TriangleNCT00306202 · OUTCOME
Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])
What was measured
Molecular response was calculated by measuring BCR-ABL transcripts in blood during treatment using qPCR assay. MMR: Ratio of the BCR-ABL to ABL \<10\^-3 or a ≥3 log reduction from baseline in participants with p190 variant; ratio of the BCR-ABL to ABL \<10\^-3 on the international scale in participants with p210 variant. BCR-ABL=the fused gene found in participants with this type of CML.
Analysis population: All treated participants (14 with p190 variant and 3 with p210 variant BCR-ABL transcripts) in stratum 2/3: Participants who received at least 1 dose of study therapy.
Groups in this outcome
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)
Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
| Group | Source count |
|---|---|
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 8 |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
| Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Molecular response was calculated by measuring BCR-ABL transcripts in blood during treatment using qPCR assay. MMR: Ratio of the BCR-ABL to ABL \<10\^-3 or a ≥3 log reduction from baseline in participants with p190 variant; ratio of the BCR-ABL to ABL \<10\^-3 on the international scale in participants with p210 variant. BCR-ABL=the fused gene found in participants with this type of CML.
- groups
- description
- Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG000
- title
- Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)
- description
- Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG001
- title
- Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
- param Type
- NUMBER
- population Description
- All treated participants (14 with p190 variant and 3 with p210 variant BCR-ABL transcripts) in stratum 2/3: Participants who received at least 1 dose of study therapy.
- reporting Status
- POSTED
- time Frame
- At baseline (within 3 weeks before initiation of study therapy), After hematologic response, EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])
- title
- Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice