Phase 2
N=53
Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00290433 ↗Enrolled (actual)
53
Serious AEs
1.9%
Results posted
Sep 2020
Primary outcome: Primary: 3 Year Progression-Free Survival Rate — 30 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclophosphamide (Drug); Mesna (Drug); Vincristine (Drug); Methotrexate (Drug); Ara-C (Drug); Dexamethasone (Drug); G-CSF (Drug); Doxil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 3 Year Progression-Free Survival Rate |
30 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- Patients with a performance status of 3 or less (Zubrod Scale - see Appendix D).
- Serum bilirubin /= 1000 mm^3 and platelets >/= 100,000 mm^3 unless due to lymphoma.
- Cardiac ejection fraction 50% or greater by multigated radionuclide angiography (MUGA) or echocardiogram.
- Ages 18 and older.
- Patients must be willing to receive transfusions of blood products.
Exclusion Criteria
- Patients with CD30+ alk1+ T-anaplastic large cell lymphoma (ALCL) or patients with skin involvement alone.
- Pregnancy
- HIV positive serology
- Central nervous system (CNS) involvement
- 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
- Concurrent or previous malignancy whose prognosis is poor (<90% probability of survival at 5 years)
Data sourced from ClinicalTrials.gov (NCT00290433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.