TriangleNCT02907359 · OUTCOME
Disease Response (DR) Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 46.6 months
What was measured
DR: Complete Response(CR), Partial Response(PR),Marrow Complete Response(mCR), and Hematological Improvement(HI) including HI with Erythroid (HI-E), HI with Neutrophil (HI-N), or HI with Platelet (HI-P) based on IWG 2006 criteria. CR: BM:≤5% myeloblasts, Peripheral blood: Hgb≥11g/dL, Platelets(PLTs)≥100x10\^9/L, Neutrophils≥1.0x10\^9/L, Blasts 0%. PR: All CR criteria if abnormal before treatment except BM blasts decreased ≥50% over pretreatment but still\>5%, Cellularity, morphology not relevant. HI responses:1) HI-E: Hgb increase ≥1.5g/dL, Relevant reduction of RBC units transfusions by absolute ≥4 RBC transfusions/8 week(wk) compared with pretreatment transfusion number previous 8wk. Only RBC transfusions given for Hgb≤9.0g/dL. 2) HI-P: Absolute increase≥30x10\^9/L starting\>20x10\^9/L PLTs; Increase from\<20x10\^9/L to\>20x10\^9/L and by≥100%. 3) HI-N: ≥100% increase, absolute increase\>0.5x10\^9/L.
Analysis population: The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Participants who had multiple responses of HI (HI-E, HI-N and HI-P) were counted only once while calculating the total HI value in both treatment groups. Percentage of participants are rounded off to the nearest single decimal point.
Groups in this outcome
Guadecitabine
Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).
Treatment Choice
Participants received one of the three treatment choice options: 1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice. 2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.
| Group | Source count |
|---|---|
| Guadecitabine | 277 |
| Treatment Choice | 140 |
Reported measurements
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 1.4 | Not reported | 0.0 | 2.8 | Not reported |
| Treatment Choice | 0.7 | Not reported | 0.0 | 2.1 | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 0 | Not reported | 0 | 0 | Not reported |
| Treatment Choice | 0 | Not reported | 0 | 0 | Not reported |
Marrow Complete Response (mCR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 17.3 | Not reported | 12.9 | 21.8 | Not reported |
| Treatment Choice | 8.6 | Not reported | 3.9 | 13.2 | Not reported |
Hematological Improvement (HI)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 3.2 | Not reported | 1.2 | 5.3 | Not reported |
| Treatment Choice | 5.7 | Not reported | 1.9 | 9.6 | Not reported |
HI with Erythroid (HI-E)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 1.1 | Not reported | 0.0 | 2.2 | Not reported |
| Treatment Choice | 2.1 | Not reported | 0.0 | 4.5 | Not reported |
HI with Platelet (HI-P)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 1.8 | Not reported | 0.2 | 3.3 | Not reported |
| Treatment Choice | 2.1 | Not reported | 0.0 | 4.5 | Not reported |
HI with Neutrophil (HI-N)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Guadecitabine | 0.7 | Not reported | 0.0 | 1.7 | Not reported |
| Treatment Choice | 2.1 | Not reported | 0.0 | 4.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 2.8
- value
- 1.4
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 2.1
- value
- 0.7
- title
- Complete Response (CR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- title
- Partial Response (PR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.9
- upper Limit
- 21.8
- value
- 17.3
- group Id
- OG001
- lower Limit
- 3.9
- upper Limit
- 13.2
- value
- 8.6
- title
- Marrow Complete Response (mCR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 5.3
- value
- 3.2
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- 9.6
- value
- 5.7
- title
- Hematological Improvement (HI)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 2.2
- value
- 1.1
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 4.5
- value
- 2.1
- title
- HI with Erythroid (HI-E)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 3.3
- value
- 1.8
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 4.5
- value
- 2.1
- title
- HI with Platelet (HI-P)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 1.7
- value
- 0.7
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 4.5
- value
- 2.1
- title
- HI with Neutrophil (HI-N)
- denoms
- counts
- group Id
- OG000
- value
- 277
- group Id
- OG001
- value
- 140
- units
- Participants
- description
- DR: Complete Response(CR), Partial Response(PR),Marrow Complete Response(mCR), and Hematological Improvement(HI) including HI with Erythroid (HI-E), HI with Neutrophil (HI-N), or HI with Platelet (HI-P) based on IWG 2006 criteria. CR: BM:≤5% myeloblasts, Peripheral blood: Hgb≥11g/dL, Platelets(PLTs)≥100x10\^9/L, Neutrophils≥1.0x10\^9/L, Blasts 0%. PR: All CR criteria if abnormal before treatment except BM blasts decreased ≥50% over pretreatment but still\>5%, Cellularity, morphology not relevant. HI responses:1) HI-E: Hgb increase ≥1.5g/dL, Relevant reduction of RBC units transfusions by absolute ≥4 RBC transfusions/8 week(wk) compared with pretreatment transfusion number previous 8wk. Only RBC transfusions given for Hgb≤9.0g/dL. 2) HI-P: Absolute increase≥30x10\^9/L starting\>20x10\^9/L PLTs; Increase from\<20x10\^9/L to\>20x10\^9/L and by≥100%. 3) HI-N: ≥100% increase, absolute increase\>0.5x10\^9/L.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Guadecitabine 60 mg/m\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).
- id
- OG000
- title
- Guadecitabine
- description
- Participants received one of the three treatment choice options: 1. LDAC 20 mg/m\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice. 2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\^2) by IV infusion for 3 days of each 28-day cycles. 3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals. Duration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.
- id
- OG001
- title
- Treatment Choice
- param Type
- NUMBER
- population Description
- The Efficacy Analysis Set included all participants randomly assigned to the study treatment. Participants who had multiple responses of HI (HI-E, HI-N and HI-P) were counted only once while calculating the total HI value in both treatment groups. Percentage of participants are rounded off to the nearest single decimal point.
- reporting Status
- POSTED
- time Frame
- Up to approximately 46.6 months
- title
- Disease Response (DR) Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice