TriangleNCT00274781 · OUTCOME
Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- Not reported
- Time frame
- at 12 weeks post treatment
What was measured
The null hypothesis to be tested was the percentage who will respond to combination arsenic trioxide (ATO) and gemtuzumab ozogamicin (GO) therapy is \<10%. A total of \>/= 9 responses observed in 30 evaluable patients was taken as evidence warranting further study of the regimen, provided the toxicity profile also appears favorable. The IWG Criteria standardizes the clinical responses in MDS and AML based upon hematologic improvement, quality of life and cytogenic improvement. These standardizations allow for the responses to be determined as either complete responses or partial responses.
Analysis population: Responses According to IWG MDS Criteria (n=30) Responses According to IWG AML Criteria (n=12)
Groups in this outcome
ATO + GO
Arsenic Trioxide 0.25 mg/kg D1-5 Week 1/Twice Weekly W2-12 + Gemtuzumab Ozogamicin 3 mg/m\^2 D8 for 1 or 2 Cycles of 12 Weeks each arsenic trioxide: Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12). gemtuzumab ozogamicin: Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion
| Group | Source count |
|---|---|
| ATO + GO | 30 |
Reported measurements
Responses according to IWG MDS Criteria
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ATO + GO | 30 | Not reported | Not reported | Not reported | Not reported |
Responses according to IWG AML Criteria
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ATO + GO | 25 | Not reported | Not reported | Not reported | Not reported |
Responses according to Both Criteria
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ATO + GO | 10 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 30
- title
- Responses according to IWG MDS Criteria
- categories
- measurements
- group Id
- OG000
- value
- 25
- title
- Responses according to IWG AML Criteria
- categories
- measurements
- group Id
- OG000
- value
- 10
- title
- Responses according to Both Criteria
- denoms
- counts
- group Id
- OG000
- value
- 30
- units
- Participants
- description
- The null hypothesis to be tested was the percentage who will respond to combination arsenic trioxide (ATO) and gemtuzumab ozogamicin (GO) therapy is \<10%. A total of \>/= 9 responses observed in 30 evaluable patients was taken as evidence warranting further study of the regimen, provided the toxicity profile also appears favorable. The IWG Criteria standardizes the clinical responses in MDS and AML based upon hematologic improvement, quality of life and cytogenic improvement. These standardizations allow for the responses to be determined as either complete responses or partial responses.
- groups
- description
- Arsenic Trioxide 0.25 mg/kg D1-5 Week 1/Twice Weekly W2-12 + Gemtuzumab Ozogamicin 3 mg/m\^2 D8 for 1 or 2 Cycles of 12 Weeks each arsenic trioxide: Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12). gemtuzumab ozogamicin: Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion
- id
- OG000
- title
- ATO + GO
- param Type
- NUMBER
- population Description
- Responses According to IWG MDS Criteria (n=30) Responses According to IWG AML Criteria (n=12)
- reporting Status
- POSTED
- time Frame
- at 12 weeks post treatment
- title
- Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)
- type
- PRIMARY
- unit Of Measure
- percentage of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice