Phase III Study of Compound Formula Realgar-Indigo Naturalis Plus Imatinib Versus Placebo Plus Im… (NCT01755325) | Clinical Trial Compass
SuspendedPhase 3
Phase III Study of Compound Formula Realgar-Indigo Naturalis Plus Imatinib Versus Placebo Plus Imatinib in Adult CML-CP Patients With Ph+
Stopped: not enough patients
China680 participantsStarted 2012-11
Plain-language summary
It is an open-label, randomized, double blind, placebo-controlled parallel-group, multi-center study to evaluate the efficacy and safety of Compound realgar formula Realgar-Indigo naturalis Tablet combined with Imatinib will be compared with imatinib alone in adult patients with diagnosed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia in the chronic phase (CML-CP).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female patients, age \>= 18 years and \<= 75 years.
✓. Eastern Cooperative Oncology Group （ECOG） performance status (PS) score 0, 1, or 2.
✓. Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome positive.(Ph+ CML-CP)
✓. Ph+ Chronic myelogenous leukemia in chronic phase patients within the first 12 months of diagnosis.
✓. Adequate end organ function as defined by:
Exclusion criteria
✕. . Treatment with Busulfan within 1 day prior to study entry.
✕. . Treatment with interferon-alpha within 2 days prior to study entry.
✕. . Treatment with hydroxyurea within 1 day prior to study entry.
✕. . Treatment with homoharringtonine within 14 days prior to study entry.
✕
What they're measuring
1
To compare the rate of Major molecular response（MMR） at 12 months
Timeframe: 12 months of follow-up from the start of treatment