Trial · NCT00978731
Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Study
NCT00978731, Phase 1, Completed, Bristol-Myers Squibb; results first posted 2011-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Study. Trials, record NCT00978731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00978731
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Study
- NCT number
- NCT00978731
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 46 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Leukemia
- Interventions
- Dasatinib
- First posted
- 2009-09-17
- Last updated
- 2011-04-28
- Results first posted
- 2011-04-19
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | AEs: any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to AEs were recorded. These data differ from that in the Participant Flow section. This is because the data were collected on 2 different pages of the Case Report Form and were not reconciled. |
| Primary | Number of Participants Who Experienced Drug-related AEs and Drug-related SAEs. | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | Drug-related AEs are those events with a relationship to the study therapy of certain; probable; or possible or missing. Drug-related SAEs are those events with any relationship to the study therapy. |
| Primary | Number of Participants With Grade 3-4 Hematology Abnormalities | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | Abnormalities were graded per the National Cancer Institute(NCI)Common Toxicity Criteria (CTC), v3.0(Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Hemoglobin: Grade 3:6.5 - \<8.0g/dL, Grade 4: \<6.5g/dL. Platelets: Grade 3: 25.0 - \<50.0\*10\^9/L, Grade 4: \<25.0\*10. Absolute Neutrophil Count (ANC): Grade 3: 0.5 - \<1.0\*10\^9/L, Grade 4: \<0.5\*10\^9/L.White Blood Cells (WBC) : Grade 3: 1.0 - \<2.0\*10\^9/L, Grade 4: \<1.0\*10\^9/L. |
| Primary | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | Abnormalities were graded per the NCI (CTC), v3.0 (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening). Grade 3 and 4 criteria are as follows: Alanine aminotransferase (ALT): Grade 3: 5.0-20.0 \* ULN (upper limit of normal), Grade 4: \>20.0 \* ULN; Calcium: Grade 3: 6.0-\<7.0 or \>12.5-13.5 mg/dL, Grade 4: \<0.6-\>13.5 mg/dL; Bilirubin: Grade 3: \>3-10 \* ULN, Grade 4: \>10 \* ULN; Creatinine: Grade 3: \>3.0-6.0 \* ULN, Grade 4: \>6.0 \* ULN; Albumin: Grade 3: \<2g/dL (Grade 4 not defined in NCI CTC); Magnesium: Grade 3: 0.6-\<0.8 or \>2.46-6.6mEq/L, Grade 4: \<0.6 or \>6.6mEq/L. |
| Primary | Number of Participants With Dose Interruptions and Dose Reductions | From start of study to final assessment (up to 32.2 months). | Dose interruptions and reductions were allowed, in order to optimize individual participant's hematologic, cytogenetic, and molecular response while maintaining and evaluating safety and tolerability of long-term exposure to dasatinib. A dose reduction is defined as the administration of a dose at a lower level compared to previous dose and such that reduced dose, or a lower dose, is given at least 4 consecutive times. In determining the reductions, dose level would be compared to the previous non-null dose. Dose interruption is defined as a complete omission of dosing for 4 consecutive times. |
| Secondary | Number of Participants With Complete Hematologic Response (CHR) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | CHR should meet all of the following criteria: WBC \<= Institutional ULN; ANC \>= 1000/mm\^3 ; Platelets \< 450 000/mm\^3 , no blasts or promyelocytes in peripheral blood; \< 5% myelocytes plus metamyelocytes in peripheral blood; basophils in peripheral blood \< 20% and no extramedullary involvement (including no hepatomegaly or splenomegaly). CHR can begin only 14 days after the start of treatment. |
| Secondary | Median Number of Months of CHR (Kaplan Meier Method) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | CHR: WBC\<=ULN (range: 9.29-12.5\*10\^3 c\\uL); ANC \>=1000/mm\^3;Platelets \<450000/mm\^3,no blasts/promyelocytes in peripheral blood; \<5% myelocytes+metamyelocytes in peripheral blood; basophils in peripheral blood \<20% \& no extramedullary involvement. Duration computed for chronic phase participants, measured in months from first day CHR criteria met, provided they are confirmed 4 weeks later, until progression of disease, treatment discontinuation due to progressive disease or death. Participants who neither discontinue due to progression, nor progress nor die censored on date of last assessment. |
| Secondary | Number of Participants With Major Cytogenetic Response (MCyR) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | Cytogenetic responses are based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. MCyR is defined as number of participants with Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): \>0% to 35% Ph+ cells in metaphase in bone marrow. |
| Secondary | Median Number of Months of Major Cytogenetic Response (MCyR) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | MCyR: 0% Ph+ cells in metaphase in bone marrow or Partial Cytogenetic Response (PCyR): \>0% to 35% Ph+ cells in metaphase in bone marrow.The duration of MCyR was computed for chronic phase participants whose best response is either CCyR or PCyR. It was measured in months from the time measurement criteria are first met for CCyR or PCyR (whichever status is recorded first) until the date of progression or death. Participants who neither progress nor die are censored on the date of their last cytogenetic assessment. |
| Secondary | Number of Participants With Best Cytogenetic Response | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | Cytogenetic responses are based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. CCyR: 0% Ph+ cells in metaphase in bone marrow, PCyR: \>0% to 35% Ph+ cells in metaphase in bone marrow, Minor CyR: \>35% to 65% Ph+ cells in metaphase in bone marrow, Minimal CyR: \>65% to 95% Ph+ cells in metaphase in bone marrow and No CyR: \>95% to 100% Ph+ cells in metaphase in bone marrow. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. | participants | NUMBER |
| PRIMARY | Number of Participants Who Experienced Drug-related AEs and Drug-related SAEs. | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. | participants | NUMBER |
