Clinical trial · Interventional
Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Peripheral T-Cell Lymphomas
Therapeutic Effect of Chemotherapy Azacytidine Plus CAOLD Regimen on Patients With Relapsed/Refractory Peripheral T-Cell Lymphomas
NCT06176027CI-TRIAL-00082015recruitingPhase 1 / Phase 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 is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with CAOLD Regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Peripheral T-Cell Lymphomas | Peripheral T-Cell Lymphoma, Not Otherwise Specified | CURATED_BROADER | 0.78 |
| Relapsed Peripheral T-Cell Lymphomas | Peripheral T-Cell Lymphoma, Not Otherwise Specified | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacytidine plus CAOLD regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Azacytidine plus CAOLD regimen
- description
- Patients were treated by Azacytidine plus CAOLD regimen
- interventionNames
- Drug: Azacytidine plus CAOLD regimen
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 1 year
- description
- ORR was defined as the proportion of patients who achieved CR or PR as their best response
Secondary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- through study completion, an average of 2 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients must satisfy all following criteria to be enrolled in the study: * Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification; * Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF). * Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted; * Patient is willing and able to adhere to the study visit schedule and other protocol requirements; * Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below.) * Meet the following lab criteria: * Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if bone marrow (BM) involvement by lymphoma) * Platelet ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma) * Hemoglobin ≥ 8 g/dL. * Anticipated life expectancy at least 3 months Exclusion Criteria: * Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment; * Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy; * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.