NCT00038675 · OUTCOME
Number of Participants With a Complete Response (CR)
Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate · Source last updated 2022-01-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- after 2 months of therapy, up to 1 year.
What was measured
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.
Groups in this outcome
Imatinib Mesylate
Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Imatinib Mesylate | 125 |
|---|
Reported measurements
Acute Leukemia
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib Mesylate | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Chronic myeloproliferative disorders (CMPD)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib Mesylate | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Chronic Myelomonocytic Leukemia (CMML)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib Mesylate | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Essential Thrombocythemia
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib Mesylate | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Hypereosinophilic syndrome (HES)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib Mesylate | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Systemic mastocytosis (SM)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib Mesylate | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Myelodysplastic syndromes (MDS)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib Mesylate | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Myelofibrosis
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib Mesylate | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Polycythemia Vera (PV)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Imatinib Mesylate | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Acute Leukemia
- title
- Chronic myeloproliferative disorders (CMPD)
- title
- Chronic Myelomonocytic Leukemia (CMML)
- title
- Essential Thrombocythemia
- title
- Hypereosinophilic syndrome (HES)
- title
- Systemic mastocytosis (SM)
- title
- Myelodysplastic syndromes (MDS)
- title
- Myelofibrosis
- title
- Polycythemia Vera (PV)
- description
- 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.
- groups
- description
- Imatinib mesylate 400 mg orally daily, HES participants start with 100 mg orally daily.
- id
- OG000
- title
- Imatinib Mesylate
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- after 2 months of therapy, up to 1 year.
- title
- Number of Participants With a Complete Response (CR)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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