Clinical trial · Interventional
Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated PTCL
Randomized Phase II Study to Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated Peripheral T-cell Lymphoma
NCT02445404CI-TRIAL-00047840unknownPhase 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 study is a Randomized Phase II Study to Compare Efficacy of CHOP versus Fractionated ICED in Transplant-eligible Patients with Previously Untreated Peripheral T-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 |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHOP | Drug | — | UNRESOLVED |
| fractionated ICED | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CHOP
- description
- cyclophosphamide, 750mg/m² IV day1 doxorubicin, 50 mg/m² IV day1 vincristine, 1.4 mg/m² (max 2 mg) IV day1 prednisone ,40 mg/m² PO day1\~5 every 3 weeks
- interventionNames
- Drug: CHOP
- Drug: fractionated ICED
- type
- EXPERIMENTAL
- label
- Fractionated ICED
- description
- ifosfamide, 1.67 g/m² IV day1\~3 carboplatin, AUC =5 IV day1 etoposide, 100mg/m² IV day1\~3 dexamethasone 40 mg PO or IV day1\~4 every 3 weeks
- interventionNames
- Drug: CHOP
- Drug: fractionated ICED
Primary outcomes (1)
- measure
- progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 19-65 years 2. Informed consent 3. Subject able to adhere to the study visit schedule and other protocol requirements. 4. Histologically proven Peripheral T-cell Lymphoma,No prior chemotherapy for the treatment of Peripheral T-cell Lymphoma It includes the following subtypes. * PTCL, not otherwise specified * Angioimmunoblastic T-cell lymphoma * Anaplastic large cell lymphoma, ALK-negative type * Enteropathy-associated T-cell lymphoma * Hepato-splenic T-cell lymphoma * Subcutaneous panniculitis-like T-cell lymphoma * Primary cutaneous gamma-delta T-cell lymphoma * Primary cutaneous CD8+ aggressive epidermotropic lymphoma * Other non classifiable T-cell Lymphoma 5. Performance status (ECOG) 0,1 or 2 6. A negative pregnancy test prior to treatment must be available both for pre-menopausal women 7. Female of childbearing potential (FCBP) must: contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on IP; and for 3 months following the last dose of IP.Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 3 months following IP discontinuation. 8. life expectancy≥90day(3months) Exclusion Criteria: 1. Other serious medical illnesses or psychiatric disorders 2. Any state that the confusion in the interpretation of test result. 3. Other type lymphoma ex) B-cell lymphoma 4. Other type T-cell lymphoma * Adult T-Cell Leukemia/Lymphoma * NK/T-cell Lymphoma, Nasal Type * ALK-Positive Anaplastic Large-Cell Lymphoma * Cutaneous Tcell lymphoma * primary cutaneous CD30+ lympho- proliferative disorder * primary cutaneous Anaplastic T cell lymphoma 5. Previously treated for PTCL(Except for a short period before randomization of corticosteroids (a period of not more than 8 days) 6. Previous radiation therapy 7. CNS involvement. 8. If the contraindication to chemoherapy 9. Subject has known historical or active infection with HIV. 10. BM function: ANC \< 1.5 × 109/L; Platelet count \<100,000/mm2 (100 × 109/L), SGOT/AST or SGPT/ALT ≥ 3.0 x ULN, Bilirubin\> 2 x upper normal value 11. serum creatinine level \> 2.0 x ULN 12. Any other malignancies within the past 3 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 13. MUGA scan \<45% 14. Those who administered doxorubicin exceeding 200 mg / m2 15. Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 16. Breast-feeding or pregnant female
References
Publications (0)
Data not yet available
No reference posted for this study.