Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

This study is currently recruiting participants.

Verified March 2013 by National Cancer Institute (NCI)

Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00408005

First received: December 4, 2006

Last updated: March 26, 2013

Last verified: March 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Contiguous Stage II Adult Lymphoblastic Lymphoma Noncontiguous Stage II Adult Lymphoblastic Lymphoma Stage II Adult T-cell Leukemia/Lymphoma Stage II Childhood Lymphoblastic Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Adult T-cell Leukemia/Lymphoma Stage III Childhood Lymphoblastic Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Adult T-cell Leukemia/Lymphoma Stage IV Childhood Lymphoblastic Lymphoma T-cell Adult Acute Lymphoblastic Leukemia T-cell Childhood Acute Lymphoblastic Leukemia Untreated Adult Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia	Drug: doxorubicin hydrochloride Drug: cytarabine Drug: daunorubicin hydrochloride Drug: prednisone Drug: pegaspargase Drug: methotrexate Drug: leucovorin calcium Drug: cyclophosphamide Drug: mercaptopurine Drug: nelarabine Drug: asparaginase Drug: dexamethasone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy Other: laboratory biomarker analysis	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Intensified Methotrexate, Nelarabine (Compound 506U78; IND #52611) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Calcium Cancer Chronic Lymphocytic Leukemia Leukemia Lymphoma Steroids

Drug Information available for: Dexamethasone Cyclophosphamide Mercaptopurine Prednisone Methotrexate Cytarabine Thioguanine Calcium Gluconate Dexamethasone acetate Leucovorin calcium Vincristine sulfate Dexamethasone sodium phosphate Asparaginase Sulfate ion Methotrexate sodium Daunorubicin Doxorubicin Daunorubicin hydrochloride Doxorubicin hydrochloride Levoleucovorin Nelarabine Pegaspargase Daunorubicin citrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free survival (EFS) after initial remission [ Time Frame: At 4 years ] [ Designated as safety issue: No ]
This outcome can be modeled reasonably well by a linear decreasing hazard rate with no appreciable risk of failure after completion of year 4. EFS events include any type of relapse, death in remission or second malignant neoplasm. "Intent-to-treat" analyses (i.e. based on the regimen to which patients are initially randomized) will be the primary approach used to assess treatment efficacy.
Nelarabine toxicity assessment by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: From week 6 to up to week 43 ] [ Designated as safety issue: Yes ]
Compared directly to their randomized control not receiving nelarabine with additional examination of the comparison within the separate methotrexate regimen subsets. These comparisons will focus on grade 3 or higher non-hematologic toxicities. The overall incidence of selected neurologic toxicities will also be monitored since these represent an important target category for nelarabine toxicity.
Safety of combination chemotherapy with vs without nelarabine as assessed by NCI CTCAE version 4.0 [ Time Frame: From week 6 to week 43 ] [ Designated as safety issue: Yes ]
Futility testing boundaries will be used for the comparison of "Nelarabine" versus "No Nelarabine" to decide if stopping should occur for similarity of outcome. This will be tested with a Pampallona-Tsiatis type lower monitoring boundary when approximately 20%, 40%, 60% and 80% of the EFS event information is available.
Efficacy of combination chemotherapy with vs without nelarabine [ Time Frame: Assessed up to 10 years ] [ Designated as safety issue: Yes ]
"Intent-to-treat" analyses (i.e. based on the regimen to which patients are initially randomized) will be the primary approach used to assess treatment efficacy.
Safety and efficacy of high-dose methotrexate (with leucovorin calcium rescue) and mercaptopurine vs escalating-dose methotrexate (without leucovorin calcium rescue) and pegaspargase [ Time Frame: At each dose level of treatment ] [ Designated as safety issue: Yes ]
Analyses will be performed regularly to assess the possibility of an interaction effect (using a Cox regression likelihood ratio test) which will assess the four individual treatment regimens in the 2 x 2 design to see if a non-proportional hazards effect occurs for the combinations of the two main effect factors. Since the comparison of the methotrexate regimens utilizes a selection type analysis, no futility testing will be used for that comparison.

Estimated Enrollment:	1580
Study Start Date:	January 2007
Estimated Primary Completion Date:	September 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm I (Consolidation chemotherapy) Patients receive methotrexate (MTX) intrathecally (IT) on days 1, 8, 15, and 22; cyclophosphamide IV over 30 minutes on days 1 and 29; cytarabine IV or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; oral mercaptopurine on days 1-14 and 29-42; vincristine IV on days 15, 22, 43 and 50; and pegaspargase intramuscularly (IM) or IV over 1-2 hours on days 15 and 43. Patients with Down syndrome (DS) also receive oral leucovorin calcium at 48 and 60 hours after each MTX 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 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic cranial radiotherapy (CRT) (1,200 cGy/dose) once daily on days 15-21 and 22-28. Patients with low-risk disease do not undergo CRT.	Drug: doxorubicin hydrochloride Given IV Other Names: ADM ADR Adria Adriamycin PFS Adriamycin RDF Drug: cytarabine Given IT, IV, or SC Other Names: ARA-C arabinofuranosylcytosine arabinosylcytosine Cytosar-U cytosine arabinoside Drug: daunorubicin hydrochloride Given IV Other Names: Cerubidin Cerubidine daunomycin hydrochloride daunorubicin RP-13057 Drug: prednisone Given IV or orally Other Names: DeCortin Deltra Drug: pegaspargase Given intramuscularly or IV Other Names: L-asparaginase with polyethylene glycol Oncaspar PEG-ASP PEG-L-asparaginase Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: leucovorin calcium Given orally Other Names: CF CFR LV Drug: cyclophosphamide Given IV Other Names: CPM CTX Cytoxan Endoxan Endoxana Drug: mercaptopurine Given orally Other Names: 6-mercaptopurine 6-MP Leukerin MP Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Radiation: radiation therapy Some patients undergo testicular and/or prophylactic cranial RT Other Names: irradiation radiotherapy therapy, radiation Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm II (Consolidation chemotherapy) Patients receive nelarabine IV over 60 minutes on days 1-5 and 43-47; MTX IT on days 15, 22, 57, and 64; cyclophosphamide IV over 30 minutes on days 8 and 50; cytarabine IV or SC on days 8-11, 15-18, 50-53 and 57-60; oral mercaptopurine on days 8-21 and 50-63; vincristine 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 09/29/10). (Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT once daily on days 22-28 and 29-35.	Drug: doxorubicin hydrochloride Given IV Other Names: ADM ADR Adria Adriamycin PFS Adriamycin RDF Drug: cytarabine Given IT, IV, or SC Other Names: ARA-C arabinofuranosylcytosine arabinosylcytosine Cytosar-U cytosine arabinoside Drug: daunorubicin hydrochloride Given IV Other Names: Cerubidin Cerubidine daunomycin hydrochloride daunorubicin RP-13057 Drug: prednisone Given IV or orally Other Names: DeCortin Deltra Drug: pegaspargase Given intramuscularly or IV Other Names: L-asparaginase with polyethylene glycol Oncaspar PEG-ASP PEG-L-asparaginase Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: leucovorin calcium Given orally Other Names: CF CFR LV Drug: cyclophosphamide Given IV Other Names: CPM CTX Cytoxan Endoxan Endoxana Drug: mercaptopurine Given orally Other Names: 6-mercaptopurine 6-MP Leukerin MP Drug: nelarabine Given IV Other Names: 506U78 Arranon GW506U78 Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Radiation: radiation therapy Some patients undergo testicular and/or prophylactic cranial RT Other Names: irradiation radiotherapy therapy, radiation Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm III (Consolidation chemotherapy) Patients receive MTX, cyclophosphamide, cytarabine, mercaptopurine, vincristine, and pegaspargase as in arm I. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy as in arm I (DS patients excluded as of 09/29/10).	Drug: cytarabine Given IT, IV, or SC Other Names: ARA-C arabinofuranosylcytosine arabinosylcytosine Cytosar-U cytosine arabinoside Drug: daunorubicin hydrochloride Given IV Other Names: Cerubidin Cerubidine daunomycin hydrochloride daunorubicin RP-13057 Drug: prednisone Given IV or orally Other Names: DeCortin Deltra Drug: pegaspargase Given intramuscularly or IV Other Names: L-asparaginase with polyethylene glycol Oncaspar PEG-ASP PEG-L-asparaginase Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: cyclophosphamide Given IV Other Names: CPM CTX Cytoxan Endoxan Endoxana Drug: mercaptopurine Given orally Other Names: 6-mercaptopurine 6-MP Leukerin MP Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm IV (Consolidation chemotherapy) Patients receive nelarabine, MTX, cyclophosphamide, cytarabine, mercaptopurine, vincristine, and pegaspargase as in arm II. Patients with persistent testicular disease or with DS and testicular disease undergo testicular radiotherapy as in arm II (DS patients excluded as of 09/29/10).	