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| Name | Class |
|---|---|
| Ethics Committee of Blood Diseases Hospital | UNKNOWN |
| Guangdong Provincial People's Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
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The purpose of this study is to determine whether vincristine sulfate liposome could reduce less peripheral neuropathy than vincristine sulfate,and be as effective as vincristine sulfate in adults with Naïve Acute Lymphoblastic Leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vincristine Sulfate Liposome | Experimental | Vincristine Sulfate For Injection simulation agent 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection: 1.4mg/m2, (2mg, maximum dose), iv, d1, d8, d15, d22. Duration between these two agents should be more than 2.5h, and saline should be avoided for flushing before Vincristine Sulfate Liposome For Injection. |
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| Vincristine Sulfate | Active Comparator | Vincristine Sulfate For Injection 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection simulation agent: 1.4mg/m2,(2mg, maximum dose), iv, d1, 8, 15, 22. Duration between these two agents should be more than 2.5h, and saline should not be used for flushing before Vincristine Sulfate Liposome For Injection simulation agent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vincristine Sulfate Liposome | Drug |
| ||
| Vincristine Sulfate |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate(objectives (ORR) | ORR=CR+CRi CR(Complete response)
CRi(Complete response with incomplete recovery of counts) Recovery of platelets but<100,000 or ANC is <1000/microl | up to 35 days |
| Incidence of General peripheral neuropathy | Chemotherapy-induced peripheral neuropathy was evaluated By Total Neuropathy Score clinical Version(TNSc). If the score of any item of TNSc at anytime after the start of induction chemotherapy is higher than the baseline,it is considered that peripheral neuropathy occurs. | A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy |
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Inclusion Criteria:
De novo untreated ALL patients diagnosed by the bone marrow morphology, immunophenotype.
65 ≥ Age (years) ≥ 18 , male or female,
ECOG Performance status of 0, 1, or 2.
Patients must fulfill the following laboratory values
Didn't receive any of the following treatments within 4 weeks before inclusion: chemotherapy, radiotherapy, replacement therapy, operation, long term of glucocorticoid therapy(>5 days).
No neurological disorders, no nerve or muscle injury (motor and sensory nerve).
Patient must sign the informed consent and obey the protocol.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingchang Mi, Doctor | Contact | 86-10-22-23909999 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Blood Diseases, Chinese Academy of Medical Sciences | Recruiting | Tianjin | 300020 | China |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
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| Xijing Hospital |
| OTHER |
| Xinqiao Hospital of Chongqing | OTHER |
| China Medical University, China | OTHER |
| West China Hospital | OTHER |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| Xuzhou Medical University | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
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| Drug |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |