Lymphoma Clinical Trial
Official title:
A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma
Verified date | September 2020 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Ortho Biotech, Inc. |
United States,
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 wit — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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