Status:
COMPLETED
Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
All of the drugs used in this study are commonly used in the treatment of cancer. However, using these drugs in combination is investigational. During treatment, you will be given two different cycle...
Eligibility Criteria
Inclusion
- 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 \</= 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.
- 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
- 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)
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00290433
Start Date
September 1 2003
End Date
July 1 2015
Last Update
September 23 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030