Trial · NCT00306202
Outcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia | From the date of first dose to end-of-treatment (EOT) (Median duration of therapy in months: Stratum 1=24.11 [Range:2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | All treated participants: Participants who received at least 1 dose of study therapy | mg/m^2 QD | NUMBER |
| SECONDARY | Number of Participants With Related Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0. | From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | All treated participants: Participants who received at least 1 dose of study therapy. | participants | NUMBER |
| SECONDARY | Number of Participants With Dose-limiting Toxicity (DLT) | From the date of first dose until at least 30 days after the last dose of study drug (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | All treated participants: Participants who received at least 1 dose of study therapy. | participants | NUMBER |
| SECONDARY | Number of Participants With Hematology Abnormalities by NCI CTCAE Version 3.0 | Days 8, 15, 22, 29, 36, 43, then every 3 weeks, then every 3 months after 1 Year, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | All treated participants: Participants who received at least one dose of study therapy. | participants | NUMBER |
| SECONDARY | Number of Participants With Serum Chemistry Abnormalities (Calcium, Magnesium, and Phosphate) by NCI CTCAE Version 3.0 | Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | All treated participants: Participants who received at least one dose of study therapy. | participants | NUMBER |
| SECONDARY | Number of Participants With Serum Chemistry Abnormalities (Liver and Renal Function) by NCI CTCAE Version 3.0 | Days 22 and 43, then every 12 weeks, then every 24 weeks after 24 months of treatment, EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | All treated participants: Participants who received at least one dose of study therapy. | participants | NUMBER |
| SECONDARY | Number of Participants With Major Cytogenetic Response (MCyR) at Any Time in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]) | All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy. | participants | NUMBER |
| SECONDARY | Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks | After completion of Week 12 and 24 (measured at Weeks 13 and 25) | All treated participants in stratum 1: Participants who received at least 1 dose of study therapy. | participants | NUMBER |
| SECONDARY | Best Cytogenetic Response (CyR) in Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Strata 1 and 2/3: At Weeks 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Weeks 4, 19, 25, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]) | All treated participants (strata 1 and 2/3): Participants who received at least 1 dose of study therapy. Stratum 2/3 dasatinib 80 mg/m\^2 dose cohort includes 1 participant as having a CCyR due to a data entry error that was fixed after database lock for this study. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Cytogenetic Response (CCyR) or Major Cytogenetic Response (MCyR) at Recommended Phase II Dose | Strata 1 and 2/3: At Week 7, 13, then every 12 weeks, and EOT; Stratum 2/3: Additionally at Week 4, 19, 31 (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]) | All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy. | percentage of participants | NUMBER |
| SECONDARY | Time to Major Cytogenetic Response (MCyR) in Responders: Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Strata 1 and 2/3: At Weeks 7, 13, 25, 37, then every 12 weeks; Stratum 2/3: Additionally at Weeks 4, 19, 31; until first MCyR (maximum participant time to first MCyR of 92 days). | All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed \& the number of Ph+ metaphases smaller than the total number of metaphases \[%Ph+ \<100%\]) were considered responders. | days | MEDIAN |
| SECONDARY | Duration of Major Cytogenetic Response (MCyR) in Responders (Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML]) | From the date of first MCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 48.6 months) | All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed \& the number of Ph+ metaphases smaller than the total number of metaphases \[%Ph+ \<100%\]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment. | months | MEDIAN |
| SECONDARY | Duration of Complete Cytogenetic Response (CCyR) in Responders: Stratum 1 [Ph+ CP-CML] and Stratum 2/3 [Ph+ ALL or AP/BP-CML] | From the date of first CCyR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 45.1 months) | All treated participants who had cytogenetic response. Participants with at least 1 metaphase observed \& the number of Ph+ metaphases smaller than the total number of metaphases \[%Ph+ \<100%\]) were considered responders. Participants who neither progressed nor died were censored on the date of their last valid cytogenetic assessment. | months | MEDIAN |
| SECONDARY | Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML) | Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; at Week 10 (only stratum 4); then every 12 weeks upto 24 months; then once/year; EOT(Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38]) | All treated participants in strata 2/3 and 4: Participants who received at least 1 dose of study therapy. | participants | NUMBER |
| SECONDARY | Number of Participants With Major Hematologic Response (MaHR) in Stratum 2/3 (Ph+ ALL or AP/BP-CML) Within First 6 and 24 Weeks | After completion of Week 6 and 24 (measured at weeks 7 and 25) | All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy. | participants | NUMBER |
| SECONDARY | Best Hematologic Response (HR) At Any Time: Stratum 1 (Ph+ CP-CML) | Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]) | All treated participants in stratum 1: Participants who received at least 1 dose of study therapy. | participants | NUMBER |
| SECONDARY | Best Hematologic Response (HR) At Any Time: Stratum 2/3 (Ph+ ALL or AP/BP-CML) | Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks up to 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]) | All treated participants in Stratum 2/3: Participants who received at least 1 dose of study therapy. | participants | NUMBER |
| SECONDARY | Best Hematologic Response (HR) At Any Time: Stratum 4 (Ph- ALL/AML) | Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 10, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 4=1.14 [Range: 0.03-3.38]) | All treated participants in stratum 4: Participants who received at least 1 dose of study therapy. | participants | NUMBER |
| SECONDARY | Time to Major Hematologic Response (MaHR): Stratum 2/3 (PH+ ALL or AP/BP-CML) | Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks upto 24 months; then once/year; until confirmed MaHR (maximum participant time to first MaHR of 44 days). | Treated participants with MaHR in stratum 2/3. | days | MEDIAN |
| SECONDARY | Time to Complete Hematologic Response (CHR): Stratum 1 (Ph+ CP-CML) and Stratum 2/3 (Ph+ALL or AP/BP-CML) | Days 8, 15, 22, 29, 36, 43; Weeks 7, 13, 25, 37; at Week 4, 19, 31 (only stratum 2/3); then every 12 weeks upto 24 months; then once/year; until criteria was first met for CHR (maximum participant time to first CHR of 65 days). | All treated participants with CHR in strata 1 and 2/3. | days | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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