Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002831
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Study of High-Dose Deoxyazacytidine Busulfan and Cyclophosphamide With Allogeneic Stem Cell Transplantation for Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2018-10
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 drugs and kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia
PURPOSE Phase III trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of decitabine in combination with busulfan and cyclophosphamide in patients with hematologic malignancies II Establish the pharmacokinetics of decitabine and busulfan in this patient population III Determine the effectiveness of this combination in achieving durable complete remission in patients with chronic myelogenous leukemia CML in blast crisis or acute myelogenous leukemia AML in relapse undergoing allogeneic stem cell transplantation
OUTLINE In cohorts of 3 patients receive escalating doses of decitabine DAC IV over 4 hours on days -8 and -7 Busulfan is administered orally every 6 hours on consecutive days -6 through -4 Cyclophosphamide is given by vein IV over 1 hour on consecutive days -3 and -2 The maximum tolerated dose of DAC is defined as the dose at which 2 patients experience dose limiting toxicity Donors receive filgrastim subcutaneously SQ daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion Leukapheresis is conducted daily If insufficient number of cells are collected blood marrow is harvested for supplementation Stem cells are infused on day 0 For graft vs host disease prophylaxis GVHD patients receive tacrolimus IV beginning one day before stem cell infusion then orally following tolerance to tacrolimus Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2 then orally following tolerance and engraftment All patients receive methylprednisolone given according to clinical grade of GVHD procedures For CNS prophylaxis methotrexate is given intrathecally or intraventricularly monthly beginning on the second month through the eighth month of treatment Allogeneic patients are followed until the end of 1 year
PROJECTED ACCRUAL An estimated 30 allogeneic recipients will be recruited in 2 years for the expected study duration of 2-3 years
OUTLINE In cohorts of 3 patients receive escalating doses of decitabine DAC IV over 4 hours on days -8 and -7 Busulfan is administered orally every 6 hours on consecutive days -6 through -4 Cyclophosphamide is given by vein IV over 1 hour on consecutive days -3 and -2 The maximum tolerated dose of DAC is defined as the dose at which 2 patients experience dose limiting toxicity Donors receive filgrastim subcutaneously SQ daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion Leukapheresis is conducted daily If insufficient number of cells are collected blood marrow is harvested for supplementation Stem cells are infused on day 0 For graft vs host disease prophylaxis GVHD patients receive tacrolimus IV beginning one day before stem cell infusion then orally following tolerance to tacrolimus Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2 then orally following tolerance and engraftment All patients receive methylprednisolone given according to clinical grade of GVHD procedures For CNS prophylaxis methotrexate is given intrathecally or intraventricularly monthly beginning on the second month through the eighth month of treatment Allogeneic patients are followed until the end of 1 year
PROJECTED ACCRUAL An estimated 30 allogeneic recipients will be recruited in 2 years for the expected study duration of 2-3 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 |
|---|---|---|---|
| CDR0000065033 | REGISTRY | NCIs PDQ Database | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-DM-94064 | OTHER | None | None |
| NCI-G96-0999 | None | None | None |