Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002766
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
1999-11-01
Brief Title:
Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase III Trial Comparing ARA-CHigh-Dose Mitoxantrone ALL-2 to A Standard VincristinePrednisone Based Regimen L-20 as Induction Therapy For Adult Patients With Acute Lymphoblastic Leukemia ALL The ALL-4 Protocol
Status:
COMPLETED
Status Verified Date:
2016-01
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 more than one drug may kill more tumor cells It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia lymphoblastic lymphoma or chronic myelogenous leukemia
PURPOSE This randomized phase III trial is studying two different chemotherapy regimens and comparing them to see how well they work in treating adults with acute lymphoblastic leukemia lymphoblastic lymphoma or chronic myelogenous leukemia
PURPOSE This randomized phase III trial is studying two different chemotherapy regimens and comparing them to see how well they work in treating adults with acute lymphoblastic leukemia lymphoblastic lymphoma or chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Compare the incidence of complete remission CR following induction with the ALL-2 regimen cytarabine and high-dose mitoxantrone vs the L-20 regimen vincristine and prednisone in previously untreated adult patients with acute lymphoblastic leukemia ALL lymphoblastic lymphoma and lymphoid blast crisis chronic myelogenous leukemia
Compare the time to CR length of hospital stay efficacy of treatment in Philadelphia chromosome-positive ALL and the proportion of patients achieving durable greater than 5 years remission in each treatment regimen
OUTLINE This is a randomized multicenter study Patients are stratified according to participating institution and antecedent lymphoid blast crisis of chronic myelogenous leukemia yes vs no Patients are randomized to one of two treatment arms
Arm I
Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5 with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4 Patients receive sargramostim GM-CSF subcutaneously or IV over 4 hours beginning on day 7 and continuing until blood counts recover
At 7-14 days following induction therapy patients receive consolidation therapy consisting of vincristine IV on days 1 8 15 22 and 29 oral prednisone 2-3 times daily on days 1-30 and methotrexate intrathecally on days 8 15 22 and 29
At 2-3 weeks following the last dose of vincristine patients receive an additional course of consolidation therapy consisting of cyclophosphamide IV on day 1 and GM-CSF subcutaneously beginning on day 3 and continuing until blood counts recover
At 3-4 weeks following the second consolidation course patients receive a third course of consolidation therapy consisting of cytarabine IV bolus on day 1 followed by continuous infusion cytarabine on days 1-4 with etoposide IV over 1 hour on days 1-3 and methotrexate intrathecally on days 2 and 4 Patients receive GM-CSF subcutaneously beginning on day 6 and continuing until blood counts recover
Following recovery from the third consolidation course patients receive a fourth consolidation course consisting of pegaspargase IV or intramuscularly IM on day 1
Following recovery from consolidation therapy patients receive 2 sequences of maintenance therapy with sequence one consisting of vincristine IV on days 1 and 8 oral prednisone 2-3 times daily on days 1-8 doxorubicin IV on day 15 oral mercaptopurine 2-3 times daily on days 36-64 oral methotrexate on days 39 46 53 and 60 dactinomycin IV on day 85 and methotrexate intrathecally on days 36 and 43
At 2 weeks following sequence one of maintenance therapy patients receive sequence two consisting of the same regimen as in the first sequence with the addition of cyclophosphamide IV and carmustine IV on day 15
Patients with CNS involvement receive whole brain radiotherapy in addition to chemotherapy regimens
Arm II
Patients receive induction therapy consisting of vincristine IV on days 1 8 15 22 and 29 oral prednisone 2-3 times daily on days 1-29 cyclophosphamide IV on day 5 doxorubicin IV on days 23-25 and 42 methotrexate intrathecally on days 3 5 13 16 32 and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover
At approximately 3 weeks following induction therapy patients receive consolidation therapy consisting of cytarabine IV bolus on day 1 followed by continuous infusion cytarabine on days 1-5 with daunorubicin IV on days 1-3 and methotrexate intrathecally on days 2 and 4 Patients receive GM-CSF subcutaneously beginning on day 7 and continuing until blood counts recover
At 6-8 weeks following the first course of consolidation therapy patients receive a second consolidation course consisting of cytarabine IV bolus on day 1 followed by continuous infusion cytarabine on days 1-4 with methotrexate IV on days 1-4 and methotrexate intrathecally on days 2 and 4 Patients receive GM-CSF subcutaneously beginning on day 6 and continuing until blood counts recover
At 6-8 weeks following the second course of consolidation therapy patients receive a third consolidation course consisting of pegaspargase IV or IM on day 1
