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Autologous Peripheral Stem Cell or Bone Marrow Transplant Using Laboratory-Treated Cells in Treating Patients With Acute Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00245115
First received: October 25, 2005
Last updated: July 19, 2011
Last verified: April 2011
History of Changes
  Purpose

RATIONALE: Giving colony-stimulating factors, such as G-CSF, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected. Treating stem cells collected from the patient's blood or bone marrow with chemotherapy in the laboratory removes any remaining cancer cells. Chemotherapy or radiation therapy is given to the patient to prepare the bone marrow for stem cell transplant. The treated stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This clinical trial is studying how well an autologous peripheral stem cell or bone marrow transplant using laboratory-treated cells works in treating patients with acute leukemia.


Condition Intervention
Leukemia
 Biological: filgrastim
Drug: busulfan
Drug: cyclophosphamide
Procedure: in vitro-treated bone marrow transplantation
Procedure: in vitro-treated peripheral blood stem cell transplantation

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Ex Vivo Expansion of Mafosfamide Purged CD34+ Cells in Patients With Acute Leukemia

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 25
Study Start Date: October 2005
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the feasibility of ex vivo expanded mafosfamide-purged CD34-positive cells for autologous peripheral blood stem cell or bone marrow transplantation in patients with acute leukemia.
  • Determine the duration of aplasia associated with the use of ex vivo cytokine expanded mafosfamide-purged cells in patients treated with this regimen.
  • Determine, preliminarily, the event-free survival of patients treated with this regimen.

OUTLINE: This is a pilot study.

  • Mobilization and stem cell collection: Patients receive cyclophosphamide IV and filgrastim (G-CSF) subcutaneously (SC) or IV once daily for 7-14 days followed by leukapheresis to collect peripheral blood stem cells (PBSCs). Some patients may also undergo bone marrow (BM) harvest if sufficient PBSCs are not collected. Patients with a sufficient number of stem cells or BM (5 x 10^6 PBSC/kg or 3 x 10^8 BM cells/kg) proceed to autologous PBSC transplantation (PBSCT) or BM transplantation (BMT).
  • CD34-positive cell selection and mafosfamide purging: Collected PBSCs and/or BM are treated in the laboratory to isolate CD34-positive cells. A minimum of 1 x 10^6 nucleated CD34-positive BM cells/kg or 2 x 10^6 nucleated CD34-positive PBSCs/kg must be available after selection to proceed to mafosfamide-purging. The selected cells are then treated in vitro with mafosfamide to purge remaining leukemic cells. One third of the mafosfamide-purged cells are then cryopreserved for future use and 2/3 of the mafosfamide-purged cells proceed to ex vivo expansion.
  • Ex vivo expansion: The remaining CD34-positive mafosfamide-purged cells are treated in vitro with stem cell factor, G-CSF, and recombinant human thrombopoietin and incubated for 12-14 days.
  • Myeloablative therapy: Patients receive busulfan on days -9 to -6 and cyclophosphamide on days -5 to -2.
  • PBSCT or BMT: Patients undergo autologous PBSCT or BMT using CD34-positive mafosfamide-purged cryopreserved cells and ex vivo expanded CD34-positive mafosfamide-purged cells on day 0 followed by G-CSF SC or IV once daily until blood counts recover.

After completion of study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of acute leukemia meeting 1 of the following criteria:

    • High-risk acute myeloid leukemia (AML) in first complete remission (CR) with no matched family donor available, including any of the following types:

      • Secondary AML
      • AML with chromosome 5 or 7 abnormalities
      • AML with trisomy 8
      • AML with 6;9 chromosomal translocation
      • AML with 11q23 chromosomal abnormality
      • AML with multiple or complex chromosomal abnormalities
      • AML with FAB M6 or M7
    • AML in second CR (CR2) with no eligible HLA-identical sibling donor available

    • High-risk acute lymphoblastic leukemia (ALL) with no eligible HLA-identical sibling donor available, including any of the following types:

      • Philadelphia chromosome-positive ALL
      • ALL with 11q23 chromosomal abnormality
      • ALL in CR2
  • Eligible for and willing to undergo bone marrow transplantation
  • No intermediate- or good-risk acute leukemia in CR1

PATIENT CHARACTERISTICS:

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Not pregnant
  • Fertile patients must use effective contraception
  • HIV negative
  • Weight ≥ 10 kg
  • No poor organ function

PRIOR CONCURRENT THERAPY: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245115

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: B. Douglas Smith, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00245115     History of Changes
Other Study ID Numbers: CDR0000453619, P01CA070970, P30CA006973, JHOC-J0563, JHOC-NA-00000920
Study First Received: October 25, 2005
Last Updated: July 19, 2011
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
adult acute myeloblastic leukemia without maturation (M1)
childhood acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
childhood acute myeloblastic leukemia with maturation (M2)
adult acute promyelocytic leukemia (M3)
childhood acute promyelocytic leukemia (M3)
adult acute myelomonocytic leukemia (M4)
childhood acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
childhood acute monoblastic leukemia (M5a)
childhood acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
 childhood acute erythroleukemia (M6)
adult acute megakaryoblastic leukemia (M7)
childhood acute megakaryocytic leukemia (M7)
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
secondary acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Busulfan
Cyclophosphamide
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antirheumatic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 19, 2013