Drug: daunorubicin hydrochloride Given IV Other Names: Cerubidin Cerubidine daunomycin hydrochloride daunorubicin RP-13057 Drug: prednisone Given IV or orally Other Names: DeCortin Deltra Drug: pegaspargase Given intramuscularly or IV Other Names: L-asparaginase with polyethylene glycol Oncaspar PEG-ASP PEG-L-asparaginase Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: cyclophosphamide Given IV Other Names: CPM CTX Cytoxan Endoxan Endoxana Drug: mercaptopurine Given orally Other Names: 6-mercaptopurine 6-MP Leukerin MP Drug: nelarabine Given IV Other Names: 506U78 Arranon GW506U78 Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm I (Interim maintenance chemotherapy) Patients receive vincristine IV and escalating doses of MTX IV on days 1, 11, 21, 31, and 41; pegaspargase* IM or IV over 1-2 hours on days 2 and 22; and MTX IT on days 1 and 31. Patients with DS also receive oral leucovorin calcium 48 and 60 hours after each MTX IT dose (DS patients excluded as of 09/29/10). 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.]	Drug: pegaspargase Given intramuscularly or IV Other Names: L-asparaginase with polyethylene glycol Oncaspar PEG-ASP PEG-L-asparaginase Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: leucovorin calcium Given orally Other Names: CF CFR LV Drug: asparaginase Other Names: ASNase Colaspase Crasnitin Elspar L-ASP Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm II (Interim maintenance chemotherapy) Patients receive vincristine, escalating doses of MTX, pegaspargase, and MTX IT as in arm I.	Drug: pegaspargase Given intramuscularly or IV Other Names: L-asparaginase with polyethylene glycol Oncaspar PEG-ASP PEG-L-asparaginase Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: leucovorin calcium Given orally Other Names: CF CFR LV Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm III (Interim maintenance chemotherapy) Patients receive high-dose methotrexate (HDMTX) IV over 24 hours and vincristine IV on days 1, 15, 29, and 43; oral mercaptopurine on days 1-56; and MTX IT on days 1 and 29. Beginning 42 hours after the start of HDMTX, patients also receive leucovorin calcium IV or orally once every 6 hours for 3 doses.	Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: leucovorin calcium Given orally Other Names: CF CFR LV Drug: mercaptopurine Given orally Other Names: 6-mercaptopurine 6-MP Leukerin MP Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm IV (Interim maintenance chemotherapy) Patients receive HDMTX, vincristine, mercaptopurine, MTX IT, and leucovorin calcium as in arm III.	Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: leucovorin calcium Given orally Other Names: CF CFR LV Drug: mercaptopurine Given orally Other Names: 6-mercaptopurine 6-MP Leukerin MP Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm I (Delayed intensification chemotherapy) Patients receive vincristine IV on days 1, 8, 15, 43, and 50; dexamethasone IV or orally twice daily 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 over 15 minutes on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6, AND day 43; MTX IT on days 1, 29, and 36; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV or SC on days 29-32 and 36-39; and oral thioguanine on days 29-42. Patients with DS also receive oral leucovorin calcium at 48 and 60 hours after each MTX dose (DS patients excluded as of 09/29/10).	Drug: doxorubicin hydrochloride Given IV Other Names: ADM ADR Adria Adriamycin PFS Adriamycin RDF Drug: cytarabine Given IT, IV, or SC Other Names: ARA-C arabinofuranosylcytosine arabinosylcytosine Cytosar-U cytosine arabinoside Drug: pegaspargase Given intramuscularly or IV Other Names: L-asparaginase with polyethylene glycol Oncaspar PEG-ASP PEG-L-asparaginase Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: leucovorin calcium Given orally Other Names: CF CFR LV Drug: cyclophosphamide Given IV Other Names: CPM CTX Cytoxan Endoxan Endoxana Drug: dexamethasone Given IV or orally Other Names: Aeroseb-Dex Decaderm Decadron DM DXM Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm II (Delayed intensification chemotherapy) Patients receive vincristine IV on days 1, 8, 15, and 50; dexamethasone IV or orally twice daily 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 over 15 minutes on days 1, 8, and 15; pegaspargase IM or IV over 1-2 hours on day 4, 5, OR 6 AND day 50; MTX 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 or SC on days 36-39 and 43-46; and oral thioguanine on days 36-49.	Drug: doxorubicin hydrochloride Given IV Other Names: ADM ADR Adria Adriamycin PFS Adriamycin RDF Drug: cytarabine Given IT, IV, or SC Other Names: ARA-C arabinofuranosylcytosine arabinosylcytosine Cytosar-U cytosine arabinoside Drug: pegaspargase Given intramuscularly or IV Other Names: L-asparaginase with polyethylene glycol Oncaspar PEG-ASP PEG-L-asparaginase Drug: cyclophosphamide Given IV Other Names: CPM CTX Cytoxan Endoxan Endoxana Drug: nelarabine Given IV Other Names: 506U78 Arranon GW506U78 Drug: dexamethasone Given IV or orally Other Names: Aeroseb-Dex Decaderm Decadron DM DXM Drug: thioguanine Given orally Other Name: 6-TG Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm III (Delayed intensification chemotherapy) Patients receive vincristine, dexamethasone, doxorubicin hydrochloride, pegaspargase, MTX IT, cyclophosphamide, cytarabine, and thioguanine as in arm I. Patients with intermediate- or high-risk disease (CNS1 or CNS2 disease) undergo prophylactic CRT (1,200 cGy/dose) once daily on days 50-54 and 57-59.	Drug: doxorubicin hydrochloride Given IV Other Names: ADM ADR Adria Adriamycin PFS Adriamycin RDF Drug: cytarabine Given IT, IV, or SC Other Names: ARA-C arabinofuranosylcytosine arabinosylcytosine Cytosar-U cytosine arabinoside Drug: pegaspargase Given intramuscularly or IV Other Names: L-asparaginase with polyethylene glycol Oncaspar PEG-ASP PEG-L-asparaginase Drug: cyclophosphamide Given IV Other Names: CPM CTX Cytoxan Endoxan Endoxana Drug: dexamethasone Given IV or orally Other Names: Aeroseb-Dex Decaderm Decadron DM DXM Drug: thioguanine Given orally Other Name: 6-TG Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS
Active Comparator: Arm IV (Delayed intensification chemotherapy) Patients receive vincristine, dexamethasone, doxorubicin hydrochloride, pegaspargase, MTX IT, nelarabine, cyclophosphamide, cytarabine, and thioguanine as in arm II. Patients with intermediate- or high-risk disease (CNS 1 or CNS2 disease) undergo prophylactic CRT on days 50-54 and 57-59.	Drug: doxorubicin hydrochloride Given IV Other Names: ADM ADR Adria Adriamycin PFS Adriamycin RDF Drug: cytarabine Given IT, IV, or SC Other Names: ARA-C arabinofuranosylcytosine arabinosylcytosine Cytosar-U cytosine arabinoside Drug: pegaspargase Given intramuscularly or IV Other Names: L-asparaginase with polyethylene glycol Oncaspar PEG-ASP PEG-L-asparaginase Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: cyclophosphamide Given IV Other Names: CPM CTX Cytoxan Endoxan Endoxana Drug: nelarabine Given IV Other Names: 506U78 Arranon GW506U78 Drug: dexamethasone Given IV or orally Other Names: Aeroseb-Dex Decaderm Decadron DM DXM Drug: thioguanine Given orally Other Name: 6-TG Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm I (Maintenance chemotherapy) Patients receive vincristine IV on days 1, 29, and 57; oral dexamethasone twice daily on days 1-5, 29-33, and 57-61; oral mercaptopurine once daily on days 1-84; oral MTX on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and MTX 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 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL).	Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: mercaptopurine Given orally Other Names: 6-mercaptopurine 6-MP Leukerin MP Drug: dexamethasone Given IV or orally Other Names: Aeroseb-Dex Decaderm Decadron DM DXM Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm II (Maintenance chemotherapy) Patients receive vincristine IV on days 1 and 57; oral dexamethasone on days 1-5 and 57-61; oral mercaptopurine once daily on days 1-84; oral MTX on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; MTX IT on day 1; and nelarabine IV over 60 minutes on days 29-33. Treatment (that includes nelarabine) repeats every 84 days for 3 courses. Patients then receive treatment (without nelarabine) as follows: vincristine IV on days 1 and 57; oral dexamethasone on days 1-5, 29-33, and 57-61; oral mercaptopurine on days 1-84; oral MTX on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; and MTX IT on day 1. 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 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL).	Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: mercaptopurine Given orally Other Names: 6-mercaptopurine 6-MP Leukerin MP Drug: nelarabine Given IV Other Names: 506U78 Arranon GW506U78 Drug: dexamethasone Given IV or orally Other Names: Aeroseb-Dex Decaderm Decadron DM DXM Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm III (Maintenance chemotherapy) Patients receive vincristine, dexamethasone, mercaptopurine, oral MTX, and MTX IT as in arm I. 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 3 years from the start of interim maintenance therapy (approximately week 171) (for boys with T-ALL).	Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: mercaptopurine Given orally Other Names: 6-mercaptopurine 6-MP Leukerin MP Drug: dexamethasone Given IV or orally Other Names: Aeroseb-Dex Decaderm Decadron DM DXM Radiation: radiation therapy Some patients undergo testicular and/or prophylactic cranial RT Other Names: irradiation radiotherapy therapy, radiation Other: laboratory biomarker analysis Correlative studies
Active Comparator: Arm IV (Maintenance chemotherapy) Patients receive vincristine, dexamethasone, mercaptopurine, oral MTX, MTX IT, and nelarabine as in arm II. Patients then receive treatment (without nelarabine) as follows: vincristine, dexamethasone, mercaptopurine, oral MTX, and MTX 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 3 years from the start of interim maintenance therapy (approximately week 173) (for boys with T-ALL).	Drug: methotrexate Given intrathecally or orally Other Names: amethopterin Folex methylaminopterin Mexate MTX Drug: mercaptopurine Given orally Other Names: 6-mercaptopurine 6-MP Leukerin MP Drug: nelarabine Given IV Other Names: 506U78 Arranon GW506U78 Drug: dexamethasone Given IV or orally Other Names: Aeroseb-Dex Decaderm Decadron DM DXM Drug: vincristine sulfate Given IV Other Names: leurocristine sulfate VCR Vincasar PFS Other: laboratory biomarker analysis Correlative studies

