Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002592
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
1999-11-01
Brief Title:
Chemotherapy and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
AUTOLOGOUS BONE MARROW TRANSPLANTATION USING C-MYB LR-3001 ANTISENSE OLIGODEOXYNUCLEOTIDE TREATED BONE MARROW IN CHRONIC MYELOGENOUS LEUKEMIA IN CHRONIC OR ACCELERATED PHASE
Status:
COMPLETED
Status Verified Date:
2015-01
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 tumor cells from dividing so they stop growing or die Combining chemotherapy with autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by autologous bone marrow transplantation in treating patients with chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by autologous bone marrow transplantation in treating patients with chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Evaluate the ability of c-myb antisense oligodeoxynucleotide to purge bone marrow cells of clonogenic chronic myelogenous leukemia tumor cells and repopulate the bone marrow with normal stem cells in patients treated with high-dose busulfan and cyclophosphamide followed by autologous bone marrow transplantation using marrow treated with c-myb antisense oligodeoxynucleotide II Determine the response rate degree of hematopoietic reconstitution overall survival and relapse-free survival of patients treated with this regimen III Determine the toxicity of this regimen in these patients
OUTLINE Patients undergo bone marrow harvest The bone marrow is treated with c-myb antisense oligodeoxynucleotide and cryopreserved A portion of the marrow is cryopreserved untreated in case of engraftment failure Patients receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses Patients receive cyclophosphamide IV over 1 hour on days -3 and -2 Bone marrow is reinfused on day 0 Patients receive filgrastim G-CSF subcutaneously daily beginning on day 0 and continuing until blood counts recover Patients are followed every 2-3 months for 2 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 18-24 months
OUTLINE Patients undergo bone marrow harvest The bone marrow is treated with c-myb antisense oligodeoxynucleotide and cryopreserved A portion of the marrow is cryopreserved untreated in case of engraftment failure Patients receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses Patients receive cyclophosphamide IV over 1 hour on days -3 and -2 Bone marrow is reinfused on day 0 Patients receive filgrastim G-CSF subcutaneously daily beginning on day 0 and continuing until blood counts recover Patients are followed every 2-3 months for 2 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 18-24 months
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-H94-0532 | None | None | None |
| UPCC-3492 | None | None | None |