Trial · NCT00306202
Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia
NCT00306202, Phase 1, Completed, Bristol-Myers Squibb; results first posted 2012-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia. Trials, record NCT00306202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00306202
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia
- NCT number
- NCT00306202
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 63 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Leukemia
- Interventions
- Dasatinib, Dasatinib, Dasatinib
- First posted
- 2006-03-23
- Last updated
- 2021-02-26
- Other registries' IDs
- eudract:2005-002882-35
- Results first posted
- 2012-07-23
Source ClinicalTrials.gov
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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]) | The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels. |
| 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]) | AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 3 = Severe; Grade 4 = Life-threatening or disabling. |
| 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]) | DLTs: AEs which were at least possibly drug-related occurring within first 3 weeks of dasatinib therapy (toxicities occurring after 21 days were also considered) and are:- --Any nonhematologic clinically-apparent toxicity of Grade(GR)≥3 occurring despite appropriate medical management and GR4 laboratory abnormality/GR3 lasting ≥7 days --GR4 neutropenia or thrombocytopenia lasting ≥7 days and not explained by the presence of leukemia after hematopoietic reconstitution --Any clinically important toxicity of GR≥2 requiring treatment discontinuation or interruption ≥7 days. |
| 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]) | GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. WBC: GR1=\<LLN-3.0\*10\^9/L; GR2=\<3.0-2.0\*10\^9/L; GR3=\<2.0-1.0\*10\^9/L; GR4=\<1.0\*10\^9/L. ANC: GR1=\<LLN-1.5\*10\^9 /L; GR2=\<1.5-1.0\*10\^9/L; GR3=\<1.0-0.5\*10\^9/L; GR4=\<0.5\*10\^9/L. Hemoglobin: GR1=\<LLN-10.0g/dL; GR2=\<10.0-8.0g/dL; GR3=\<8.0-6.5g/dL; GR4=\<6.5g/dL. Platelets: GR1=\<LLN-75.0\*10\^9/L; GR2=\<75.0-50.0\*10\^9/L; GR3=\<50.0-25.0\*10\^9/L; GR4=\<25.0\*10\^9/L. |
| 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]) | GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. Low calcium: GR1=\<LLN-8.0 mg/dL, GR2=\<8.0-7.0 mg/dL, GR3=\<7.0-6.0 mg/dL, GR4=\<6.0 mg/dL; Low magnesium: GR1=\<LLN-1.2 mg/dL, GR2=\<1.2-0.9 mg/dL, GR3=\<0.9-0.7 mg/dL, GR4=\<0.7 mg/dL; Low phosphate: GR1=\<LLN - 2.5 mg/dL, GR2=\<2.5 - 2.0 mg/dL, GR3=\<2.0 - 1.0 mg/dL, GR4=\<1.0 mg/dL. |
| 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]) | GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Normal ranges provided by local laboratory and may also vary from site to site. AST and ALT: GR1=\>ULN-2.5\*ULN; GR2=\>2.5-5.0\*ULN; GR3=\>5.0-20.0\*ULN; GR4:\>20.0\*ULN. Total bilirubin:GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3-10\*ULN, GR4=\>10\*ULN. Creatinine: GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3.0-6.0\*ULN, GR4=\>6.0\*ULN. |
| 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]) | Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that is either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM. |
| 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) | Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM. |
| 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]) | Best CyR was assessed based on the percentages of Ph+ metaphases of ≥20 analyzed metaphases in BM sample. Participants with complete, partial, minor, minimal, or no CyR. Refer to Outcome Measure 7 for definitions of CCyR and PCyR. Minor CyR:\>35%-65% Ph+ cells in metaphase in BM. Minimal CyR:\>65%-95% Ph+ cells in metaphase in BM. No CyR:\>95%-100% Ph+ cells in metaphase in BM. Unable to determine:Participants without valid cytogenetic assessment (i.e., at least 1 metaphase observed and number of Ph+ metaphases smaller than total number of metaphases \[%Ph+ \<100%\]). |
| 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]) | Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM. |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 registered outcomesOutcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 outcomesResults by group889
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 60 | mg/m^2 QD | ||
| Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia | Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 80 | mg/m^2 QD | ||
| Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia | Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | NA | mg/m^2 QD | ||
| 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. | Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | Drug-Related Deaths | 0 | participants | |
| 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. | Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | Drug-Related Deaths | 0 | participants | |
| 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. | Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2) | Drug-Related Deaths | 0 | participants | |
| 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. | Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2) | Drug-Related Deaths | 0 | participants | |
| 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. | Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2) | Drug-Related Deaths | 0 | participants | |
| 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. | Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2) | Drug-Related Deaths | 0 | participants | |
| 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. | Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2) | Drug-Related Deaths | 0 | participants |
1 to 10 of 889Source ClinicalTrials.gov
See all 889 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 17 | |
| Overall Study | STARTED | Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 17 | |
| Overall Study | STARTED | Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | 24 | |
| Overall Study | COMPLETED | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 17 | |
| Overall Study | COMPLETED | Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 17 | |
| Overall Study | COMPLETED | Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | 24 | |
| Overall Study | NOT COMPLETED | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 0 | |
| Overall Study | NOT COMPLETED | Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 0 | |
| Overall Study | NOT COMPLETED | Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | 0 |
Source ClinicalTrials.gov
Adverse events759
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 1 | 17 | |
| other | Neutropenia | Blood and lymphatic system disorders | Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 1 | 17 | |
| other | Neutropenia | Blood and lymphatic system disorders | Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | 0 | 24 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 1 | 17 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 0 | 17 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | 0 | 24 | |
| other | Splenomegaly | Blood and lymphatic system disorders | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 0 | 17 | |
| other | Splenomegaly | Blood and lymphatic system disorders | Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 0 | 17 | |
| other | Splenomegaly | Blood and lymphatic system disorders | Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | 2 | 24 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 1 | 17 |
1 to 10 of 759Source ClinicalTrials.gov
See all 759 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | ||
| Total, all-cause mortality | Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | ||
| Total, all-cause mortality | Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | ||
| Total, other adverse events | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 16 | 17 |
| Total, other adverse events | Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 16 | 17 |
| Total, other adverse events | Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | 24 | 24 |
| Total, serious adverse events | Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 8 | 17 |
| Total, serious adverse events | Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 14 | 17 |
| Total, serious adverse events | Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | 22 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23715577 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
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) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00306202
GET https://conductscience.org/api/trials/v1/NCT00306202/registered?page=2