Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109837
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2005-05-03
Brief Title:
S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy
Status:
COMPLETED
Status Verified Date:
2015-03
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 work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy and giving the drugs in different combinations may kill more cancer cells
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the probability of 1-year continuous complete remission in patients with newly diagnosed acute lymphoblastic leukemia treated with first induction chemotherapy comprising daunorubicin vincristine prednisone and pegaspargase and second induction chemotherapy comprising high-dose cytarabine and mitoxantrone
Secondary
Determine the frequency and severity of toxic effects of these induction regimens followed by consolidation therapy comprising cyclophosphamide cytarabine mercaptopurine and methotrexate and maintenance chemotherapy comprising mercaptopurine methotrexate vincristine doxorubicin dexamethasone cyclophosphamide thioguanine and cytarabine in these patients
Other objectives if funding allows
To evaluate in a preliminary manner the significance of detecting minimal residual disease as a prognostic factor for survival and relapse-free survival of patients receiving chemotherapy
To evaluate in a preliminary manner the pattern of gene expression of patients entered onto the trial and its relationship to cytogeneticsFISH risk classification overall survival and relapse-free survival
OUTLINE This is a multicenter study
First induction chemotherapy Patients receive daunorubicin IV on days 1-3 vincristine IV on days 1 8 15 and 22 prednisone IV or orally on days 1-28 followed by a taper to day 35 and pegaspargase IV or subcutaneously SC on day 15 Patients with CNS leukemia also receive methotrexate intrathecally IT or intraventricularly twice weekly and oral leucovorin calcium four times daily for 4 doses after each administration of methotrexate When blasts are no longer present in the spinal fluid patients receive methotrexate IT or intraventricularly once weekly for 4 weeks and then once monthly for 1 year
Patients are reevaluated on day 28 Patients who achieve A1 bone marrow status and B1 peripheral blood status or those with resistant disease proceed to second induction therapy
Second induction chemotherapy Patients receive high-dose cytarabine IV on days 1-5 mitoxantrone IV on day 3 and filgrastim G-CSF SC or IV beginning on day 7 and continuing until blood counts recover Patients with CNS leukemia also receive methotrexate and leucovorin calcium as in first induction chemotherapy
Patients are reevaluated on day 28 Patients who achieve A1 bone marrow status and B1 peripheral blood status with no extramedullary disease other than CNS involvement proceed to consolidation chemotherapy Patients with resistant disease OR Philadelphia chromosome- or BCRABL-positive disease are removed from the study after receiving double induction chemotherapy
Consolidation chemotherapy Patients receive cyclophosphamide IV on days 1 15 and 29 cytarabine IV on days 2-5 and 16-19 oral mercaptopurine on days 1-28 and methotrexate IT or intraventricularly on days 2 9 16 and 23 Patients with CNS leukemia also undergo cranial radiotherapy once daily 5 days a week for 2 weeks
Patients in complete remission proceed to maintenance chemotherapy
Maintenance chemotherapy
Course 1 Patients receive oral mercaptopurine on days 1-63 and oral methotrexate on days 1 8 15 22 29 36 43 50 and 57 Patients proceed to course 2 after blood counts recover
Course 2 Patients receive vincristine IV and doxorubicin IV on days 1 8 15 and 22 and oral dexamethasone on days 1-28 Patients proceed to course 3 after blood counts recover
Course 3 Patients receive cyclophosphamide IV on day 1 oral thioguanine on days 1-14 and cytarabine IV on days 3-6 and 10-13 Patients proceed to course 4 after blood counts recover
Course 4 Patients receive oral mercaptopurine once daily for 2 years and oral methotrexate once weekly for 2 years
Treatment continues in the absence of disease relapse or unacceptable toxicity
After completion of study therapy patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
Primary
Determine the probability of 1-year continuous complete remission in patients with newly diagnosed acute lymphoblastic leukemia treated with first induction chemotherapy comprising daunorubicin vincristine prednisone and pegaspargase and second induction chemotherapy comprising high-dose cytarabine and mitoxantrone
Secondary
Determine the frequency and severity of toxic effects of these induction regimens followed by consolidation therapy comprising cyclophosphamide cytarabine mercaptopurine and methotrexate and maintenance chemotherapy comprising mercaptopurine methotrexate vincristine doxorubicin dexamethasone cyclophosphamide thioguanine and cytarabine in these patients
Other objectives if funding allows
To evaluate in a preliminary manner the significance of detecting minimal residual disease as a prognostic factor for survival and relapse-free survival of patients receiving chemotherapy
To evaluate in a preliminary manner the pattern of gene expression of patients entered onto the trial and its relationship to cytogeneticsFISH risk classification overall survival and relapse-free survival
OUTLINE This is a multicenter study
First induction chemotherapy Patients receive daunorubicin IV on days 1-3 vincristine IV on days 1 8 15 and 22 prednisone IV or orally on days 1-28 followed by a taper to day 35 and pegaspargase IV or subcutaneously SC on day 15 Patients with CNS leukemia also receive methotrexate intrathecally IT or intraventricularly twice weekly and oral leucovorin calcium four times daily for 4 doses after each administration of methotrexate When blasts are no longer present in the spinal fluid patients receive methotrexate IT or intraventricularly once weekly for 4 weeks and then once monthly for 1 year
Patients are reevaluated on day 28 Patients who achieve A1 bone marrow status and B1 peripheral blood status or those with resistant disease proceed to second induction therapy
Second induction chemotherapy Patients receive high-dose cytarabine IV on days 1-5 mitoxantrone IV on day 3 and filgrastim G-CSF SC or IV beginning on day 7 and continuing until blood counts recover Patients with CNS leukemia also receive methotrexate and leucovorin calcium as in first induction chemotherapy
Patients are reevaluated on day 28 Patients who achieve A1 bone marrow status and B1 peripheral blood status with no extramedullary disease other than CNS involvement proceed to consolidation chemotherapy Patients with resistant disease OR Philadelphia chromosome- or BCRABL-positive disease are removed from the study after receiving double induction chemotherapy
Consolidation chemotherapy Patients receive cyclophosphamide IV on days 1 15 and 29 cytarabine IV on days 2-5 and 16-19 oral mercaptopurine on days 1-28 and methotrexate IT or intraventricularly on days 2 9 16 and 23 Patients with CNS leukemia also undergo cranial radiotherapy once daily 5 days a week for 2 weeks
Patients in complete remission proceed to maintenance chemotherapy
Maintenance chemotherapy
Course 1 Patients receive oral mercaptopurine on days 1-63 and oral methotrexate on days 1 8 15 22 29 36 43 50 and 57 Patients proceed to course 2 after blood counts recover
Course 2 Patients receive vincristine IV and doxorubicin IV on days 1 8 15 and 22 and oral dexamethasone on days 1-28 Patients proceed to course 3 after blood counts recover
Course 3 Patients receive cyclophosphamide IV on day 1 oral thioguanine on days 1-14 and cytarabine IV on days 3-6 and 10-13 Patients proceed to course 4 after blood counts recover
Course 4 Patients receive oral mercaptopurine once daily for 2 years and oral methotrexate once weekly for 2 years
Treatment continues in the absence of disease relapse or unacceptable toxicity
After completion of study therapy patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 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 |
|---|---|---|---|
| S0333 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |