Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004905
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2000-03-07
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia or Acute Leukemia
Sponsor:
Loyola University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Study of Intensive Chemotherapy Followed by Peripheral Blood Stem Cell Harvesting for Autotransplantation of Adults With Chronic Myelogenous Leukemia and High Risk Acute Leukemia
Status:
COMPLETED
Status Verified Date:
2001-02
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 Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Clinical trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia or acute leukemia
PURPOSE Clinical trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have chronic myelogenous leukemia or acute leukemia
Detailed Description:
OBJECTIVES I Determine safety and toxicity of induction and transplant regimens in patients with chronic myelogenous leukemia or high-risk acute leukemia II Determine efficacy of collecting peripheral blood stem cells PBSC during early hematopoietic recovery from intensive chemotherapy as a means for in vivo enrichment for cytogenetically normal progenitor cells in this patient population III Correlate cytogenetic and molecular responses in the peripheral blood and bone marrow with clinical response time to progression and survival in these patients at several timepoints before and after myelosuppressive and myeloablative therapy
OUTLINE This is a multicenter study Patients are stratified according to disease chronic myelogenous leukemia vs acute lymphoblastic leukemia vs acute myelogenous leukemia Patients receive cytarabine IV over 4 hours etoposide IV over 15-2 hours and idarubicin IV over 5-10 minutes on days 1 3 and 5 Filgrastim G-CSF is administered subcutaneously SC daily beginning on day 2 and continuing until blood counts recover Chronic myelogenous leukemia On day 14 following chemotherapy if bone marrow biopsy shows less than 20 cellularity and a peripheral blood sample contains greater than 50 cytogenetically normal cells patients receive a second induction course followed by apheresis Patients with less than 50 cytogenetically normal cells are also considered for a second induction course Patients with no response or progressive disease are removed from the study Acute leukemia On day 14 following chemotherapy if bone marrow biopsy shows less than 20 cellularity and the peripheral blood sample shows 100 cytogenetically normal cells patients receive a second induction course followed by apheresis Patients with high risk disease in first remission at time of study entry undergo apheresis during recovery from first course of induction therapy and second course may be omitted Patients receive second induction course followed by G-CSF as after first induction course Once blood counts recover patients undergo harvest of peripheral blood stem cells PBSC Patients also undergo bone marrow stem cell collection in case of failure of PBSC transplantation PBSCT Patients receive the following conditioning regimen total body irradiation twice a day on days -8 to -5 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2 PBSCT is conducted on day 0 G-CSF SC is administered beginning on day 1 and continues until blood counts recover Patients receive maintenance therapy with interferon alfa SC 3 times a week for 12 months Patients are followed weekly for 3 months and then monthly until death
PROJECTED ACCRUAL Approximately 15 patients will be accrued for this study
OUTLINE This is a multicenter study Patients are stratified according to disease chronic myelogenous leukemia vs acute lymphoblastic leukemia vs acute myelogenous leukemia Patients receive cytarabine IV over 4 hours etoposide IV over 15-2 hours and idarubicin IV over 5-10 minutes on days 1 3 and 5 Filgrastim G-CSF is administered subcutaneously SC daily beginning on day 2 and continuing until blood counts recover Chronic myelogenous leukemia On day 14 following chemotherapy if bone marrow biopsy shows less than 20 cellularity and a peripheral blood sample contains greater than 50 cytogenetically normal cells patients receive a second induction course followed by apheresis Patients with less than 50 cytogenetically normal cells are also considered for a second induction course Patients with no response or progressive disease are removed from the study Acute leukemia On day 14 following chemotherapy if bone marrow biopsy shows less than 20 cellularity and the peripheral blood sample shows 100 cytogenetically normal cells patients receive a second induction course followed by apheresis Patients with high risk disease in first remission at time of study entry undergo apheresis during recovery from first course of induction therapy and second course may be omitted Patients receive second induction course followed by G-CSF as after first induction course Once blood counts recover patients undergo harvest of peripheral blood stem cells PBSC Patients also undergo bone marrow stem cell collection in case of failure of PBSC transplantation PBSCT Patients receive the following conditioning regimen total body irradiation twice a day on days -8 to -5 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2 PBSCT is conducted on day 0 G-CSF SC is administered beginning on day 1 and continues until blood counts recover Patients receive maintenance therapy with interferon alfa SC 3 times a week for 12 months Patients are followed weekly for 3 months and then monthly until death
PROJECTED ACCRUAL Approximately 15 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G00-1702 | Registry Identifier | PDQ Physician Data Query | None |
| NU-L94H2 | None | None | None |
| CDR0000067584 | REGISTRY | None | None |