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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


N/A
1 Year
70 Years
Not Enrolling
Both
AML, ALL (High Risk)

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the feasibility of ex vivo expanding a CD34 selected, mafosfamide purged autograft.

Principal Investigator

B. Douglas Smith, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Authority:

United States: Food and Drug Administration

Study ID:

J0563

NCT ID:

NCT00246649

Start Date:

September 2005

Completion Date:

Related Keywords:

  • AML
  • ALL (High Risk)
  • Mafosfamide
  • Growth Factor
  • Stem Cell
  • Bone Marrow
  • Leukemia

Name

Location

SKCCC at Johns Hopkins HospitalBaltimore, Maryland  21234