Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
cycolophosphamide, vacristine, and pednisone x6 cycles followed by tositumomab and iodine I 131 tositumomab · 1 trial · 1 indication
Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass \>1.5 centimeters in the greatest transverse diameter that has regressed by \>75%, indeterminate bone marrow, are present), or Partial Response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).
CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass \>1.5 centimeters in the greatest transverse diameter that has regressed by \>75%, indeterminate bone marrow, are present. PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations \>=4 weeks apart.
| Arm | Type | Description |
|---|---|---|
| open-label, single arm | EXPERIMENTAL | cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab. CVP will be repeated every 21 days for a total of six cycles. tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of the sixth cycle of CVP. Patient will undergo two dosing phase for the tositumomab and iodine I 131 tositumomab therapy. |
| Name | Type | Description |
|---|---|---|
| cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab. | BIOLOGICAL | cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab. CVP will be repeated every 21 days for a total of six cycles. tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of the sixth cycle of CVP. Patient will undergo two dosing phase for the tositumomab and iodine I 131 tositumomab therapy. |
Inclusion Criteria: * Subjects must have a histologically confirmed initial diagnosis of low-grade non-Hodgkin's B-cell lymphoma according to the International Working Formulation (IWF) (32) (i.e., small lymphocytic with or without plasmacytoid differentiation; follicular small cleaved cell; or fol...
This regimen is used to treat untreated low-grade non-Hodgkin lymphoma. It combines six cycles of CVP chemotherapy followed by tositumomab and iodine I 131 tositumomab, a monoclonal antibody-based therapy. The treatment was studied in a Phase 2 trial for patients with this type of lymphoma.
The regimen is being developed by GSK plc, which trades under the ticker GSK. GSK conducted the clinical trial evaluating this combination in non-Hodgkin lymphoma.
The regimen is in Phase 2 development. It is investigational and has been tested in a completed Phase 2 trial. It is not approved by the FDA for this indication.
The regimen was evaluated in a single Phase 2 clinical trial, NCT01663714, titled "Open Label Multicenter Study of CVP Followed by Iodine-131 Anti-B1 Antibody for Subjects With Untreated Low-Grade Non Hodgkin's Lymphoma." The trial is completed and enrolled 30 participants.