NCT02287233 · OUTCOME
Best Response Based on IWG Criteria
A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia · Source last updated 2022-08-29
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.
What was measured
Best response determined using the IWG-AML response criteria during the course of treatment.
* CR: ANC ≥ 10\^3 /µL, platelet counts ≥ 10\^5 /µL, RBC transfusion independence, and bone marrow with \< 5% blasts;
* CRi: lack of morphologic evidence of leukemia (blasts \< 5%), and platelet counts \< 10\^5 /µL or ANC \< 10\^3 /µL;
* PR: all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate;
* MLFS: \< 5% blasts in an aspirate and/or bone marrow core sample;
* RD: failure to achieve CR, CRi, PR; only including subjects surviving at least 7 days following completion of initial treatment cycle with evidence of persistent leukemia by blood and/or bone marrow examination;
* PD: one or more of the following: ≥ 50% decrement from maximum response levels in neutrophils or platelets; a reduction in hemoglobin by at least 2 g/dL; or transfusion dependence not due to other toxicities and bone marrow blast ≥ 5%.
Analysis population: All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)
Groups in this outcome
Phase 1+2: 600 mg Venetoclax + LDAC
Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 82 |
|---|
Reported measurements
Source class 1
Complete Remission (CR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete Remission with Incomplete Marrow Recovery (CRi)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial Remission (PR)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Morphologically Leukemia Free State (MLFS)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Resistant Disease (RD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
Disease Progression (PD)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Discontinued With No Response Data (DS)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- title
- Complete Remission (CR)
- title
- Complete Remission with Incomplete Marrow Recovery (CRi)
- title
- Partial Remission (PR)
- title
- Morphologically Leukemia Free State (MLFS)
- title
- Resistant Disease (RD)
- title
- Disease Progression (PD)
- title
- Discontinued With No Response Data (DS)
- description
- Best response determined using the IWG-AML response criteria during the course of treatment.
* CR: ANC ≥ 10\^3 /µL, platelet counts ≥ 10\^5 /µL, RBC transfusion independence, and bone marrow with \< 5% blasts;
* CRi: lack of morphologic evidence of leukemia (blasts \< 5%), and platelet counts \< 10\^5 /µL or ANC \< 10\^3 /µL;
* PR: all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate;
* MLFS: \< 5% blasts in an aspirate and/or bone marrow core sample;
* RD: failure to achieve CR, CRi, PR; only including subjects surviving at least 7 days following completion of initial treatment cycle with evidence of persistent leukemia by blood and/or bone marrow examination;
* PD: one or more of the following: ≥ 50% decrement from maximum response levels in neutrophils or platelets; a reduction in hemoglobin by at least 2 g/dL; or transfusion dependence not due to other toxicities and bone marrow blast ≥ 5%.
- groups
- description
- Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle.
Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
- id
- OG000
- title
- Phase 1+2: 600 mg Venetoclax + LDAC
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)
- reporting Status
- POSTED
- time Frame
- Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.
- title
- Best Response Based on IWG Criteria
- type
- SECONDARY
- unit Of Measure
- Participants
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