screening; * Haemorrhage with severe clinical symptoms, such as gastrointestinal and cerebral hemorrhage; * Platelet transfusion during two days before randomization; * Allergic to avatrombopag; * Participation in any other research about novel agents or devices; * Pregnant or breastfeeding women; * Researchers consider it unsuitable for patients to participate in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.