G-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233961
• Other study ID #: CDR0000441128
• Secondary ID: CPMC-AAAA9963
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2005
• Last updated: February 1, 2013
• Start date: January 2005
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant.

PURPOSE: This phase I trial is studying the side effects of G-CSF in stimulating peripheral stem cells for autologous stem cell transplant in treating patients with chronic phase chronic myeloid leukemia in remission.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Biological:
• filgrastim

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Herbert Irving Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and safety of harvesting chronic myeloid leukemia (CML) patients in continuous complete remission (CCR) by adequate CD34+ stem cell numbers post-harvest			Yes
Secondary	Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest			No