Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408005
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2006-12-04
Brief Title:
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Intensified Methotrexate Nelarabine Compound 506U78 and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia ALL or T-cell Lymphoblastic Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma 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 may kill more cancer cells It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma After a common induction therapy patients were risk assigned and eligible for one or both post-induction randomizations Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy No Nelarabine versus Nelarabine in Consolidation therapy T-ALL patients are risk assigned as Low Risk Intermediate Risk or High Risk Low Risk patients are not eligible for the Nelarabine randomization Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk High Risk and induction failures Standard risk patients did not receive nelarabine High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine and Induction failures were assigned to receive Nelarabine
Detailed Description:
PRIMARY OBJECTIVES
I To determine through randomization the relative safety and efficacy of the addition of nelarabine Compound 506U78 to augmented Berlin-Frankfurt-Münster BFM therapy Regimen C Childrens Cancer Group CCG-1961
II To determine the relative safety and efficacy of high dose methotrexate 5 gm2 with leucovorin leucovorin calcium rescue compared to escalating methotrexate without leucovorin rescue plus pegaspargase Capizzi I delivered during interim maintenance
III To gain preliminary data on the use of nelarabine in patients with high risk T-cell lymphoblastic lymphoma and its effect on long-term survival
SECONDARY OBJECTIVES
I To determine the relative safety and efficacy of withholding radiation in patients with low risk T-cell acute lymphoblastic leukemia T-ALL while treating Intermediate and high risk patients with 1200 cGy of prophylactic cranial radiation
OUTLINE This is a randomized controlled factorial-group multicenter study
GROUP 0 INDUCTION THERAPY All patients T-ALL and T-LLy receive cytarabine intrathecally IT on day 1 vincristine sulfate intravenously IV on days 1 8 15 and 22 prednisone IV or orally PO twice daily BID on days 1-28 pegaspargase intramuscularly IM may give IV over 1 to 2 hours on day 4 5 or 6 duanorubicin IV on days 1 8 15 and 22 and methotrexate IT on days 8 and 29 and days 15 and 22 for patients with CNS3 disease
GROUP I ARM I COMBINATION CHEMOTHERAPY CONSOLIDATION CHEMOTHERAPY Patients receive methotrexate IT on days 1 8 15 and 22 cyclophosphamide IV over 30 minutes on days 1 and 29 cytarabine IV over 15-30 minutes or subcutaneously SC on days 1-4 8-11 29-32 and 36-39 mercaptopurine PO on days 1-14 and 29-42 vincristine sulfate IV on days 15 22 43 and 50 and pegaspargase IM or IV over 1-2 hours on days 15 and 43 Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12 15-19 and 22-26 DS patients excluded as of 092910 Patients with intermediate-risk or high-risk disease CNS1 or CNS2 undergo prophylactic CRT 1200 cGydose QD on days 15-21 and 22-28 Patients with low-risk disease do not undergo conformal radiation therapy CRT Patients with standard risk T-LLy received Arm I and those with high risk T-LLy were randomized between Arm I and Arm II combination chemotherapy
GROUP I ARM I COMBINATION CHEMOTHERAPY DELAYED INTENSIFICATION CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 8 15 43 and 50 dexamethasone IV or PO BID on days 1-21 for patients 10 years of age OR on days 1-7 and 15-21 for patients 10 years of age and for patients with DS doxorubicin hydrochloride IV on days 1 8 and 15 pegaspargase IM or IV over 1-2 hours on day 4 5 OR 6 AND day 43 methotrexate IT on days 1 29 and 36 cyclophosphamide IV over 30 minutes on day 29 cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39 and thioguanine PO on days 29-42 Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose DS patients excluded as of 092910 Standard risk T-LLy patients were assigned to Arm I and those with high risk were randomized between Arm I and Arm II
GROUP I ARM I COMBINATION CHEMOTHERAPY INTERIM MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1 11 21 31 and 41 pegaspargase IM or IV over 1-2 hours on days 2 and 22 and methotrexate IT on days 1 and 31 Patients with DS also receive leucovorin calcium PO 48 and 60 hours after each methotrexate IT dose DS patients excluded as of 092910
Note Patients with an allergy to pegaspargase receive Erwinia asparaginase on days 2 4 6 8 10 12 22 24 26 28 30 and 32
GROUP I ARM I COMBINATION CHEMOTHERAPY MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 29 and 57 prednisone PO BID on days 1-5 29-33 and 57-61 mercaptopurine PO QD on days 1-84 methotrexate PO on days 8 15 22 29 36 43 50 57 64 71 and 78 and methotrexate IT on day 1 Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy approximately week 119 for girls with T-ALL all patients with T-LLy and 3 years from the start of interim maintenance therapy approximately week 171 for boys with T-ALL
GROUP I ARM II COMBINATION CHEMOTHERAPY CONSOLIDATION CHEMOTHERAPY Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47 methotrexate IT on days 15 22 57 and 64 cyclophosphamide IV over 30 minutes on days 8 and 50 cytarabine IV over 15-30 minutes or SC on days 8-11 15-18 50-53 and 57-60 mercaptopurine PO on days 8-21 and 50-63 vincristine sulfate IV on days 22 29 64 and 71 and pegaspargase IM or IV over 1-2 hours on days 22 and 64 Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 15 22-26 and 29-33 DS patients excluded as of 092910 Patients with intermediate-risk or high-risk disease CNS1 or CNS2 undergo prophylactic CRT QD on days 22-28 and 29-35 Patients with high risk T-LLy were either randomized to Arm I or Arm II Patients with T-LLy who failed induction therapy were assigned to Arm II
GROUP I ARM II COMBINATION CHEMOTHERAPY DELAYED INTENSIFICATION CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 8 15 and 50 dexamethasone IV or PO BID on days 1-21 for patients 10 years of age OR on days 1-7 and 15-21 for patients 10 years of age doxorubicin hydrochloride IV on days 1 8 and 15 pegaspargase IM or IV over 1-2 hours on day 4 5 OR 6 AND day 50 methotrexate IT on days 1 36 and 43 nelarabine IV over 60 minutes on days 29-33 cyclophosphamide IV over 30 minutes on day 36 cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46 and thioguanine PO on days 36-49
GROUP I ARM II COMBINATION CHEMOTHERAPY INTERIM MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1 11 21 31 and 41 pegaspargase IM or IV over 1-2 hours on days 2 and 22 and methotrexate IT on days 1 and 31
Note Patients with an allergy to pegaspargase receive Erwinia asparaginase on Monday Wednesday and Friday for two consecutive weeks starting the day of asparaginase substitution
GROUP I ARM II COMBINATION CHEMOTHERAPY MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate prednisone mercaptopurine methotrexate PO methotrexate IT and nelarabine in Cycles 1 2 and 3 Patients then receive treatment without nelarabine as follows vincristine sulfate prednisone mercaptopurine methotrexate PO and methotrexate IT as in arm II Treatment without nelarabine repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy approximately week 121 for girls with T-ALL and for those with T-LLY and 3 years from the start of interim maintenance therapy approximately week 173 for boys with T-ALL
