CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Vincristine Sulfate Liposomes Injection +1 moredrug
Likely dose
Liposomal vincristine intravenously over 60 minutes on Days 1, 8, 15, 22 (±2 days); dexamethasone 40 mg orally or intravenously daily on Days 1-4 and 11-14 (±2 days)AI-extracted
Key inclusion· 5
  • ✓Relapsed or refractory ALL (including lymphoblastic lymphoma and Burkitt's subtypes) with measurable disease
  • ✓ECOG performance status ≤3
  • ✓All ages eligible; those ≥12 years may contribute to Phase I MTD; pediatric patients must be treated at previously-tested adult dose level
  • ✓Adequate liver function (bilirubin ≤2 × ULN) and renal function (creatinine ≤2 × ULN)
Key exclusion· 7
  • ✕Active serious infection not controlled by oral or intravenous antibiotics
  • ✕Chemotherapy or investigational agents within 21 days unless full recovery from side effects or rapidly progressive life-threatening disease
  • ✕Concurrent anti-cancer agents other than dexamethasone
  • ✕CNS leukemia/lymphoma requiring intrathecal or craniospinal radiation or with CNS neuropathy limiting study drug evaluation; controlled CNS disease may be eligible with PI approval

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00144963
NCT00144963Phase 2Completed
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Phase I-II Study of Liposomal Vincristine (VSLI) and Dexamethasone in Relapsed or Refractory Acute Lymphoblastic Leukemia

Acrotech Biopharma Inc.·interventional·Posted Sep 5, 2005·Updated Dec 12, 2019

In Brief

A Phase 2 clinical trial evaluating Vincristine Sulfate Liposomes Injection and Dexamethasone for Acute Lymphoblastic Leukemia. Completed, enrolled 36 participants across 3 sites.

Detailed Summary

The purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartJul 1, 2002
Primary CompletionAug 1, 2006
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.8 years ago

Interventions

Vincristine Sulfate Liposomes Injectiondrug

Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days).

Dexamethasonedrug

Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).