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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00246649
First received: October 27, 2005
Last updated: December 16, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention
AML
ALL (High Risk)
Procedure: Ex vivo expansion of mafosfamide purged marrow or mobilized stem cells with growth factors (rhSCF and rhTPO)

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

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • To assess the feasibility of ex vivo expanding a CD34 selected, mafosfamide purged autograft.
  • To assess the duration of aplasia associated with mafosfamide purging and ex vivo cytokine expanded autografting for high risk acute leukemia.
  • To estimate the event-free survival following mafosfamide purging and ex vivo cytokine expanded autografting for high risk acute leukemia

Secondary Outcome Measures:
  • To obtain blood samples for future laboratory studies that may include immune reconstitution.

Estimated Enrollment: 25
Study Start Date: September 2005
Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Year to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246649

Locations
United States, Maryland
SKCCC at Johns Hopkins Hospital
Baltimore, Maryland, United States, 21234
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: B. Douglas Smith, M.D. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00246649     History of Changes
Other Study ID Numbers: J0563
Study First Received: October 27, 2005
Last Updated: December 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Mafosfamide
Growth Factor
Stem Cell
Bone Marrow

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Mitogens
Mafosfamide
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014