NCT01677949

Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

A Phase II Trial Investigating Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Study Design: This is a two-stage Phase II trial investigating the efficacy of Clofarabine, Cyclophosphamide and Etoposide in acute leukemia patients with detectable minimal residual disease (MRD) prior to allo-HCT. The primary objective is to determine the impact of the study treatment in eliminating the presence of minimal residual disease without causing a significant delay of allo-HCT due to treatment related toxicity. The intent of this study is to allow patients to proceed to transplant (independent of this study) within 42 days of Day 1 of Clofarabine based therapy.

Detailed description

Patients will be stratified at the time of enrollment based on diagnosis (ALL versus AML). Based on this two-stage optimal design, a maximum of 49 patients with ALL and a maximum of 49 patients with AML will be needed. For each disease cohort, 21 patients will be enrolled in stage 1. If at the end of stage 1, the criteria is met for activating stage 2 (based on success of clearing MRD, proceeding to transplant within 42 days and without excessive toxicity) for one or both groups, stage 2 will be activated with an additional 28 patients enrolled.

Conditions

• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Clofarabine	Days 1-5: Clofarabine 30 mg/m\^2 for 0-30 years of age or 20 mg/m\^2 for \> 30 years of age intravenously (IV) over 2 hours
DRUG	Etoposide	Days 1-5: Etoposide 100mg/m\^2 IV over 2 hours
DRUG	Cyclophosphamide	Days 1-5: Cyclophosphamide 300 mg/m\^2 as a 30-60 minute infusion
BIOLOGICAL	allogeneic hematopoietic cell transplantation	Between Days 28 and 42: infused independent of this study

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2012-09-03
• Last updated: 2017-12-02

Locations

1 site across 1 country: United States