Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022126
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2001-08-10
Brief Title:
Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2014-02
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 Giving the drugs in different combinations may kill more cancer cells Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and kill more cancer cells
PURPOSE Phase II trial to compare the effectiveness of combination chemotherapy with or without donor bone marrow transplantation in treating infants who have previously untreated acute lymphoblastic leukemia
PURPOSE Phase II trial to compare the effectiveness of combination chemotherapy with or without donor bone marrow transplantation in treating infants who have previously untreated acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Determine the feasibility of dexamethasone-based induction chemotherapy followed by augmented Berlin-Frankfurt-Munster BFM consolidation chemotherapy with or without allogeneic bone marrow transplantation in infants with previously untreated acute lymphoblastic leukemia
Determine the event-free survival of patients treated with this regimen
Determine the clinical prognostic features associated with outcome in these patients
Compare the biologic characteristics of the leukemia cells with outcome in these patients
OUTLINE This is a multicenter study
Patients receive induction therapy comprising oral dexamethasone 3 times daily on days 1-14 daunorubicin IV on days 1 8 and 15 vincristine IV on days 1 8 15 and 22 and asparaginase intramuscularly IM on days 4 6 8 11 13 15 18 20 and 22 Patients also receive methotrexate intrathecally IT on days 1 8 and 15 and days 4 and 22 for overt CNS disease
Patients with M1 or M2 marrow after induction therapy receive augmented consolidation therapy when blood counts recover Patients receive cyclophosphamide IV on days 1 and 29 cytarabine IV or subcutaneously SC on days 2-5 9-12 30-33 and 37-40 oral mercaptopurine on days 1-14 and 29-42 vincristine IV on days 15 22 43 and 50 pegaspargase IM on days 15 and 43 and methotrexate IT on days 1 8 and 15
Patients who do not receive bone marrow transplantation BMT proceed to interim maintenance 1 when blood counts recover Patients receive methotrexate IT on days 1 11 22 and 32 methotrexate IV and vincristine IV on days 1 11 22 32 and 43 and pegaspargase IM on days 2 and 23
When blood counts recover patients receive delayed intensification 1 comprising vincristine IV on days 1 8 15 43 and 50 doxorubicin IV on days 1 8 and 15 oral dexamethasone 3 times daily on days 1-7 and 15-21 pegaspargase IM on days 4 and 43 cyclophosphamide IV on day 29 methotrexate IT on days 29 and 36 oral thioguanine on days 29-42 and cytarabine IV or SC on days 30-33 and 37-40
When blood counts recover patients receive interim maintenance 2 comprising vincristine as in interim maintenance 1 methotrexate IT on day 1 and IV on days 1 11 22 32 and 41 and pegaspargase IM on days 2 and 23
When blood counts recover patients receive delayed intensification 2 comprising vincristine doxorubicin dexamethasone pegaspargase cyclophosphamide cytarabine and thioguanine as in intensification 1 Patients also receive methotrexate IT on days 1 and 29
When blood counts recover patients receive maintenance therapy comprising methotrexate IT on day 1 and orally on days 1 8 15 22 29 36 43 50 57 64 71 and 78 vincristine IV on days 1 29 and 57 oral dexamethasone 3 times daily on days 1-5 29-33 and 57-61 and oral mercaptopurine daily Treatment repeats every 84 days for 6 courses
Patients with an allergy to pegaspargase replace it with asparaginase IM on the days after receiving methotrexate IV during interim maintenance 1 and 2 and daily over 6 days in place of each dose of pegaspargase during delayed intensification 1 and 2
After augmented consolidation therapy patients meeting the following criteria may receive BMT in place of chemotherapy
In remission
Exhibiting chromosome translocation involving 11q23 or Ph922
Available HLA-A B DR genotypic identical relative donor
No uncontrolled infection
Adequate organ function Within 3-4 weeks of consolidation therapy patients undergoing allogeneic BMT receive cytarabine IV over 1 hour on days -8 to -5 cyclophosphamide IV over 30 minutes on days -7 and -6 and methylprednisolone IV twice daily on days -2 to 0 Patients also undergo total body irradiation twice daily on days -3 to 0 Patients receive allogeneic BMT on day 0 Patients also receive cyclosporine IV every 12 hours beginning on day -1 switching to oral when possible and continuing until day 60 Patients then taper cyclosporine over the next 60-120 days
