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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00246649
Other study ID # J0563
Secondary ID
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
Est. completion date
Est. primary completion date
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


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.
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