| PRIMARY | Number of Participants With Grade 3-4 Hematology Abnormalities | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. | participants | NUMBER |
| SECONDARY | Number of Participants With Complete Hematologic Response (CHR) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. Data was not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes. | participants | NUMBER |
| SECONDARY | Median Number of Months of CHR (Kaplan Meier Method) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants with CML (whether QD or BID dosing), who had CHR. Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes. | months | MEDIAN |
| SECONDARY | Number of Participants With Major Cytogenetic Response (MCyR) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable. | participants | NUMBER |
| PRIMARY | Number of Participants With Grade 3-4 Serum Chemistry Abnormalities | From start of study until up to 30 days after end of study participation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants. | participants | NUMBER |
| SECONDARY | Median Number of Months of Major Cytogenetic Response (MCyR) | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants with CML (whether QD or BID dosing), who had MCyR (13 participants had MCyR in QD group and 9 in BID group). Data were not analyzed and reported for the other two groups (Accelerated Phase CML and Myeloid Blast Phase CML) due to small sample sizes. | months | MEDIAN |
| PRIMARY | Number of Participants With Dose Interruptions and Dose Reductions | From start of study to final assessment (up to 32.2 months). | All treated participants. | participants | NUMBER |
| SECONDARY | Number of Participants With Best Cytogenetic Response | Pre-treatment to study discontinuation. Median duration of exposure (on-study time) was 23.4 months. | All treated participants with evaluable sample sizes. Data was not analyzed and reported for the Accelerated Phase CML and Myeloid Blast Phase CML groups due to small sample sizes, which would lead to response rate estimates that are not stable. | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | Deaths | 3 | participants | |
| Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | CML: BID Dosing at Study Entry | Deaths | 2 | participants | |
| Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | Accelerated Phase CML: BID Dosing at Study Entry | Deaths | 1 | participants | |
| Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | Myeloid Blast Phase CML: BID Dosing at Study Entry | Deaths | 1 | participants | |
| Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | SAEs | 10 | participants | |
| Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | CML: BID Dosing at Study Entry | SAEs | 9 | participants | |
| Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | Accelerated Phase CML: BID Dosing at Study Entry | SAEs | 3 | participants | |
| Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | Myeloid Blast Phase CML: BID Dosing at Study Entry | SAEs | 3 | participants | |
| Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | AEs | 22 | participants | |
| Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation. | CML: BID Dosing at Study Entry | AEs | 15 | participants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | 22 | |
| Overall Study | STARTED | CML: BID Dosing at Study Entry | 15 | |
| Overall Study | STARTED | Accelerated Phase CML: BID Dosing at Study Entry | 5 | |
| Overall Study | STARTED | Myeloid Blast Phase CML: BID Dosing at Study Entry | 4 | |
| Overall Study | COMPLETED | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | 0 | |
| Overall Study | COMPLETED | CML: BID Dosing at Study Entry | 0 | |
| Overall Study | COMPLETED | Accelerated Phase CML: BID Dosing at Study Entry | 0 | |
| Overall Study | COMPLETED | Myeloid Blast Phase CML: BID Dosing at Study Entry | 0 | |
| Overall Study | NOT COMPLETED | Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry | 22 | |
| Overall Study | NOT COMPLETED | CML: BID Dosing at Study Entry | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events640
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 | EYE PRURITUS | Eye disorders | Participants With Accelerated Phase CML | 0 | 5 | |
| other | EYE PRURITUS | Eye disorders | Participants With Chronic Myelogenous Leukemia(CML);QD Dosing | 0 | 22 | |
| other | EYE PRURITUS | Eye disorders | Participants With CML; BID Dosing | 1 | 15 | |
| other | EYE PRURITUS | Eye disorders | Participants With Myeloid Blast Phase CML | 0 | 4 | |
| other | VISION BLURRED | Eye disorders | Participants With Accelerated Phase CML | 0 | 5 | |
| other | VISION BLURRED | Eye disorders | Participants With Chronic Myelogenous Leukemia(CML);QD Dosing | 0 | 22 | |
| other | VISION BLURRED | Eye disorders | Participants With CML; BID Dosing | 1 | 15 | |
| other | VISION BLURRED | Eye disorders | Participants With Myeloid Blast Phase CML | 0 | 4 | |
| other | OCULAR HYPERAEMIA | Eye disorders | Participants With Accelerated Phase CML | 0 | 5 | |
| other | OCULAR HYPERAEMIA | Eye disorders | Participants With Chronic Myelogenous Leukemia(CML);QD Dosing | 0 | 22 |
1 to 10 of 640Source ClinicalTrials.gov
See all 640 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With Accelerated Phase CML | ||
| Total, all-cause mortality | Participants With Chronic Myelogenous Leukemia(CML);QD Dosing | ||
| Total, all-cause mortality | Participants With CML; BID Dosing | ||
| Total, all-cause mortality | Participants With Myeloid Blast Phase CML | ||
| Total, other adverse events | Participants With Accelerated Phase CML | 5 | 5 |
| Total, other adverse events | Participants With Chronic Myelogenous Leukemia(CML);QD Dosing | 21 | 22 |
| Total, other adverse events | Participants With CML; BID Dosing | 15 | 15 |
| Total, other adverse events | Participants With Myeloid Blast Phase CML | 4 | 4 |
| Total, serious adverse events | Participants With Accelerated Phase CML | 3 | 5 |
| Total, serious adverse events | Participants With Chronic Myelogenous Leukemia(CML);QD Dosing | 10 | 22 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry vs Participants With CML: BID Dosing at Study Entry: Number of Participants With Major Cytogenetic Response (MCyR) |
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/NCT00978731
GET https://conductscience.org/api/trials/v1/NCT00978731/results?page=2