Show Detailed Description

Eligibility

Ages Eligible for Study:	1 Year to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed with 1 of the following:
- T-cell acute lymphoblastic leukemia (ALL), meeting the following criteria:
  - Leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation(CD19/CD22/CD20) AND express either surface or cytoplasmic CD3 or two or more of the antigens CD8,CD7, CD5, CD4, CD2 or CD1a
  - If surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including TdT, CD34, or CD99 will be assessed for expression
  - Concurrently enrolled on protocol COG-AALL03B1 and/or COG-AALL08B1
- T-lineage lymphoblastic lymphoma (T-NHL)
  - Stage II-IV disease
    - No B-lineage lymphoblastic lymphoma
    - No morphologically unclassifiable lymphoma
    - No absence of both B-cell and T-cell phenotype markers
    - No CNS3-positive or testicular involvement
No patients with ALL or T-NHL and Down syndrome
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No peripheral neurotoxicity ≥ grade 2 (for patients randomized to receive nelarabine)
No prior seizure disorder (for patients randomized to receive nelarabine)
Prior steroid therapy allowed
No prior cytotoxic chemotherapy except intrathecal cytarabine
At least 2 years since prior and no concurrent anticonvulsant therapy (for patients randomized to receive nelarabine)
No concurrent milk or citrus products during thioguanine or mercaptopurine administration
No concurrent intensity-modulated radiotherapy
No concurrent nonsteroidal anti-inflammatory drugs, penicillin, or acetylsalicylic acid-containing medications for at least 3 days after high-dose methotrexate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408005

Show 197 Study Locations

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Stuart Winter

Children's Oncology Group

More Information

No publications provided

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00408005 History of Changes
Other Study ID Numbers:	NCI-2009-00307, AALL0434, CDR0000514500, COG-AALL0434, U01CA98543
Study First Received:	December 4, 2006
Last Updated:	March 26, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Precursor Cell Lymphoblastic Leukemia-Lymphoma
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine

Cytarabine
Methotrexate
Thioguanine
Cyclophosphamide
Pegaspargase
Asparaginase
Daunorubicin
Dexamethasone
Doxorubicin
Prednisone
Vincristine
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Leucovorin

ClinicalTrials.gov processed this record on May 16, 2013

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