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Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response


OBJECTIVES:

- Determine the feasibility and safety of harvesting adequate numbers of CD34-positive
peripheral blood stem cells using filgrastim (G-CSF) in patients with chronic phase
chronic myeloid leukemia in complete cytogenetic remission.

- Determine the safety of temporarily discontinuing treatment with imatinib mesylate and
using G-CSF during the harvesting procedure, in terms of the percentage of Philadelphia
chromosome (Ph)-positive cells before and after stem cell harvest, in these patients.

OUTLINE: Patients receive filgrastim (G-CSF) and then undergo apheresis for up to 5 days.

After completion of apheresis, patients resume treatment with imatinib mesylate off study.
Patients may later undergo autologous peripheral blood stem cell transplantation, when
deemed necessary.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of chronic phase chronic myeloid leukemia

- In complete cytogenetic remission, confirmed by bone marrow biopsy within the
past month

- Has been receiving imatinib mesylate for ≥ 3 months* NOTE: *Imatinib mesylate is held
during the study harvesting procedure

- No myelofibrosis on bone marrow ≥ 3+

- Ineligible for or refused allogeneic stem cell transplantation

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- WBC > 3,000/mm^3

- Platelet count > 100,000/mm^3

Hepatic

- Adequate hepatic function for stem cell transplantation

Renal

- Adequate renal function for stem cell transplantation

Cardiovascular

- Adequate cardiovascular function for stem cell transplantation

Pulmonary

- Adequate pulmonary function for stem cell transplantation

Other

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No other concurrent biologic therapy

Chemotherapy

- More than 4 weeks since prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No concurrent radiotherapy

Surgery

- No concurrent surgery

Other

- No other concurrent experimental therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility and safety of harvesting chronic myeloid leukemia (CML) patients in continuous complete remission (CCR) by adequate CD34+ stem cell numbers post-harvest

Safety Issue:

Yes

Principal Investigator

Gwen L. Nichols, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000441128

NCT ID:

NCT00233961

Start Date:

January 2005

Completion Date:

January 2008

Related Keywords:

  • Leukemia
  • chronic phase chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032