Patients are followed every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year every 6 months for 1-2 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 20-40 patients will be accrued for this study within 2 years
Determine the feasibility of dexamethasone-based induction chemotherapy followed by augmented Berlin-Frankfurt-Munster BFM consolidation chemotherapy with or without allogeneic bone marrow transplantation in infants with previously untreated acute lymphoblastic leukemia
Determine the event-free survival of patients treated with this regimen
Determine the clinical prognostic features associated with outcome in these patients
Compare the biologic characteristics of the leukemia cells with outcome in these patients
OUTLINE This is a multicenter study
Patients receive induction therapy comprising oral dexamethasone 3 times daily on days 1-14 daunorubicin IV on days 1 8 and 15 vincristine IV on days 1 8 15 and 22 and asparaginase intramuscularly IM on days 4 6 8 11 13 15 18 20 and 22 Patients also receive methotrexate intrathecally IT on days 1 8 and 15 and days 4 and 22 for overt CNS disease
Patients with M1 or M2 marrow after induction therapy receive augmented consolidation therapy when blood counts recover Patients receive cyclophosphamide IV on days 1 and 29 cytarabine IV or subcutaneously SC on days 2-5 9-12 30-33 and 37-40 oral mercaptopurine on days 1-14 and 29-42 vincristine IV on days 15 22 43 and 50 pegaspargase IM on days 15 and 43 and methotrexate IT on days 1 8 and 15
Patients who do not receive bone marrow transplantation BMT proceed to interim maintenance 1 when blood counts recover Patients receive methotrexate IT on days 1 11 22 and 32 methotrexate IV and vincristine IV on days 1 11 22 32 and 43 and pegaspargase IM on days 2 and 23
When blood counts recover patients receive delayed intensification 1 comprising vincristine IV on days 1 8 15 43 and 50 doxorubicin IV on days 1 8 and 15 oral dexamethasone 3 times daily on days 1-7 and 15-21 pegaspargase IM on days 4 and 43 cyclophosphamide IV on day 29 methotrexate IT on days 29 and 36 oral thioguanine on days 29-42 and cytarabine IV or SC on days 30-33 and 37-40
When blood counts recover patients receive interim maintenance 2 comprising vincristine as in interim maintenance 1 methotrexate IT on day 1 and IV on days 1 11 22 32 and 41 and pegaspargase IM on days 2 and 23
When blood counts recover patients receive delayed intensification 2 comprising vincristine doxorubicin dexamethasone pegaspargase cyclophosphamide cytarabine and thioguanine as in intensification 1 Patients also receive methotrexate IT on days 1 and 29
When blood counts recover patients receive maintenance therapy comprising methotrexate IT on day 1 and orally on days 1 8 15 22 29 36 43 50 57 64 71 and 78 vincristine IV on days 1 29 and 57 oral dexamethasone 3 times daily on days 1-5 29-33 and 57-61 and oral mercaptopurine daily Treatment repeats every 84 days for 6 courses
Patients with an allergy to pegaspargase replace it with asparaginase IM on the days after receiving methotrexate IV during interim maintenance 1 and 2 and daily over 6 days in place of each dose of pegaspargase during delayed intensification 1 and 2
After augmented consolidation therapy patients meeting the following criteria may receive BMT in place of chemotherapy
In remission
Exhibiting chromosome translocation involving 11q23 or Ph922
Available HLA-A B DR genotypic identical relative donor
No uncontrolled infection
Adequate organ function Within 3-4 weeks of consolidation therapy patients undergoing allogeneic BMT receive cytarabine IV over 1 hour on days -8 to -5 cyclophosphamide IV over 30 minutes on days -7 and -6 and methylprednisolone IV twice daily on days -2 to 0 Patients also undergo total body irradiation twice daily on days -3 to 0 Patients receive allogeneic BMT on day 0 Patients also receive cyclosporine IV every 12 hours beginning on day -1 switching to oral when possible and continuing until day 60 Patients then taper cyclosporine over the next 60-120 days
Patients are followed every 2 months for 1 year every 3 months for 1 year every 4 months for 1 year every 6 months for 1-2 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 20-40 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| COG-AALL01P1 | OTHER | None | None |
| CDR0000068787 | OTHER | ClinicalTrialsgov | None |