NCT01701323

Expanded Cord Blood Cell Infusion Following Combination Chemotherapy in Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Chemotherapy (FLAG) in Patients With AML or Acute Leukemia of Ambiguous Lineage

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Nohla Therapeutics, Inc. · Industry
• Sex: All
• Age: 6 Months – 30 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies infusion of expanded cord blood hematopoietic progenitor cells following combination chemotherapy in treating younger patients with acute myeloid leukemia that has relapsed or has not responded to treatment. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemotherapy also kills healthy infection-fighting cells, increasing the risk of infection. The infusion of expanded cord blood hematopoietic progenitor cells may be able to replace blood-forming cells that were destroyed by chemotherapy. This cellular therapy may decrease the risk of infection following chemotherapy.

Conditions

• Acute Leukemia of Ambiguous Lineage
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion	Given IV
DRUG	Cytarabine	Given IV
DRUG	Filgrastim	Given SC or IV
DRUG	Fludarabine Phosphate	Given IV

Timeline

• Start date: 2012-12-10
• Primary completion: 2018-05-10
• Completion: 2018-05-10
• First posted: 2012-10-05
• Last updated: 2019-03-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study