Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01563055 | A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia | PHASE2 | COMPLETED | 10 | — | — | Apr 1, 2012 | Nov 1, 2014 | Aug 10, 2015 | 6 | Japan |
Tolerability of ofatumumab in combination with chlorambucil was evaluated based on the number of participants who developed toxicity requiring discontinuation from study treatment during Cycle 1. The treatment was considered tolerable when 0 of 3 participants, or \<=2 of 6 participants developed toxicity which required discontinuation of study treatment during Cycle 1. The toxicity requiring discontinuation was determined based on the pre-defined withdrawal criteria.
Response evaluated as per International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-sponsored Working Group (NCI-WG) Guidelines, 2008. Overall response rate (ORR) is defined as percentage of par. achieving complete remission (CR), nodular partial remission (nPR), CR-incomplete (CRi) or PR. CR (\>=2 months after last treatment): lymphocytes (LC) \<4000 per microliter (μL), no lymphadenopathy (Ly)\>1.5 cm/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils (N)\>1500/µL, platelets (PL)\>100,000/µL, hemoglobin (Hb)\>11 grams/deciliter (g/dL), bone marrow (BM) sample must be normocellular for age,\<30% LC, no lymphoid nodule (LN). PR:\>=50% decrease in LC, Ly, size of liver and spleen; and at least one of these: N\>1500/μL, PL\>100,000/µL or 50% improvement over Baseline (BL), Hb\>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity.
| Arm | Type | Description |
|---|---|---|
| ofatumumab + chlorambucil | EXPERIMENTAL | ofatumumab dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days; chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 treatment cycles |
| Name | Type | Description |
|---|---|---|
| chlorambucil, tablets | DRUG | 2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles |
| ofatumumab (GSK1841157) infusion | DRUG | iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days; |
Inclusion Criteria: * Diagnosis of CLL defined by : Circulating B lymphocytes ≥5,000 /μL AND Flow cytometry confirmation of immunophenotype with CD5, CD19, CD20, and CD23 prior to Visit 2. * Considered inappropriate for fludarabine-based therapy * Active disease and indication for treatment based o...