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not enough patients
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compound realgar natural indigo Tablet | Experimental | Compound realgar natural indigo Tablet, 65mg/kg/d, from day1 to day14,every 4 weeks. imatinib,0.4g,qd |
|
| placebo | Placebo Comparator | placebo tablet,65mg/kg/d, from day1 to day14,every 4 weeks. imatinib 0.4g qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound realgar natural indigo Tablet | Drug | Compound realgar natural indigo Tablet, 65mg/kg/d, from day1 to day14,every 4 weeks. imatinib,0.4g,qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the rate of Major molecular response(MMR) at 12 months | 12 months of follow-up from the start of treatment |
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Inclusion Criteria:
(1). Alanine transaminase(ALT), Aspartate transaminase(AST) <=2.5 x upper limit of normal(ULN).
(2). Total bilirubin <= 1.5 x ULN. (3).Cr <= 1.5 x ULN. (4). Serum amylase and lipase <= 1.5 x ULN. 6. Signed informed consent.
Exclusion Criteria:
1. Previously received or be receiving any of the following medical treatment for CML:
2. Treatment with any tyrosine kinase inhibitor(s) or arsenic reagent prior to study entry 3. Patients who are: (a) pregnant, (b) breast feeding, (c) female or male of childbearing potential unwilling to use contraceptive precautions throughout the trial.
4. Major surgery within 4 weeks prior to randomization or who have not recovered from prior surgery.
5. Patients who have not recovered from toxic reaction of prior similar treatment evaluated by investigators.
6. Impaired cardiac function including any one of the following:
8. Uncontrolled medical conditions:
10. History of chronic pancreatitis or history of acute pancreatitis within 1 year of study entry.
11. Acute or chronic uncontrolled liver disease or severe renal disease considered unrelated to CML.
12. Patients actively receiving therapy with strong CYP3A4 inhibitors, strong CYP3A4 inducers or any medications being potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
13. Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks prior to randomization.
14. Known to be allergic to the study drugs, including crude drug or adjuvant. 15. As investigators evaluate, the patients do not fit to join the study (such as with severe complications) .
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| Name | Affiliation | Role |
|---|---|---|
| Saijuan Chen, M.D. | Runjin Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital medical college Huazhong University of Science and Technology | Wuhan | Hubei | China | |||
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| placebo | Drug |
|
| The NO.1 People's Hospital of Huaian |
| Huaian |
| Jiangsu |
| 223002 |
| China |
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | China |
| First Hospital Affiliated to Suzhou University | Suzhou | Jiangsu | China |
| The FIrst Affiliated Hospital, College of Medicine, Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The Second Affiliated Hospital, College of Medicine, Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The Tumor Hospital of Jiangxi | Nanchang | Jiangxi | 330029 | China |
| The NO.1 Hospital of Nanchang | Nanchang | Jiangxi | 333008 | China |
| The Second Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | China |
| Xijing Hospital-Fourth Military Medical University | Xi'an | Shan'xi | China |
| The FIrst Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | China |
| The People's Hospital of Peking University | Beijing | China |
| Ruijin Hospital | Shanghai | China |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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