Clinical trial · Interventional
A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma
A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma
NCT03558412CI-TRIAL-00034859unknownPhase 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)
To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic 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 |
|---|---|---|---|
| T-lymphoblastic Lymphoma | T Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CODOX-M/IVAC | Combination Product | — | UNRESOLVED |
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Decitabine+CODOX-M/IVAC for patients with relapsed or refractory T-lymphoblastic lymphoma who used Hyper-CVAD or BFM-90 as first-line therapy:regimen A:CODOX-M:cyclophosphamide,epirubicin,vincristine,methotrexate.Regimen B :IVAC:ifosfamide,etoposide,cytarabine.Decitabine,10mg,ivgtt,used for 5 days before A+B.
- interventionNames
- Combination Product: CODOX-M/IVAC
- Drug: Decitabine
Primary outcomes (2)
- measure
- RR
- timeFrame
- up to 2 months
- description
- Responder Rate
- measure
- TTP
- timeFrame
- up to 2 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * age: 14\~60 years; ECOG rate ≤ 2; expected survival \> 3 months; * patients with T-lymphoblastic lymphoma diagnosed by histopathology detection; * patients ever received chemotherapy and/or radiotherapy;and can not be transplanted hematopoietic stem cells; * patients with no chemotherapy contraindications: hemoglobin ≥ 90 g/L, absolute neutrophil count ≥1.5 x 109/L, blood platelet ≥100 x 109/L, ALT and AST ≤ 2-fold upper normal limit, serum bilirubin ≤ 1.5-fold upper normal limit, serum creatinine ≤ 1.5-fold upper normal limit, serum albumin ≥ 30 g/L, normal serofibrinogen; * at least one measurable nidus; * no other severe diseases conflict with this project, cardiopulmonary function is basically normal; * the urine or blood pregnancy test of women in childbearing age must be negative in 7 days before follow-up visit; * applicable for follow-up visit; * no other antitumor adjoint therapy (including antitumor Chinese medicine, immunotherapy and biotherapy), but double phosphate anti-bone transfer therapy and other symptomatic treatment are acceptable; * understanding this study and assigning informed consent. Exclusion Criteria: * rejecting providing blood preparation; * allergic to drug in this study and with metabolic block; * rejecting adopting reliable contraceptive method in pregnancy or lactation period; * uncontrolled internal medicine disease (including uncontrolled diabetes, severe incompetence cardiac, lung, liver and pancreas); * with severe infection; * with primary or secondary central nervous system tumor invasion; * with immunotherapy or radiotherapy contraindication; * ever suffered with malignant tumor; * having peripheral nervous system disorder or dysphrenia; * with no legal capacity, medical or ethical reasons affecting research proceeding; * participating other clinical trials simultaneously; * adopting other anti-tumor medicine excluding this research; * the researchers considering it inappropriate to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.