GROUP I ARM III COMBINATION CHEMOTHERAPY CONSOLIDATION CHEMOTHERAPY Patients receive methotrexate IT on days 1 8 15 and 22 cyclophosphamide IV over 30 minutes on days 1 and 29 cytarabine IV over 15-30 minutes or SC on days 1-4 8-11 29-32 and 36-39 mercaptopurine PO on days 1-14 and 29-42 vincristine sulfate IV on days 15 22 43 and 50 and pegaspargase IM or IV over 1-2 hours on days 15 and 43 Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12 15-19 and 22-26 DS patients excluded as of 092910 Patients with intermediate-risk or high-risk disease CNS1 or CNS2 undergo prophylactic CRT 1200 cGydose QD on days 15-21 and 22-28 Patients with low-risk disease do not undergo CRT
GROUP I ARM III COMBINATION CHEMOTHERAPY DELAYED INTENSIFICATION CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 8 15 43 and 50 dexamethasone IV or PO BID on days 1-21 for patients 10 years of age OR on days 1-7 and 15-21 for patients 10 years of age and for patients with DS doxorubicin hydrochloride IV on days 1 8 and 15 pegaspargase IM or IV over 1-2 hours on day 4 5 OR 6 AND day 43 methotrexate IT on days 1 29 and 36 cyclophosphamide IV over 30 minutes on day 29 cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39 and thioguanine PO on days 29-42 Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose DS patients excluded as of 092910
GROUP I ARM III COMBINATION CHEMOTHERAPY INTERIM MAINTENANCE CHEMOTHERAPY Patients receive high dose methotrexate HDMTX IV over 24 hours and vincristine sulfate IV on days 1 15 29 and 43 mercaptopurine PO on days 1-56 and methotrexate IT on days 1 and 29 Beginning 42 hours after the start of HDMTX patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses
GROUP I ARM III COMBINATION CHEMOTHERAPY MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 29 and 57 prednisone PO BID on days 1-5 29-33 and 57-61 mercaptopurine PO QD on days 1-84 methotrexate PO on days 8 15 22 29 36 43 50 57 64 71 and 78 and methotrexate IT on day 1 Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy approximately week 119 for girls with T-ALL and all patients with T-LLy and 3 years from the start of interim maintenance therapy approximately week 171 for boys with T-ALL
GROUP I ARM IV COMBINATION CHEMOTHERAPY CONSOLIDATION CHEMOTHERAPY Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47 methotrexate IT on days 15 22 57 and 64 cyclophosphamide IV over 30 minutes on days 8 and 50 cytarabine IV over 15-30 minutes or SC on days 8-11 15-18 50-53 and 57-60 mercaptopurine PO on days 8-21 and 50-63 vincristine sulfate IV on days 22 29 64 and 71 and pegaspargase IM or IV over 1-2 hours on days 22 and 64 DS patients excluded as of 092910 Patients with intermediate-risk or high-risk disease CNS1 or CNS2 undergo prophylactic CRT QD on days 22-28 and 29-35
GROUP I ARM IV COMBINATION CHEMOTHERAPY DELAYED INTENSIFICATION CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 8 15 and 50 dexamethasone IV or PO BID on days 1-21 for patients 10 years of age OR on days 1-7 and 15-21 for patients 10 years of age doxorubicin hydrochloride IV on days 1 8 and 15 pegaspargase IM or IV over 1-2 hours on day 4 5 OR 6 AND day 50 methotrexate IT on days 1 36 and 43 nelarabine IV over 60 minutes on days 29-33 cyclophosphamide IV over 30 minutes on day 36 cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46 and thioguanine PO on days 36-49
GROUP I ARM IV COMBINATION CHEMOTHERAPY INTERIM MAINTENANCE CHEMOTHERAPY Patients receive HDMTX IV over 24 hours and vincristine sulfate IV on days 1 15 29 and 43 mercaptopurine PO on days 1-56 and methotrexate IT on days 1 and 29 Beginning 42 hours after the start of HDMTX patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses
GROUP I ARM IV COMBINATION CHEMOTHERAPY MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate prednisone mercaptopurine methotrexate PO methotrexate IT and nelarabine in Cycles 1 2 and 3 Patients then receive treatment without nelarabine as follows vincristine sulfate prednisone mercaptopurine methotrexate PO and methotrexate IT as in arm II Treatment without nelarabine repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy approximately week 121 for girls with T-ALL and for those with T-LLY and 3 years from the start of interim maintenance therapy approximately week 173 for boys with T-ALL
After completion of study therapy patients are followed periodically for at least 10 years
I To determine through randomization the relative safety and efficacy of the addition of nelarabine Compound 506U78 to augmented Berlin-Frankfurt-Münster BFM therapy Regimen C Childrens Cancer Group CCG-1961
II To determine the relative safety and efficacy of high dose methotrexate 5 gm2 with leucovorin leucovorin calcium rescue compared to escalating methotrexate without leucovorin rescue plus pegaspargase Capizzi I delivered during interim maintenance
III To gain preliminary data on the use of nelarabine in patients with high risk T-cell lymphoblastic lymphoma and its effect on long-term survival
SECONDARY OBJECTIVES
I To determine the relative safety and efficacy of withholding radiation in patients with low risk T-cell acute lymphoblastic leukemia T-ALL while treating Intermediate and high risk patients with 1200 cGy of prophylactic cranial radiation
OUTLINE This is a randomized controlled factorial-group multicenter study
GROUP 0 INDUCTION THERAPY All patients T-ALL and T-LLy receive cytarabine intrathecally IT on day 1 vincristine sulfate intravenously IV on days 1 8 15 and 22 prednisone IV or orally PO twice daily BID on days 1-28 pegaspargase intramuscularly IM may give IV over 1 to 2 hours on day 4 5 or 6 duanorubicin IV on days 1 8 15 and 22 and methotrexate IT on days 8 and 29 and days 15 and 22 for patients with CNS3 disease
GROUP I ARM I COMBINATION CHEMOTHERAPY CONSOLIDATION CHEMOTHERAPY Patients receive methotrexate IT on days 1 8 15 and 22 cyclophosphamide IV over 30 minutes on days 1 and 29 cytarabine IV over 15-30 minutes or subcutaneously SC on days 1-4 8-11 29-32 and 36-39 mercaptopurine PO on days 1-14 and 29-42 vincristine sulfate IV on days 15 22 43 and 50 and pegaspargase IM or IV over 1-2 hours on days 15 and 43 Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12 15-19 and 22-26 DS patients excluded as of 092910 Patients with intermediate-risk or high-risk disease CNS1 or CNS2 undergo prophylactic CRT 1200 cGydose QD on days 15-21 and 22-28 Patients with low-risk disease do not undergo conformal radiation therapy CRT Patients with standard risk T-LLy received Arm I and those with high risk T-LLy were randomized between Arm I and Arm II combination chemotherapy
GROUP I ARM I COMBINATION CHEMOTHERAPY DELAYED INTENSIFICATION CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 8 15 43 and 50 dexamethasone IV or PO BID on days 1-21 for patients 10 years of age OR on days 1-7 and 15-21 for patients 10 years of age and for patients with DS doxorubicin hydrochloride IV on days 1 8 and 15 pegaspargase IM or IV over 1-2 hours on day 4 5 OR 6 AND day 43 methotrexate IT on days 1 29 and 36 cyclophosphamide IV over 30 minutes on day 29 cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39 and thioguanine PO on days 29-42 Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose DS patients excluded as of 092910 Standard risk T-LLy patients were assigned to Arm I and those with high risk were randomized between Arm I and Arm II
GROUP I ARM I COMBINATION CHEMOTHERAPY INTERIM MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1 11 21 31 and 41 pegaspargase IM or IV over 1-2 hours on days 2 and 22 and methotrexate IT on days 1 and 31 Patients with DS also receive leucovorin calcium PO 48 and 60 hours after each methotrexate IT dose DS patients excluded as of 092910
Note Patients with an allergy to pegaspargase receive Erwinia asparaginase on days 2 4 6 8 10 12 22 24 26 28 30 and 32
GROUP I ARM I COMBINATION CHEMOTHERAPY MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 29 and 57 prednisone PO BID on days 1-5 29-33 and 57-61 mercaptopurine PO QD on days 1-84 methotrexate PO on days 8 15 22 29 36 43 50 57 64 71 and 78 and methotrexate IT on day 1 Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy approximately week 119 for girls with T-ALL all patients with T-LLy and 3 years from the start of interim maintenance therapy approximately week 171 for boys with T-ALL
GROUP I ARM II COMBINATION CHEMOTHERAPY CONSOLIDATION CHEMOTHERAPY Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47 methotrexate IT on days 15 22 57 and 64 cyclophosphamide IV over 30 minutes on days 8 and 50 cytarabine IV over 15-30 minutes or SC on days 8-11 15-18 50-53 and 57-60 mercaptopurine PO on days 8-21 and 50-63 vincristine sulfate IV on days 22 29 64 and 71 and pegaspargase IM or IV over 1-2 hours on days 22 and 64 Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 15 22-26 and 29-33 DS patients excluded as of 092910 Patients with intermediate-risk or high-risk disease CNS1 or CNS2 undergo prophylactic CRT QD on days 22-28 and 29-35 Patients with high risk T-LLy were either randomized to Arm I or Arm II Patients with T-LLy who failed induction therapy were assigned to Arm II
GROUP I ARM II COMBINATION CHEMOTHERAPY DELAYED INTENSIFICATION CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 8 15 and 50 dexamethasone IV or PO BID on days 1-21 for patients 10 years of age OR on days 1-7 and 15-21 for patients 10 years of age doxorubicin hydrochloride IV on days 1 8 and 15 pegaspargase IM or IV over 1-2 hours on day 4 5 OR 6 AND day 50 methotrexate IT on days 1 36 and 43 nelarabine IV over 60 minutes on days 29-33 cyclophosphamide IV over 30 minutes on day 36 cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46 and thioguanine PO on days 36-49
GROUP I ARM II COMBINATION CHEMOTHERAPY INTERIM MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate IV and escalating doses of methotrexate IV on days 1 11 21 31 and 41 pegaspargase IM or IV over 1-2 hours on days 2 and 22 and methotrexate IT on days 1 and 31
Note Patients with an allergy to pegaspargase receive Erwinia asparaginase on Monday Wednesday and Friday for two consecutive weeks starting the day of asparaginase substitution
GROUP I ARM II COMBINATION CHEMOTHERAPY MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate prednisone mercaptopurine methotrexate PO methotrexate IT and nelarabine in Cycles 1 2 and 3 Patients then receive treatment without nelarabine as follows vincristine sulfate prednisone mercaptopurine methotrexate PO and methotrexate IT as in arm II Treatment without nelarabine repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy approximately week 121 for girls with T-ALL and for those with T-LLY and 3 years from the start of interim maintenance therapy approximately week 173 for boys with T-ALL
GROUP I ARM III COMBINATION CHEMOTHERAPY CONSOLIDATION CHEMOTHERAPY Patients receive methotrexate IT on days 1 8 15 and 22 cyclophosphamide IV over 30 minutes on days 1 and 29 cytarabine IV over 15-30 minutes or SC on days 1-4 8-11 29-32 and 36-39 mercaptopurine PO on days 1-14 and 29-42 vincristine sulfate IV on days 15 22 43 and 50 and pegaspargase IM or IV over 1-2 hours on days 15 and 43 Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy on days 11-12 15-19 and 22-26 DS patients excluded as of 092910 Patients with intermediate-risk or high-risk disease CNS1 or CNS2 undergo prophylactic CRT 1200 cGydose QD on days 15-21 and 22-28 Patients with low-risk disease do not undergo CRT
GROUP I ARM III COMBINATION CHEMOTHERAPY DELAYED INTENSIFICATION CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 8 15 43 and 50 dexamethasone IV or PO BID on days 1-21 for patients 10 years of age OR on days 1-7 and 15-21 for patients 10 years of age and for patients with DS doxorubicin hydrochloride IV on days 1 8 and 15 pegaspargase IM or IV over 1-2 hours on day 4 5 OR 6 AND day 43 methotrexate IT on days 1 29 and 36 cyclophosphamide IV over 30 minutes on day 29 cytarabine IV over 15-30 minutes or SC on days 29-32 and 36-39 and thioguanine PO on days 29-42 Patients with DS also receive leucovorin calcium PO at 48 and 60 hours after each methotrexate dose DS patients excluded as of 092910
GROUP I ARM III COMBINATION CHEMOTHERAPY INTERIM MAINTENANCE CHEMOTHERAPY Patients receive high dose methotrexate HDMTX IV over 24 hours and vincristine sulfate IV on days 1 15 29 and 43 mercaptopurine PO on days 1-56 and methotrexate IT on days 1 and 29 Beginning 42 hours after the start of HDMTX patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses
GROUP I ARM III COMBINATION CHEMOTHERAPY MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 29 and 57 prednisone PO BID on days 1-5 29-33 and 57-61 mercaptopurine PO QD on days 1-84 methotrexate PO on days 8 15 22 29 36 43 50 57 64 71 and 78 and methotrexate IT on day 1 Treatment repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy approximately week 119 for girls with T-ALL and all patients with T-LLy and 3 years from the start of interim maintenance therapy approximately week 171 for boys with T-ALL
GROUP I ARM IV COMBINATION CHEMOTHERAPY CONSOLIDATION CHEMOTHERAPY Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47 methotrexate IT on days 15 22 57 and 64 cyclophosphamide IV over 30 minutes on days 8 and 50 cytarabine IV over 15-30 minutes or SC on days 8-11 15-18 50-53 and 57-60 mercaptopurine PO on days 8-21 and 50-63 vincristine sulfate IV on days 22 29 64 and 71 and pegaspargase IM or IV over 1-2 hours on days 22 and 64 DS patients excluded as of 092910 Patients with intermediate-risk or high-risk disease CNS1 or CNS2 undergo prophylactic CRT QD on days 22-28 and 29-35
GROUP I ARM IV COMBINATION CHEMOTHERAPY DELAYED INTENSIFICATION CHEMOTHERAPY Patients receive vincristine sulfate IV on days 1 8 15 and 50 dexamethasone IV or PO BID on days 1-21 for patients 10 years of age OR on days 1-7 and 15-21 for patients 10 years of age doxorubicin hydrochloride IV on days 1 8 and 15 pegaspargase IM or IV over 1-2 hours on day 4 5 OR 6 AND day 50 methotrexate IT on days 1 36 and 43 nelarabine IV over 60 minutes on days 29-33 cyclophosphamide IV over 30 minutes on day 36 cytarabine IV over 15-30 minutes or SC on days 36-39 and 43-46 and thioguanine PO on days 36-49
GROUP I ARM IV COMBINATION CHEMOTHERAPY INTERIM MAINTENANCE CHEMOTHERAPY Patients receive HDMTX IV over 24 hours and vincristine sulfate IV on days 1 15 29 and 43 mercaptopurine PO on days 1-56 and methotrexate IT on days 1 and 29 Beginning 42 hours after the start of HDMTX patients also receive leucovorin calcium IV or PO once every 6 hours for 3 doses
GROUP I ARM IV COMBINATION CHEMOTHERAPY MAINTENANCE CHEMOTHERAPY Patients receive vincristine sulfate prednisone mercaptopurine methotrexate PO methotrexate IT and nelarabine in Cycles 1 2 and 3 Patients then receive treatment without nelarabine as follows vincristine sulfate prednisone mercaptopurine methotrexate PO and methotrexate IT as in arm II Treatment without nelarabine repeats every 84 days until the total duration of study treatment is 2 years from the start of interim maintenance therapy approximately week 121 for girls with T-ALL and for those with T-LLY and 3 years from the start of interim maintenance therapy approximately week 173 for boys with T-ALL
After completion of study therapy patients are followed periodically for at least 10 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 |
|---|---|---|---|
| U10CA180886 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180886 |
| NCI-2009-00307 | REGISTRY | None | None |
| COG-AALL0434 | None | None | None |
| 07-169 | None | None | None |
| CDR0000514500 | None | None | None |
| AALL0434 | OTHER | None | None |
| AALL0434 | OTHER | None | None |
| U10CA098543 | NIH | None | None |