The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).
This is a phase II efficacy trial for patients with untreated, high-risk, B-cell Non-Hodgkin's Lymphoma. The study will evaluate the efficacy and safety of high-dose chemotherapy combined with monoclonal antibodies and targeted radioimmunotherapy in previously untreated patients with high-risk NHL
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2
300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.
375mg/m2 each week x 4 weeks of induction, beginning on day 1
Duke University Medical Center
Durham, North Carolina, United States
1 Year Progression-free Survival Rate
Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: \>50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.
Time frame: 1 year
Disease-free Survival
Disease-free survival is measured from the date of CR or CRu to date of relapse or death
Time frame: 10 years
Overall Survival
Overall Survival is measured from the first day of chemotherapy until death from any cause.
Time frame: 10 years
Overall Response
Percent of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period. CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR = 1. \>/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. 2. No increase should be observed in the size of other nodes, liver, or spleen. 3. Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. 4. Except splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. 5. Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders. 6. No new sites of disease should be observed.
Time frame: up to 1 year
Secondary Malignancies
The number of patients who develop secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.
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3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses
45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation
450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.
Time frame: 10 years