Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002674
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
CYTOREDUCTIVE CHEMOTHERAPY WITH MITOXANTRONE CYTOSINE ARABINOSIDE AND ETOPOSIDE FOLLOWED BY RECOMBINANT HUMAN G-CSF FOR MOBILIZATION OF PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by G-CSF and peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by G-CSF and peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Evaluate the efficacy of MCE mitoxantronecytarabineetoposide followed by granulocyte colony-stimulating factor to mobilize peripheral blood stem cells PBSC in patients with chronic myeloid leukemia CML II Evaluate the toxicity of this regimen III Evaluate the cytoreductive effects of this regimen in CML as determined by the ability to mobilize Philadelphia chromosome-negative PBSC IV Assess the time of peak CD34 and CD34CD38- cell concentrations in the peripheral blood of patients treated with this regimen
OUTLINE The following acronyms are used ARA-C Cytarabine NSC-63878 DHAD Mitoxantrone NSC-301739 G-CSF Granulocyte Colony-Stimulating Factor source not specified HU Hydroxyurea NSC-32065 MCE DHADARA-CVP-16 VP-16 Etoposide NSC-141540 Single-Agent Cytoreduction followed by 3-Drug Combination ChemotherapyStem Cell Mobilization HU followed by MCE G-CSF
PROJECTED ACCRUAL 30 patients will be entered over 3 years
OUTLINE The following acronyms are used ARA-C Cytarabine NSC-63878 DHAD Mitoxantrone NSC-301739 G-CSF Granulocyte Colony-Stimulating Factor source not specified HU Hydroxyurea NSC-32065 MCE DHADARA-CVP-16 VP-16 Etoposide NSC-141540 Single-Agent Cytoreduction followed by 3-Drug Combination ChemotherapyStem Cell Mobilization HU followed by MCE G-CSF
PROJECTED ACCRUAL 30 patients will be entered over 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000064310 | REGISTRY | PDQ | None |
| FHCRC-92800 | None | None | None |
| NCI-H95-0705 | None | None | None |