Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006455
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2000-11-06
Brief Title:
Combination Chemotherapy in Treating Children With Anaplastic Large Cell Lymphoma ALCL 99
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2022-05
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:
ALCL 99
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 combination chemotherapy regimen is more effective for treating anaplastic large cell lymphoma
PURPOSE This randomized phase III trial is studying several different regimens of combination chemotherapy to compare how well they work in treating children with anaplastic large cell lymphoma
PURPOSE This randomized phase III trial is studying several different regimens of combination chemotherapy to compare how well they work in treating children with anaplastic large cell lymphoma
Detailed Description:
OBJECTIVES
Compare the event-free survival in children with anaplastic large cell lymphoma treated with various induction and maintenance chemotherapy regimens with or without vinblastine
Compare the impact of different doses and schedules of methotrexate from the Berlin-Frankfurt-Munster-K2 Protocol in terms of overall survival complete remission rate CNS relapse rate and nonlymphoma-related death and early death rates in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to country vinblastine VBL yes vs no and prognostic factors standard-risk SR vs high-risk HR disease
Beginning immediately after confirmation of diagnosis patients receive prephase therapy comprising dexamethasone DM IV or orally daily on days 1 and 2 and every 12 hours on days 3-5 cyclophosphamide CTX IV over 1 hour on days 1 and 2 and methotrexate MTX intrathecally IT doxorubicin DOX IV and hydrocortisone HC IT on day 1
Patients are then assigned to one of two treatment groups based on prognosis
Group 1 SR disease Patients are randomized to arm I or III
Arm I Patients receive treatment on arm I as defined below on day 1 and then the following courses as defined below in the following order beginning on day 6 A1 B1 A2 B2 A3 and B3
Arm III Patients receive treatment on arm III as defined below on day 1 and then the following courses as defined below in the following order beginning on day 6 regimen AM1 BM1 AM2 BM2 AM3 and BM3
Group 2 HR disease
First randomization Patients are randomized to arm I or III
Arm I Patients receive treatment on arm I as defined below on day 1 and then course A1 as defined below on day 6
Arm III Patients receive treatment on arm III as defined below on day 1 and then course AM1 as defined below on day 6
Second randomization Patients without disease progression after completion of the above therapy are randomized to arm I II III or IV
Arm I Patients receive treatment on arm I as defined below on day 1 and then the following courses as defined below in the following order after blood counts recover B1 A2 B2 A3 and B3
Arm II Patients receive treatment on arm II as defined below on day 1 and then the following courses as defined below in the following order after blood counts recover BV1 AV2 BV2 AV3 and BV3
Arm III Patients receive treatment on arm III as defined below on day 1 and then the following courses as defined below in the following order after blood counts recover BM1 AM2 BM2 AM3 and BM3
Arm IV Patients receive treatment on arm IV as defined below on day 1 and then the following courses as defined below in the following order after blood counts recover BMV1 AMV2 BMV2 AMV3 and BMV3
Patients are followed every 2 months for 1 year every 4 months for 2 years every 6 months for 2 years and then annually thereafter
DEFINITIONS
Arms I-IV are defined below
Arm I Patients receive lower dose MTX IV over 24 hours and MTX IT
Arm II Patients receive lower dose MTX IV over 24 hours and MTX IT Patients with HR disease also receive VBL IV weekly for 1 year beginning 3 weeks after initiation of course BV3
Arm III Patients receive higher dose MTX IV over 3 hours without intrathecal therapy
Arm IV Patients receive treatment as in arm III Patients with HR disease also receive VBL IV weekly for 1 year beginning 3 weeks after initiation of course BMV3
Regimens A B AV BV AM BM AMV and BMV are defined below
Regimen A courses A1 A2 and A3 Patients receive DM IV or orally every 12 hours on days 1-5 MTX IV over 24 hours on day 1 MTX IT DOX IV and HC IT beginning 2-4 hours after initiation of MTX infusion on day 1 leucovorin calcium CF IV rescue at 42 48 and 54 hours after initiation of MTX infusion ifosfamide IFF IV over 1 hour on days 1-5 before initiation of MTX infusion cytarabine ARA-C IV over 1 hour every 12 hours and etoposide VP-16 IV over 2 hours once beginning after completion of ARA-C infusion on days 4 and 5 Each course lasts 3 weeks
Regimen B courses B1 B2 and B3 Patients receive DM MTX intrathecal therapy and CF rescue as in regimen A Patients also receive CTX IV over 1 hour on days 1-5 and DOX IV over 1 hour on days 4 and 5 Each course lasts 3 weeks
Regimen AV courses AV1 AV2 and AV3 Patients receive treatment as in regimen A and VBL IV on day 1 Each course lasts 3 weeks
Regimen BV courses BV1 BV2 and BV3 Patients receive treatment as in regimen B and VBL IV as in regimen AV Each course lasts 3 weeks
Regimen AM courses AM1 AM2 and AM3 Patients receive DM IV or orally every 12 hours on days 1-5 MTX IV over 3 hours on day 1 and CF IV rescue every 6 hours for a total of 12 doses beginning 24 hours after initiation of MTX infusion Patients also receive IFF ARA-C and VP-16 as in regimen A Each course lasts 3 weeks
Regimen BM courses BM1 BM2 and BM3 Patients receive CTX and DOX as in regimen B Patients also receive DM MTX and CF rescue as in regimen AM Each course lasts 3 weeks
Regimen AMV courses AMV1 AMV2 and AMV3 Patients receive treatment as in regimen AM and VBL as in regimen AV Each course lasts 3 weeks
Regimen BMV courses BMV1 BMV2 and BMV3 Patients receive treatment as in regimen BM and VBL as in regimen AV Each course lasts 3 weeks
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study within 54-67 years
Compare the event-free survival in children with anaplastic large cell lymphoma treated with various induction and maintenance chemotherapy regimens with or without vinblastine
Compare the impact of different doses and schedules of methotrexate from the Berlin-Frankfurt-Munster-K2 Protocol in terms of overall survival complete remission rate CNS relapse rate and nonlymphoma-related death and early death rates in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to country vinblastine VBL yes vs no and prognostic factors standard-risk SR vs high-risk HR disease
Beginning immediately after confirmation of diagnosis patients receive prephase therapy comprising dexamethasone DM IV or orally daily on days 1 and 2 and every 12 hours on days 3-5 cyclophosphamide CTX IV over 1 hour on days 1 and 2 and methotrexate MTX intrathecally IT doxorubicin DOX IV and hydrocortisone HC IT on day 1
Patients are then assigned to one of two treatment groups based on prognosis
Group 1 SR disease Patients are randomized to arm I or III
Arm I Patients receive treatment on arm I as defined below on day 1 and then the following courses as defined below in the following order beginning on day 6 A1 B1 A2 B2 A3 and B3
Arm III Patients receive treatment on arm III as defined below on day 1 and then the following courses as defined below in the following order beginning on day 6 regimen AM1 BM1 AM2 BM2 AM3 and BM3
Group 2 HR disease
First randomization Patients are randomized to arm I or III
Arm I Patients receive treatment on arm I as defined below on day 1 and then course A1 as defined below on day 6
Arm III Patients receive treatment on arm III as defined below on day 1 and then course AM1 as defined below on day 6
Second randomization Patients without disease progression after completion of the above therapy are randomized to arm I II III or IV
Arm I Patients receive treatment on arm I as defined below on day 1 and then the following courses as defined below in the following order after blood counts recover B1 A2 B2 A3 and B3
Arm II Patients receive treatment on arm II as defined below on day 1 and then the following courses as defined below in the following order after blood counts recover BV1 AV2 BV2 AV3 and BV3
Arm III Patients receive treatment on arm III as defined below on day 1 and then the following courses as defined below in the following order after blood counts recover BM1 AM2 BM2 AM3 and BM3
Arm IV Patients receive treatment on arm IV as defined below on day 1 and then the following courses as defined below in the following order after blood counts recover BMV1 AMV2 BMV2 AMV3 and BMV3
Patients are followed every 2 months for 1 year every 4 months for 2 years every 6 months for 2 years and then annually thereafter
DEFINITIONS
Arms I-IV are defined below
Arm I Patients receive lower dose MTX IV over 24 hours and MTX IT
Arm II Patients receive lower dose MTX IV over 24 hours and MTX IT Patients with HR disease also receive VBL IV weekly for 1 year beginning 3 weeks after initiation of course BV3
Arm III Patients receive higher dose MTX IV over 3 hours without intrathecal therapy
Arm IV Patients receive treatment as in arm III Patients with HR disease also receive VBL IV weekly for 1 year beginning 3 weeks after initiation of course BMV3
Regimens A B AV BV AM BM AMV and BMV are defined below
Regimen A courses A1 A2 and A3 Patients receive DM IV or orally every 12 hours on days 1-5 MTX IV over 24 hours on day 1 MTX IT DOX IV and HC IT beginning 2-4 hours after initiation of MTX infusion on day 1 leucovorin calcium CF IV rescue at 42 48 and 54 hours after initiation of MTX infusion ifosfamide IFF IV over 1 hour on days 1-5 before initiation of MTX infusion cytarabine ARA-C IV over 1 hour every 12 hours and etoposide VP-16 IV over 2 hours once beginning after completion of ARA-C infusion on days 4 and 5 Each course lasts 3 weeks
Regimen B courses B1 B2 and B3 Patients receive DM MTX intrathecal therapy and CF rescue as in regimen A Patients also receive CTX IV over 1 hour on days 1-5 and DOX IV over 1 hour on days 4 and 5 Each course lasts 3 weeks
Regimen AV courses AV1 AV2 and AV3 Patients receive treatment as in regimen A and VBL IV on day 1 Each course lasts 3 weeks
Regimen BV courses BV1 BV2 and BV3 Patients receive treatment as in regimen B and VBL IV as in regimen AV Each course lasts 3 weeks
Regimen AM courses AM1 AM2 and AM3 Patients receive DM IV or orally every 12 hours on days 1-5 MTX IV over 3 hours on day 1 and CF IV rescue every 6 hours for a total of 12 doses beginning 24 hours after initiation of MTX infusion Patients also receive IFF ARA-C and VP-16 as in regimen A Each course lasts 3 weeks
Regimen BM courses BM1 BM2 and BM3 Patients receive CTX and DOX as in regimen B Patients also receive DM MTX and CF rescue as in regimen AM Each course lasts 3 weeks
Regimen AMV courses AMV1 AMV2 and AMV3 Patients receive treatment as in regimen AM and VBL as in regimen AV Each course lasts 3 weeks
Regimen BMV courses BMV1 BMV2 and BMV3 Patients receive treatment as in regimen BM and VBL as in regimen AV Each course lasts 3 weeks
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study within 54-67 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NHL200006 | None | None | None |
| FRE-IGR-ALCL99 | None | None | None |
| EU-20031 | None | None | None |