Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2005-08-25
Brief Title:
A Study in Adults With Untreated Acute Lymphoblastic Leukemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Multicenter Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia ALL between the ages of 18 and 50 years
Detailed Description:
This study has four treatment phases 1 induction 2 central nervous system therapy 3 intensification and 4 continuation
The induction phase lasts one month and eight drugs are used during this phase of treatment The drugs are administered as follows
Prednisone on days 1-28
Vincristine on days 1 8 15 and 22
Doxorubicin on days 1 and 2
Methotrexate on day 3
Leucovorin 36 hours after methotrexate
Asparaginase on day 5
Intra-thecal Cytarabine on days 1 15 and 29
Intra-thecal MethotrexateHydrocortisone on days 15 and 29
A bone marrow aspirate and biopsy will be obtained on day 15 and day 29 of induction therapy If on day 29 the patients bone marrow and peripheral blood counts are not in complete remission then the patient may receive vincristine on days 29 36 and 43 Bone marrow biopsy will be repeated weekly until complete remission is documented If the patient does not achieve complete remission by day 49 they will be removed from the study
Central nervous system CNS therapy begins immediately after the end of the induction therapy This phase of treatment should last 3 weeks Treatment includes a series of spinal taps with the instillation of anti-leukemia drugs Four spinal taps will be performed over a two week period Anti-leukemia drugs will also be given orally The drugs given are as follows Vincristine on day 1 Doxorubicin on day 1 6-mercaptopurine 6-MP on days 1-14 Intra-thecal MethotrexateCytarabine 4 times over 2 weeks
Radiation therapy RT will be delivered in 10 daily treatments during the CNS phase of therapy
The intensification phase begins as soon as the CNS phase ends and lasts approximately 30 weeks It consists of cycles of chemotherapy repeated every 3 weeks along with asparaginase administered weekly The drugs given are as follows Vincristine day 1 Dexamethasone days 1-5 6-MP days 1-14 Doxorubicin day 1 Asparaginase weekly Methotrexate weekly Intra-thecal HydrocortisoneMethotrexatecytarabine every 18 weeks
The continuation phase of treatment begins after the intensification phase It consists of cycles of chemotherapy repeated every three weeks and will last until the patient is in remission for two years The drugs given are Vincristine day 1 Prednisone or Dexamethasone days 1-5 6-MP days 1-14 Methotrexate weekly Intra-thecal MethotrexateCytarabineHydrocortisone every 18 weeks
During this study blood tests will be performed at the start of therapy at day 29 post induction and at the time of each intra-thecal therapy every 18 weeks
Bone marrow biopsyaspirate will be done days 15 and 29 of induction then every 6 months until completion
The induction phase lasts one month and eight drugs are used during this phase of treatment The drugs are administered as follows
Prednisone on days 1-28
Vincristine on days 1 8 15 and 22
Doxorubicin on days 1 and 2
Methotrexate on day 3
Leucovorin 36 hours after methotrexate
Asparaginase on day 5
Intra-thecal Cytarabine on days 1 15 and 29
Intra-thecal MethotrexateHydrocortisone on days 15 and 29
A bone marrow aspirate and biopsy will be obtained on day 15 and day 29 of induction therapy If on day 29 the patients bone marrow and peripheral blood counts are not in complete remission then the patient may receive vincristine on days 29 36 and 43 Bone marrow biopsy will be repeated weekly until complete remission is documented If the patient does not achieve complete remission by day 49 they will be removed from the study
Central nervous system CNS therapy begins immediately after the end of the induction therapy This phase of treatment should last 3 weeks Treatment includes a series of spinal taps with the instillation of anti-leukemia drugs Four spinal taps will be performed over a two week period Anti-leukemia drugs will also be given orally The drugs given are as follows Vincristine on day 1 Doxorubicin on day 1 6-mercaptopurine 6-MP on days 1-14 Intra-thecal MethotrexateCytarabine 4 times over 2 weeks
Radiation therapy RT will be delivered in 10 daily treatments during the CNS phase of therapy
The intensification phase begins as soon as the CNS phase ends and lasts approximately 30 weeks It consists of cycles of chemotherapy repeated every 3 weeks along with asparaginase administered weekly The drugs given are as follows Vincristine day 1 Dexamethasone days 1-5 6-MP days 1-14 Doxorubicin day 1 Asparaginase weekly Methotrexate weekly Intra-thecal HydrocortisoneMethotrexatecytarabine every 18 weeks
The continuation phase of treatment begins after the intensification phase It consists of cycles of chemotherapy repeated every three weeks and will last until the patient is in remission for two years The drugs given are Vincristine day 1 Prednisone or Dexamethasone days 1-5 6-MP days 1-14 Methotrexate weekly Intra-thecal MethotrexateCytarabineHydrocortisone every 18 weeks
During this study blood tests will be performed at the start of therapy at day 29 post induction and at the time of each intra-thecal therapy every 18 weeks
Bone marrow biopsyaspirate will be done days 15 and 29 of induction then every 6 months until completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None