None listed
Conditions
Interventions
Amifostine 910mg / m2 EV + Cyclophosphamide 750 mg / m2 EV + Doxorubicin 50 mg / m2 EV + Vincristine 1.4 mg / m2 EV + Prednisone 100 mg / day for 5 days VO with hydration and antiemesis every 3-4 weeks, up to a maximum of 6 courses
Group name:Arm B Type of group
Cyclophosphamide 750 mg / m2 EV + Doxorubicin 50 mg / m2 EV + Vincristine 1.4 mg / m2 EV + Prednisone 100 mg / day for 5 days OV with hydration and antiemesis every 3-4 weeks, up to a maximum of 6 courses
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Age> 69 years • Performance status 0.1 (ECOG scale) • Non-Hodgkin lymphoma of the following subtypes: (WHO classification): - Diffuse large cell B lymphoma - Peripheral T-cell lymphoma - Anaplastic T cell lymphoma - Follicular lymphoma Grade III - Mantle lymphoma (except the blastoid variety) • Advanced stage: defined as IB (tumor> 10 cm) and all stages II, III, IV. • Adequate reserve of bone marrow RAN> 1500; plaq> 100,000; Hb> 12 gr% • Normal function of the liver and kidney (within 2.5 X the normal upper limit) • LVEF> 50% or above the institutional normal (Echocardiogram)
Exclusion criteria
Exclusion criteria: • Previous chemotherapy, previous radiotherapy or previous biological response modifiers. • Patients with CNS lymphoma (positive CSF cytology). • Patients with HIV infection. • Patients who are receiving chronic steroid therapy that has been discontinued <1 week before inclusion, or that require ongoing therapy between courses of chemotherapy. • Previous history of heart disease: myocardial infarction, congestive heart failure within the last 6 months, active heart disease, hypotension or uncontrolled hypertension. • Active infections or diseases that make the administration of chemotherapy or patient compliance impossible. • A second eo-existing malignancy or history within 5 years of previous malignancy (excluding basal or squamous cell skin cancer or cervical carcinoma ECI treated with curative criteria). • Patients with a previous history of liver disease; ex.- Active Chronic Hepatitis, Cirrhosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Incidence of grade 4 neutropenia associated with fever and / or infections requiring antibiotic therapy. Measure:Hematological toxicity Timepoints:During and at the end of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:neutrophil count in blood count Measure:Need to delay, reduce or discontinue the dose of chemotherapy due to the impossibility of recovering the neutrophil count in 1500 / mm3 on the first day of the next cycle. Timepoints:On the first day of each cycle ; Outcome name:Days in hospitalization due to neutropenic complications Measure:Days in hospitalization due to neutropenic complications Timepoints:At the end of the treatment ; Outcome name:Days with antibiotics due to neutropenic complications Measure:Days with antibiotics due to neutropenic complications Timepoints:At the end of the treatment ; Outcome name:Incidence and cumulative dose of vincristine at the beginning of paresthesias grade 2 or greater, or loss of neurological function Measure:Neurotoxicity Timepoints:During the treatment | — |
Contacts
Public ContactOscar Barrenechea
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed