ON 01910.Na for Intermediate1-2, or High Risk Trisomy 8 Myelodysplastic Syndrome (MDS)

Leukemia Clinical Trial

Official title: A Phase 2, Single-Arm Study To Assess The Efficacy and Safety Of 72-Hour Continuous Intravenous Dosing Of ON 01910.Na Administered Once Every 2 Weeks in Myelodysplastic Syndrome Patients With Trisomy 8 or Classified as Intermediate-1, 2 or High Risk

Status Completed

Clinical Trial Summary

This is a phase 2 single arm study in which fourteen MDS patients with Trisomy 8 or classified as Intermediate-1, 2, or High risk who meet all other inclusion/exclusion criteria will receive ON 01910.Na 1800 mg/24h as an intravenous continuous infusion (IVCI) over 72 hours every other week for the first four 2-week cycles and every 4 weeks afterwards.

Clinical Trial Description

Primary Objective The primary objective of this study is to evaluate the efficacy and safety of ON 01910.Na CIV 1800 mg/24h for 72-hour infusion administered every other week for 8 weeks and every 4 weeks afterwards in achieving by week 29 a complete or partial response or hematological improvement as defined per the 2006 International Working Group (IWG) Criteria in Myelodysplastic Syndrome (MDS) patients with Trisomy 8 or classified as Intermediate-1, 2, or High risk.

Secondary Objectives

The secondary objectives are to assess:

• Time and duration of bone marrow response

• Complete or partial response according to International Working Group (IWG) 2006 criteria

• Improvement of dyspoiesis as evaluated by the change in aneuploidy in bone marrow

• Change in International Prognostic Scoring System (IPSS)

• Responses in absolute neutrophil count, according to IWG 2006 criteria

• Responses in platelet count, according to IWG 2006 criteria

• Erythroid responses, according to IWG 2006 criteria

• Time to progression

• Overall survival at 29 and 53 weeks

• Proportion of patients transitioning to acute myeloid leukemia (AML) at 29 and 53 weeks

• Exploratory biomarkers on bone marrow aspirates (described in a separate companion protocol) ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Myelodysplastic Syndromes (MDS)
• Preleukemia
• Syndrome

• NCT number: NCT01326377
• Study type: Interventional
• Source: Stanford University
• Status: Completed
• Phase: Phase 2
• Start date: May 2009
• Completion date: February 2011