NCT00233961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 4, 2013

Status Verified

January 1, 2008

Enrollment Period

2.8 years

First QC Date

October 5, 2005

Last Update Submit

February 1, 2013

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest

Interventions

filgrastimBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-Phase

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Gwen L. Nichols, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2005

First Posted

October 6, 2005

Study Start

January 1, 2005

Primary Completion

November 1, 2007

Study Completion

January 1, 2008

Last Updated

February 4, 2013

Record last verified: 2008-01

Locations

US(1)