TriangleNCT02421939 · OUTCOME
Duration of Remission
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of first response until the date of documented relapse for participants who achieved CRc or PR (median time of follow-up was 17.8 months)
What was measured
Duration of remission included duration of CRc, CR/CRh, CRh, CR, CRi, CRp (defined as the time from the date of first CRc until the date of first documented relapse for participants who achieved CRc, CR/CRh, CRh, CR, CRi, CRp respectively) and duration of response (CRc + PR). CRc: achieved CR, CRp or CRi at the visit. CR: BM regenerating normal hematopoietic cells, morphologic leukemia-free state, ANC ≥1x10\^9/L, platelet count ≥100x10\^9/L, normal marrow differential with \<5% blasts, and RBC/platelet transfusion independent with no extramedullary leukemia. CRp: achieved CR except incomplete platelet recovery (\<100x 0\^9/L). CRi: criteria for CR fulfilled except incomplete hematological recovery with residual neutropenia \<1x10\^9/L with /without complete platelet recovery. PR: BM regenerating normal hematopoietic cells, peripheral recovery, no circulating blasts and decrease of 50% blasts in with total blasts between 5% -25% or, 5% if Auer rods present.
Analysis population: The analysis population was the ITT, Duration of CR was only applicable to participants with best overall response of CR.
Groups in this outcome
Gilteritinib
Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
Salvage Chemotherapy
Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).
| Group | Source count |
|---|---|
| Gilteritinib | 52 |
| Salvage Chemotherapy | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gilteritinib | 14.8 | Not reported | 11.0 | NA | Not estimable. Data could not be estimated due to low number of events. |
| Salvage Chemotherapy | 1.8 | Not reported | NA | NA | Not estimable. Data could not be estimated due to low number of events. |
Source statistical analyses
- ci Lower Limit
- 0.022
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.886
- estimate Comment
- Based on Cox proportional hazards model. Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.1189
- p Value Comment
- Unstratified
- param Type
- Hazard Ratio (HR)
- param Value
- 0.206
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.022
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.886
- estimate Comment
- Based on Cox proportional hazards model. Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.1189
- p Value Comment
- Unstratified
- param Type
- Hazard Ratio (HR)
- param Value
- 0.206
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Not estimable. Data could not be estimated due to low number of events.
- group Id
- OG000
- lower Limit
- 11.0
- upper Limit
- NA
- value
- 14.8
- comment
- Not estimable. Data could not be estimated due to low number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 1.8
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- Duration of remission included duration of CRc, CR/CRh, CRh, CR, CRi, CRp (defined as the time from the date of first CRc until the date of first documented relapse for participants who achieved CRc, CR/CRh, CRh, CR, CRi, CRp respectively) and duration of response (CRc + PR). CRc: achieved CR, CRp or CRi at the visit. CR: BM regenerating normal hematopoietic cells, morphologic leukemia-free state, ANC ≥1x10\^9/L, platelet count ≥100x10\^9/L, normal marrow differential with \<5% blasts, and RBC/platelet transfusion independent with no extramedullary leukemia. CRp: achieved CR except incomplete platelet recovery (\<100x 0\^9/L). CRi: criteria for CR fulfilled except incomplete hematological recovery with residual neutropenia \<1x10\^9/L with /without complete platelet recovery. PR: BM regenerating normal hematopoietic cells, peripheral recovery, no circulating blasts and decrease of 50% blasts in with total blasts between 5% -25% or, 5% if Auer rods present.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
- id
- OG000
- title
- Gilteritinib
- description
- Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).
- id
- OG001
- title
- Salvage Chemotherapy
- param Type
- MEDIAN
- population Description
- The analysis population was the ITT, Duration of CR was only applicable to participants with best overall response of CR.
- reporting Status
- POSTED
- time Frame
- From the date of first response until the date of documented relapse for participants who achieved CRc or PR (median time of follow-up was 17.8 months)
- title
- Duration of Remission
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice