Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002838
Status:
COMPLETED
Last Update Posted:
2012-07-31
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Pilot Study of Allogeneic Peripheral Blood Stem Cell Infusion For Patients With High Risk Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2012-07
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 Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with refractory chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES I Determine the feasibility and toxicity of using allogeneic peripheral blood stem cell transplantation after intensive but non-myeloablative chemotherapy with fludarabinecyclophosphamide in patients with advanced chronic lymphocytic leukemia II Determine the engraftment kinetics and degree of chimerism available with this strategy
OUTLINE This is a nonrandomized dose-seeking study Stem cell donors receive G-CSF for 4 days prior to and throughout stem cell harvest Patients receive intensive chemotherapy with fludarabine and cyclophosphamide for 3 days with patients entered at increasing doses of both drugs until the dose allowing engraftment is determined Three days after intensive chemotherapy allogeneic stem cells are infused Responding patients who do not experience worse than grade 1 acute graft-vs-host disease receive additional stem cell infusions after 60 and 120 days Patients are followed monthly for 4 months at 6 and 12 months then yearly for 5 years
PROJECTED ACCRUAL Up to 25 patients will be entered
OUTLINE This is a nonrandomized dose-seeking study Stem cell donors receive G-CSF for 4 days prior to and throughout stem cell harvest Patients receive intensive chemotherapy with fludarabine and cyclophosphamide for 3 days with patients entered at increasing doses of both drugs until the dose allowing engraftment is determined Three days after intensive chemotherapy allogeneic stem cells are infused Responding patients who do not experience worse than grade 1 acute graft-vs-host disease receive additional stem cell infusions after 60 and 120 days Patients are followed monthly for 4 months at 6 and 12 months then yearly for 5 years
PROJECTED ACCRUAL Up to 25 patients will be entered
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 |
|---|---|---|---|
| CDR0000065053 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-DM-95194 | OTHER | None | None |
| NCI-V96-1018 | None | None | None |