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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246649
• Other study ID #: J0563
• Status: Completed
• Phase: N/A
• First received: October 27, 2005
• Last updated: December 16, 2008
• Start date: September 2005

Study information

• Verified date: December 2008
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 70 Years

Eligibility

Inclusion Criteria:

• AML in high risk CR1 without a matched family donor

• AML in CR2 without an HLA-identical sibling donor

• High Risk ALL with an HLA-identical sibling donor

Exclusion Criteria:

• Available suitable matched HLA-identical sibling donor

• Intermediate or good-risk leukemia

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

Intervention

Procedure:
• Ex vivo expansion of mafosfamide purged marrow or mobilized stem cells with growth factors (rhSCF and rhTPO)

Locations

Country	Name	City	State
United States	SKCCC at Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility of ex vivo expanding a CD34 selected, mafosfamide purged autograft.
Primary	To assess the duration of aplasia associated with mafosfamide purging and ex vivo cytokine expanded autografting for high risk acute leukemia.
Primary	To estimate the event-free survival following mafosfamide purging and ex vivo cytokine expanded autografting for high risk acute leukemia
Secondary	To obtain blood samples for future laboratory studies that may include immune reconstitution.