NCT02349178

Bridging Study to Eliminate Presence of MRD for Acute Leukemia Before HCT

Bridging Study: A Phase 2 Study Investigating Clofarabine, Cyclophosphamide and Etoposide for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia and Minimal Residual Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 39 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study designed for the purpose of estimating various parameters surrounding the efficacy of Clofarabine, Cyclophosphamide and Etoposide in eliminating minimal residual disease (MRD) in acute leukemia patients otherwise in remission and without causing significant delay of HCT due to treatment related toxicity. A single course of "bridge" chemotherapy is given prior to the transplant procedure as an approach to improved disease-free survival in a patient group who historically has had inferior outcomes.

Detailed description

Study entry is open to patients regardless of gender or ethnic background. The intent of this study design is for all patients to receive and complete one course of therapy. Patients who exhibit signs of disease progression or experience an unacceptable toxicity will be discontinued from treatment. There will be no dose delays or dose reductions of study drugs for hematologic toxicity during Consolidation "Bridging" therapy (Day 1 through Day 30); however, prolonged hematopoietic recovery or bone marrow aplasia during the first 42 days may meet a study stopping rule.

Conditions

• Leukemia, Acute Lymphoblastic
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Clofarabine	Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours
DRUG	Cyclophosphamide	Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion
DRUG	Etoposide	Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours

Timeline

• Start date: 2014-12-08
• Primary completion: 2017-03-16
• Completion: 2017-03-16
• First posted: 2015-01-28
• Last updated: 2020-03-09
• Results posted: 2019-02-12

Locations

4 sites across 1 country: United States