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
2 other identifiers
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lymphoma
Started Sep 2003
Longer than P75 for phase_2 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 10, 2006
CompletedFirst Posted
Study publicly available on registry
February 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
September 23, 2020
CompletedSeptember 23, 2020
September 1, 2020
11.8 years
February 10, 2006
July 27, 2016
September 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
3 Year Progression-Free Survival Rate
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.
From registration to disease progression or death, up to 3 years
Study Arms (1)
HCVIDDOXIL Regimen
EXPERIMENTALCycle 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.
Interventions
Cycle 1: 300 mg/m\^2 by vein Over 3 Hours Twice Daily on Days 1, 2, and 3.
Cycle 1 and 2: 200 mg/m\^2 by vein Over 2 Hours on Day 1, followed by 800 mg/m\^2 IV Over 22 Hours on Day 1.
Cycle 1 and 2: 3 Gm/m\^2 Over 2 Hours Twice Daily On Days 2 and 3.
Cycle 1: 40 mg by vein or by mouth daily on Days 1-4 and 11-14.
Cycle 1 and 2: 300 or 480 mcg subcutaneously 24 hours after end of Day 4 vincristine.
Cycle 1: 25 mg/m\^2 by vein Over 1 Hour on Day 2.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Ortho Biotech, Inc.collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Chihara 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: 26260306RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Flowers/Chair, Lymphoma-Myeloma
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Yasuhiro Oki, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2006
First Posted
February 13, 2006
Study Start
September 1, 2003
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
September 23, 2020
Results First Posted
September 23, 2020
Record last verified: 2020-09