Stem Cell Transplant With Specially Treated Cells in Treating Patients With Acute Leukemia

AML Clinical Trial

Official title: Pilot Study of Ex Vivo Expansion of Mafosfamide-Purged CD34-Positive Cells for Autologous Peripheral Blood Stem Cell or Bone Marrow Transplantation in Patients With Acute Leukemia

Status Completed

Clinical Trial Summary

An autologous peripheral stem cell or bone marrow transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Using stem cells or bone marrow cells that are treated in the laboratory may be an effective treatment for acute leukemia.

This clinical trial is studying how well an autologous stem cell transplant using specially treated cells works in treating patients with acute leukemia.

Clinical Trial Description

Patients will receive infusions of cyclophosphamide and an infusion or injection of G-CSF once a day for 7-14 days followed by collection of their peripheral stem cells. Some patients may also undergo bone marrow collection. Patients' stem cells and/or bone marrow will be treated in the laboratory. Patients will then receive busulfan for 4 days followed by cyclophosphamide for 4 days. Two days later, patients will undergo autologous peripheral stem cell or bone marrow transplant and then receive an infusion or injection of G-CSF once a day until blood counts return to normal.

The goal of this pilot clinical study is to shorten the duration of aplasia associated with mafosfamide purged autologous transplants for acute leukemia using the cytokine cocktail of recombinant human stem cell factor (rhSCF), recombinant human granulocyte colony stimulating factor (rhG-CSF) and recombinant human thrombopoeitin (rhTPO) for ex vivo expansion.

After finishing treatment, patients will be evaluated periodically for at least 5 years. ;

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

• ALL (High Risk)
• AML

• NCT number: NCT00246649
• Study type: Interventional
• Source: Sidney Kimmel Comprehensive Cancer Center
• Status: Completed
• Phase: N/A
• Start date: September 2005