Clinical trial · Interventional
Late Chronic Phase Chronic Myelogenous Leukemia
Therapy of Late Chronic Phase Chronic Myelogenous Leukemia (CML) With High-Dose Gleevec (STI571)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objectives: Primary endpoints: To achieve low levels of Polymerase Chain Reaction (PCR) ratios of B-cell antigen receptor (Bcr-Abl)/Bcr (molecular CR) in a significant proportion of patients after 12 months of higher doses (800 mg daily) of Gleevec therapy To increase the proportion of patients achieving a complete cytogenetic response in patients with Ph-positive chronic phase CML using initial higher dose Gleevec therapy. Secondary endpoints: To evaluate the durations of PCR negativity, cytogenetic response, hematologic control, and survival. To analyze differences in response rates and in prognosis within different risk groups and patient characteristics
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gleevec | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gleevec
- description
- Gleevec 400 mg by mouth (P.O.) twice daily = 800 mg total daily dose
- interventionNames
- Drug: Gleevec
Primary outcomes (1)
- measure
- Cytogenetic Complete Response (CR) Rate
- timeFrame
- Evaluated at 6 months; Polymerase Chain Reaction (PCR) testing for BCR-ABL every 3-4 months in year one then every year.
- description
- CR Rate = Number participants out of total treated with complete cytogenetic response. Complete Hematologic Remission (CHR) - normalization \>4 weeks of bone marrow (less than 5% blasts) \& peripheral blood with white blood count (WBC)\<10x10\^9/L \& no peripheral blasts, promyelocytes or myelocytes, disappearance of all signs \& symptoms of disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly \<50% of pretreatment, or thrombocytosis \>450x10\^9/L but \<50% of pretreatment. Complete hematologic remission further classified according to suppression of Philadelphia chromosome (Ph) by cytogenetics or fluorescence in situ hybridization (FISH): a) No cytogenetic response - Ph positive 100% of pretreatment value; b) Minor cytogenetic response - Ph positive 35-90% of pretreatment value; c) Partial cytogenetic response - Ph positive 1-34% of pretreatment value; d) Complete cytogenetic response - Ph positive 0%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients age 15 years or older with a diagnosis of Ph-positive or Bcr-positive CML in chronic phase CML. They should be in at least one of the categories below: A. Patients must have received interferon alpha and: - Failed to achieve or lost a hematologic complete remission(after 3 months of therapy with interferon), or - Failed to achieve or lost a major cytogenetic remission, or - Failed to achieve or lost a complete molecular remission (competitive quantitative PCR \<0.05%), or - Were intolerant to interferon B. Patients in late chronic phase (i.e., \>/= 12 months from diagnosis) who have not received treatment with interferon and: - Have high risk for toxicity with IFN-A (e.g., age \>/= 60 years), or - Refuse to use IFN-A 2. ECOG performance of 0-2. 3. Serum bilirubin less than 2mg%, serum creatinine less than 2mg%. Exclusion Criteria: 1. \- NYHA Class 3-4 heart disease; Pregnant or lactating females 2. Women of pregnancy potential must practice contraception 3. Patients in accelerated phase (except clonal evolution) or blastic phase are excluded. - Patients with clonal evolution as their only criterion for accelerated phase are eligible. 4. Inclusion of women and minorities: As per NIH policy, women and members of minorities will be included in this protocol as they are referred in the CML population.
References
Publications (0)
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