Clinical trial · Interventional
Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma
A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma
NCT00290433CI-TRIAL-00047291completedPhase 2Results postedClinicalTrials.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 goal of this clinical research study is to learn if treatment with two types of chemotherapy combinations can help to control 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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ara-C | Drug | Cytarabine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxil | Drug | Doxorubicin | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Mesna | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HCVIDDOXIL Regimen
- description
- Cycle 1: Cyclophosphamide by vein two times a day on Days 1,2, and 3. Mesna by vein nonstop over Days 1 through 3. Pegylated liposomal doxorubicin by vein over 1 hour on Day 2. Vincristine by vein on Days 4 and 11. Dexamethasone by mouth on Days 1 through 4 and 11 through 14. Cycle 2: Methotrexate by vein over 2 hours on Day 1 and over 22 hours on day 1. Cytarabine by vein twice a day on Days 2 and 3.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Mesna
- Drug: Vincristine
- Drug: Methotrexate
- Drug: Ara-C
- Drug: Dexamethasone
- Drug: G-CSF
- Drug: Doxil
Primary outcomes (1)
- measure
- 3 Year Progression-Free Survival Rate
- timeFrame
- From registration to disease progression or death, up to 3 years
- description
- Percentage of participants out of total treated alive with disease progression 3 years following registration. Progression-free survival (PFS) was measured from the date of study registration to the date of documented disease progression or death of any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed diagnosis of previously untreated T-cell Non Hodgkin's Lymphomas and NK lymphomas, with the exception of cluster of differentiation antigen 30 (CD30+) alk1+ T-anaplastic large cell lymphoma (ALCL). Patients with skin involvement alone are also excluded. For patients with skin involvement as part of systemic disease, prior topical treatment only is allowed. 2. Patients with a performance status of 3 or less (Zubrod Scale - see Appendix D). 3. Serum bilirubin \</= 1.5 mg/dl and serum creatinine \</= 2.0 mg/dl unless due to lymphoma; Absolute neutrophil count (ANC) \>/= 1000 mm\^3 and platelets \>/= 100,000 mm\^3 unless due to lymphoma. 4. Cardiac ejection fraction 50% or greater by multigated radionuclide angiography (MUGA) or echocardiogram. 5. Ages 18 and older. 6. Patients must be willing to receive transfusions of blood products. Exclusion Criteria: 1. Patients with CD30+ alk1+ T-anaplastic large cell lymphoma (ALCL) or patients with skin involvement alone. 2. Pregnancy 3. HIV positive serology 4. Central nervous system (CNS) involvement 5. Co-morbid medical, such as Child's Class C liver cirrhosis, end-stage renal disease, and symptomatic congestive heart failure, or psychiatric illnesses that preclude treatment with intense dose chemotherapy as determined by the primary investigator 6. Concurrent or previous malignancy whose prognosis is poor (\<90% probability of survival at 5 years)
References
Publications (1)
- RESULTChihara D, Pro B, Loghavi S, Miranda RN, Medeiros LJ, Fanale MA, Hagemeister FB, Fayad LE, Romaguera JE, Samaniego F, Neelapu SS, Younes A, Fowler NH, Rodriguez MA, Wang M, Kwak LW, McLaughlin P, Dang NH, Oki Y. Phase II study of HCVIDD/MA in patients with newly diagnosed peripheral T-cell lymphoma. Br J Haematol. 2015 Nov;171(4):509-16. doi: 10.1111/bjh.13628. Epub 2015 Aug 10. PMID 26260306