At 3-4 weeks following the third course of consolidation therapy patients receive a fourth consolidation course consisting of cyclophosphamide IV on day 1
At 3 weeks following the completion of consolidation therapy patients receive the same maintenance regimen as in Arm I
Treatment continues in patients achieving complete response Patients in both arms receive alternating sequences of maintenance therapy over 2 years
Compare the incidence of complete remission CR following induction with the ALL-2 regimen cytarabine and high-dose mitoxantrone vs the L-20 regimen vincristine and prednisone in previously untreated adult patients with acute lymphoblastic leukemia ALL lymphoblastic lymphoma and lymphoid blast crisis chronic myelogenous leukemia
Compare the time to CR length of hospital stay efficacy of treatment in Philadelphia chromosome-positive ALL and the proportion of patients achieving durable greater than 5 years remission in each treatment regimen
OUTLINE This is a randomized multicenter study Patients are stratified according to participating institution and antecedent lymphoid blast crisis of chronic myelogenous leukemia yes vs no Patients are randomized to one of two treatment arms
Arm I
Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5 with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4 Patients receive sargramostim GM-CSF subcutaneously or IV over 4 hours beginning on day 7 and continuing until blood counts recover
At 7-14 days following induction therapy patients receive consolidation therapy consisting of vincristine IV on days 1 8 15 22 and 29 oral prednisone 2-3 times daily on days 1-30 and methotrexate intrathecally on days 8 15 22 and 29
At 2-3 weeks following the last dose of vincristine patients receive an additional course of consolidation therapy consisting of cyclophosphamide IV on day 1 and GM-CSF subcutaneously beginning on day 3 and continuing until blood counts recover
At 3-4 weeks following the second consolidation course patients receive a third course of consolidation therapy consisting of cytarabine IV bolus on day 1 followed by continuous infusion cytarabine on days 1-4 with etoposide IV over 1 hour on days 1-3 and methotrexate intrathecally on days 2 and 4 Patients receive GM-CSF subcutaneously beginning on day 6 and continuing until blood counts recover
Following recovery from the third consolidation course patients receive a fourth consolidation course consisting of pegaspargase IV or intramuscularly IM on day 1
Following recovery from consolidation therapy patients receive 2 sequences of maintenance therapy with sequence one consisting of vincristine IV on days 1 and 8 oral prednisone 2-3 times daily on days 1-8 doxorubicin IV on day 15 oral mercaptopurine 2-3 times daily on days 36-64 oral methotrexate on days 39 46 53 and 60 dactinomycin IV on day 85 and methotrexate intrathecally on days 36 and 43
At 2 weeks following sequence one of maintenance therapy patients receive sequence two consisting of the same regimen as in the first sequence with the addition of cyclophosphamide IV and carmustine IV on day 15
Patients with CNS involvement receive whole brain radiotherapy in addition to chemotherapy regimens
Arm II
Patients receive induction therapy consisting of vincristine IV on days 1 8 15 22 and 29 oral prednisone 2-3 times daily on days 1-29 cyclophosphamide IV on day 5 doxorubicin IV on days 23-25 and 42 methotrexate intrathecally on days 3 5 13 16 32 and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover
At approximately 3 weeks following induction therapy patients receive consolidation therapy consisting of cytarabine IV bolus on day 1 followed by continuous infusion cytarabine on days 1-5 with daunorubicin IV on days 1-3 and methotrexate intrathecally on days 2 and 4 Patients receive GM-CSF subcutaneously beginning on day 7 and continuing until blood counts recover
At 6-8 weeks following the first course of consolidation therapy patients receive a second consolidation course consisting of cytarabine IV bolus on day 1 followed by continuous infusion cytarabine on days 1-4 with methotrexate IV on days 1-4 and methotrexate intrathecally on days 2 and 4 Patients receive GM-CSF subcutaneously beginning on day 6 and continuing until blood counts recover
At 6-8 weeks following the second course of consolidation therapy patients receive a third consolidation course consisting of pegaspargase IV or IM on day 1
At 3-4 weeks following the third course of consolidation therapy patients receive a fourth consolidation course consisting of cyclophosphamide IV on day 1
At 3 weeks following the completion of consolidation therapy patients receive the same maintenance regimen as in Arm I
Treatment continues in patients achieving complete response Patients in both arms receive alternating sequences of maintenance therapy over 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 |
|---|---|---|---|
| NCI-V96-0881 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |
| MSKCC-96015A1 | None | None | None |