Trial · NCT00038675
Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate
NCT00038675, Not applicable, Completed, M.D. Anderson Cancer Center; results first posted 2022-01-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate. Trials, record NCT00038675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00038675
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate
- NCT number
- NCT00038675
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 125 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Chronic Myelomonocytic Leukemia, Chronic Myeloid Leukemia, Polycythemia Vera, Hypereosinophilic Syndrome, Mastocytosis
- Interventions
- Imatinib Mesylate (Gleevec)
- First posted
- 2002-06-05
- Last updated
- 2022-01-04
- Results first posted
- 2022-01-04
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Complete Response (CR) | after 2 months of therapy, up to 1 year. | Acute myeloid leukemia (AML), Myelodysplastic Syndromes (MDS): CR=Normalization peripheral blood \& bone marrow with 5% or less blasts; normo- or hypercellular marrow; Absolute Neutrophil Count (ANC) \> 1.0 x 10\^9/L, \& platelet count \>100 x 10\^9/L; or CR marrow=As per CR but platelet count \< 100 x 10\^9/L. Agnogenic myeloid metaplasia (AMM) \& CMML: CR=Absence of signs/symptoms of disease; White blood count between 1 to 10 x 10\^9/L with no peripheral blasts, promyelocytes, or myelocytes and normalization of bone marrow (\< 5% blasts in normocellular or hypercellular marrow) for 4+ weeks. PV: CR=normalization of hemoglobin/hematocrit without need for phlebotomies, disappearance all signs/symptoms of disease. HES: CR=disappearance of eosinophilia (\</=10%), disappearance signs/symptoms of disease. Mastocytosis: CR=disappearance of mast cell infiltrates in affected organs, decrease of serum tyrptase levels to \<20 ng/ml, \& disappearance of SM-associated organomegaly. |
| Secondary | Duration of Response | From response evaluation (first evaluation following 2 months therapy) to disease progression or death or until disease progression whichever occurs first, up to 12 years and 5 months | Time from response to disease progression, measuring length of the response in those participants who responded. |
| Secondary | Overall Survival | From the start of therapy to death or disease progression, assessed up to 12 years and 5 months | Overall survival defined as time from registration to disease progression or death from any cause. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Complete Response (CR) | after 2 months of therapy, up to 1 year. | participants | NUMBER | |
| SECONDARY | Duration of Response | From response evaluation (first evaluation following 2 months therapy) to disease progression or death or until disease progression whichever occurs first, up to 12 years and 5 months | Months | MEDIAN | |
| SECONDARY | Overall Survival | From the start of therapy to death or disease progression, assessed up to 12 years and 5 months | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Complete Response (CR) | Imatinib Mesylate | Acute Leukemia | 0 | participants | |
| Number of Participants With a Complete Response (CR) | Imatinib Mesylate | Chronic myeloproliferative disorders (CMPD) | 0 | participants | |
| Number of Participants With a Complete Response (CR) | Imatinib Mesylate | Chronic Myelomonocytic Leukemia (CMML) | 2 | participants | |
| Number of Participants With a Complete Response (CR) | Imatinib Mesylate | Essential Thrombocythemia | 0 | participants | |
| Number of Participants With a Complete Response (CR) | Imatinib Mesylate | Hypereosinophilic syndrome (HES) | 3 | participants | |
| Number of Participants With a Complete Response (CR) | Imatinib Mesylate | Systemic mastocytosis (SM) | 4 | participants | |
| Number of Participants With a Complete Response (CR) | Imatinib Mesylate | Myelodysplastic syndromes (MDS) | 0 | participants | |
| Number of Participants With a Complete Response (CR) | Imatinib Mesylate | Myelofibrosis | 1 | participants | |
| Number of Participants With a Complete Response (CR) | Imatinib Mesylate | Polycythemia Vera (PV) | 2 | participants | |
| Duration of Response | Imatinib Mesylate | 68 | Full Range 33.3 to 149 | Months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imatinib Mesylate | 125 | |
| Overall Study | COMPLETED | Imatinib Mesylate | 125 | |
| Overall Study | NOT COMPLETED | Imatinib Mesylate | 0 |
Source ClinicalTrials.gov
Adverse events7
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 |
|---|---|---|---|---|---|---|
| serious | Death | General disorders | Imatinib Mesylate | 10 | 125 | 10 |
| serious | Hepatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Imatinib Mesylate | 1 | 125 | 1 |
| serious | Herniated disc Surgery | Surgical and medical procedures | Imatinib Mesylate | 1 | 125 | 1 |
| serious | GI Hemorrhage | Gastrointestinal disorders | Imatinib Mesylate | 1 | 125 | 1 |
| serious | Ascites | Gastrointestinal disorders | Imatinib Mesylate | 1 | 125 | 1 |
| serious | Anemia | Blood and lymphatic system disorders | Imatinib Mesylate | 1 | 125 | 1 |
| serious | Second Malignancy (Basal Cell Carcinoma) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Imatinib Mesylate | 1 | 125 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib Mesylate | 10 | 125 |
| Total, other adverse events | Imatinib Mesylate | 0 | 125 |
| Total, serious adverse events | Imatinib Mesylate | 13 | 125 |
Source ClinicalTrials.gov
Papers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00038675
GET https://conductscience.org/api/trials/v1/NCT00038675/registered