CompletedPhase 2

Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma

United States55 participantsStarted 2003-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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 \</= 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 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)

What they're measuring

3 Year Progression-Free Survival Rate

Timeframe: From registration to disease progression or death, up to 3 years

Trial details

NCT IDNCT00290433

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07

Results submitted2016-07-27

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