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Ex Vivo Expansion of Mafosfamide Purged CD34+ Cells in Patients With Acute Leukemia


N/A
N/A
70 Years
Open (Enrolling)
Both
Leukemia

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Trial Information

Ex Vivo Expansion of Mafosfamide Purged CD34+ Cells in Patients With Acute Leukemia


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

B. Douglas Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000453619

NCT ID:

NCT00245115

Start Date:

October 2005

Completion Date:

Related Keywords:

  • Leukemia
  • 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
  • Leukemia

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410