Clinical trial · Interventional
Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia
Phase III Study of Vincristine Sulfate Liposome Or Vincristine Sulfate For Injection Combined Chemotherapy as Initial Induction Regimen In Adults Acute Lymphoblastic Leukemia
- 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)
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.
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 |
|---|---|---|---|
| Adult Acute Lymphoblastic Leukemia | Adult Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vincristine Sulfate | Drug | Vincristine | ALIAS |
| Vincristine Sulfate Liposome | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vincristine Sulfate Liposome
- description
- 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.
- interventionNames
- Drug: Vincristine Sulfate Liposome
- type
- ACTIVE_COMPARATOR
- label
- Vincristine Sulfate
- description
- 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.
- interventionNames
- Drug: Vincristine Sulfate
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 1. Total bilirubin ≤2 ULN (corrected for same age) 2. AST and ALT ≤3 ULN ( corrected for same ages) 3. Serum creatinine ≤2 ULN (corrected for same age) * 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: * Atopy or allergic to multiple medicines or excipients. * With serious complications that affect compliance. * Serious organ dysfunctions or central nervous system disorders. * Mixed phenotype acute leukemia, (T-B). * Burkitt lymphoma/leukemia. * Suspected or confirmed central nervous system leukemia. * Diabetes. * Received antifungal treatment with triazole agents within 1 month before inclusion. * Reliance of antipyretic and analgesic medicines or psychotropic medicines. * Undergoing or has undergone other clinical trials in 4 weeks before inclusion. * Pregnant women, women of breast feeding or childbearing potential without contraception. * Psychological disorders that affect signing consent. * The investigators believe that patients who are not suitable for inclusion.
References
Publications (0)
Data not yet available