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Comparison · NCT00306202-4f1fc595

Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) vs Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2): Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML)

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) vs Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2): Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML). Trial comparisons, record NCT00306202-4f1fc595. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00306202-4f1fc595

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.250.07150.591wilson
Risk in group 20.6670.3540.879wilson
Risk difference, group 1 minus group 2-0.417-0.6940.0456newcombe hybrid score
Risk ratio, group 1 over group 20.3750.1041.36log
Odds ratio, group 1 over group 20.1670.02011.38log
Number needed to treat, for one fewer participant with the outcome on Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) than on Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)2.4from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Stratum 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.
28OG000
Group 2Stratum 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.
69OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Major Molecular Response (MMR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML)
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.
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])
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.

Source ClinicalTrials.gov

Trial

Title
Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia
NCT number
NCT00306202
Phases
PHASE1
Conditions
Leukemia
Interventions
Dasatinib, Dasatinib, Dasatinib
Lead sponsor
Bristol-Myers Squibb
Results first posted
2012-07-23

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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