Clinical trial NCT00233961: G-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission
Official title: Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia
Keywords: chronic phase chronic myelogenous leukemia
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Feasibility and safety of harvesting chronic myeloid leukemia (CML) patients in continuous complete remission (CCR) by adequate CD34+ stem cell numbers post-harvest
Secondary outcomes:
measure: Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest
Other outcomes:
Locations:
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
state: New York
Study officials:
affiliation: Herbert Irving Comprehensive Cancer Center
name: Gwen L. Nichols, MD
role: STUDY_CHAIR
References: