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cycolophosphamide, vacristine, and pednisone x6 cycles followed by tositumomab and iodine I 131 tositumomab

Phase 2

Lymphoma, Non-Hodgkin | Monoclonal antibody | Oncology |GSK plc|Last Updated: Jan 11, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

cycolophosphamide, vacristine, and pednisone x6 cycles followed by tositumomab and iodine I 131 tositumomab · 1 trial · 1 indication

Phase 2 1
NCT01663714Open Label Multicenter Study of CVP Followed by Iodine-131 Anti-B1 Antibody for Subjects With Untreated Low-Grade Non Hodgkin's Lymphoma.Lymphoma, Non-Hodgkin
COMPLETED30 Analytics
PHASE2COMPLETED
Open Label Multicenter Study of CVP Followed by Iodine-131 Anti-B1 Antibody for Subjects With Untreated Low-Grade Non Hodgkin's Lymphoma.
Lymphoma, Non-Hodgkin
NCT0166371430
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Study Endpoints

Primary Endpoints

Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as Assessed by the Investigator
Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

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).

Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator
Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.

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.

Secondary Endpoints

Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator
Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator
Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
Duration of Response (DOR), as Assessed by the Investigator
Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
open-label, single armEXPERIMENTALcycolophosphamide, 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.

Interventions

NameTypeDescription
cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab.BIOLOGICALcycolophosphamide, 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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...

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