Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00408005




Registration number
NCT00408005
Ethics application status
Date submitted
4/12/2006
Date registered
5/12/2006
Date last updated
23/05/2024

Titles & IDs
Public title
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Scientific 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
Secondary ID [1] 0 0
NCI-2009-00307
Secondary ID [2] 0 0
NCI-2009-00307
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
T Acute Lymphoblastic Leukemia 0 0
T Lymphoblastic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Asparaginase
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Daunorubicin Hydrochloride
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Doxorubicin Hydrochloride
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Nelarabine
Treatment: Drugs - Pegaspargase
Treatment: Drugs - Prednisone
Treatment: Other - Radiation Therapy
Treatment: Drugs - Thioguanine
Treatment: Drugs - Vincristine Sulfate

Experimental: Group 0 Induction Therapy - All patients (T-ALL and T-LLy) receive cytarabine intrathecally (IT) on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; prednisone IV or PO twice daily BID on days 1-28; pegaspargase IM (may give IV over 1 to 2 hours) on day 4, 5, or 6; daunorubicin hydrochloride 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).

Active Comparator: Group 1 Arm IV (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 09/29/10). (Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT QD on days 22-28 and 29-35.

Active Comparator: Group I Arm I (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 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT (1,200 cGy/dose) QD on days 15-21 and 22-28. Patients with low-risk disease do not undergo 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.

Active Comparator: Group I Arm I (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 09/29/10). Standard risk T-LLy patients were assigned to Arm I and those with high risk were randomized between Arm I and Arm II.

Active Comparator: Group I Arm I (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).

Active Comparator: Group I Arm I (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 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.

Active Comparator: Group I Arm II (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 09/29/10). (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.

Active Comparator: Group I Arm II (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.

Active Comparator: Group I Arm II (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.

Active Comparator: Group I Arm II (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).

Active Comparator: Group I Arm III (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 09/29/10.) Patients with intermediate-risk or high-risk disease (CNS1 or CNS2) undergo prophylactic CRT (1,200 cGy/dose) QD on days 15-21 and 22-28. Patients with low-risk disease do not undergo CRT.

Active Comparator: Group I Arm III (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 09/29/10).

Active Comparator: Group I Arm III (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.

Active Comparator: Group I Arm III (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).

Active Comparator: Group I Arm IV (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 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.

Active Comparator: Group I Arm IV (Interim maintenance chemotherapy) - Patients receive HDMTX IV over 24 hours and vincristine 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.

Active Comparator: Group I Arm IV (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, 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).


Treatment: Drugs: Asparaginase
Given IM or IV

Treatment: Drugs: Cyclophosphamide
Given IV

Treatment: Drugs: Cytarabine
Given IT, IV, or SC

Treatment: Drugs: Daunorubicin Hydrochloride
Given IV

Treatment: Drugs: Dexamethasone
Given IV or PO

Treatment: Drugs: Doxorubicin Hydrochloride
Given IV

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Treatment: Drugs: Leucovorin Calcium
Given PO

Treatment: Drugs: Mercaptopurine
Given PO

Treatment: Drugs: Methotrexate
Given IT or PO

Treatment: Drugs: Nelarabine
Given IV

Treatment: Drugs: Pegaspargase
Given IM or IV

Treatment: Drugs: Prednisone
Given IV or PO

Treatment: Other: Radiation Therapy
Some patients undergo testicular and/or prophylactic cranial RT

Treatment: Drugs: Thioguanine
Given PO

Treatment: Drugs: Vincristine Sulfate
Given IV
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
Timepoint [1] 0 0
4 years from randomization at the end of induction
Primary outcome [2] 0 0
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)
Timepoint [2] 0 0
4 years from randomization at the end of induction
Primary outcome [3] 0 0
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
Timepoint [3] 0 0
4 years from randomization at the end of induction
Primary outcome [4] 0 0
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)
Timepoint [4] 0 0
4 years from randomization at the end of induction
Primary outcome [5] 0 0
Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
Timepoint [5] 0 0
4 years from end of induction
Secondary outcome [1] 0 0
Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
Timepoint [1] 0 0
4 years from randomization at the end of induction

Eligibility
Key inclusion criteria
- T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on
AALL0434

- Patients must have newly diagnosed T-ALL or T-lineage lymphoblastic lymphoma (T-NHL)
stage II-IV; B-lineage lymphoblastic lymphoma will not be eligible for this study; a
diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or
evidence of B-lineage derivation (cluster of differentiation [CD]19/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 transmission disequilibrium test (TdT), CD34 or CD99
will be assessed for expression; cases with uncertain expression will receive
additional review within the appropriate Children's Oncology Group (COG) reference
laboratory

- T-NHL PATIENTS:

- For T-NHL patients with tissue available for flow cytometry, the criterion for
diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e.
paraffin blocks), the methodology and criteria for immunophenotypic analysis to
establish the diagnosis of T-NHL defined by the submitting institution will be
accepted

- Prior therapy restrictions

- Patients shall have had no prior cytotoxic chemotherapy with the exception of
steroids and/or IT cytarabine

- IT chemotherapy with cytarabine is allowed prior to registration for patient
convenience; this is usually done at the time of the diagnostic bone marrow or
venous line placement to avoid a second lumbar puncture; (Note: the CNS status
must be determined based on a sample obtained prior to administration of any
systemic or intrathecal chemotherapy, except for steroid pretreatment); systemic
chemotherapy must begin within 72 hours of this IT therapy

- Patients diagnosed as having T-NHL or T-ALL with respiratory distress or
hyperleukocytosis may require steroids prior to the initiation of additional
systemic therapy; they are eligible for AALL0434 and will be stratified, based on
the initial complete blood count (CBC); steroid pretreatment may alter the risk
group assessment; if the T-ALL patient's clinical status precludes a lumbar
puncture within 48 hours of the initiation of steroid therapy, T-ALL patients
CANNOT be classified as low risk and will be Intermediate or high risk based on
the results of the day 29 marrow as above; patients with T-NHL who receive
steroid pre-treatment will be classified as high risk; the dose and duration of
previous steroid therapy should be carefully documented

- For the management of airway compromise, patients who have received emergent
chest irradiation up to 600 cGy will be eligible for this study

- Patients with a prior seizure disorder requiring anti-convulsant therapy are not
eligible to receive nelarabine; in addition, patients with pre-existing grade 2 (or
greater) peripheral neurotoxicity, as determined prior to Induction treatment by the
treating physician or a neurologist, are not eligible to receive nelarabine; these
restrictions in eligibility are designed to prevent excessive nelarabine-induced
central and peripheral neurotoxicity in at-risk patients; for the purposes of this
study, this includes any patient that has received anticonvulsant therapy to
prevent/treat seizures in the prior two years
Minimum age
1 Year
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or lactating females are ineligible

- Patients with Down syndrome are ineligible to enroll onto this study

- For T-NHL patients the following additional exclusion criteria apply:

- B-precursor lymphoblastic lymphoma

- Morphologically unclassifiable lymphoma

- Absence of both B-cell and T-cell phenotype markers in a case submitted as
lymphoblastic lymphoma

- CNS3-positive or testicular involvement

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/03/2025
Actual
Sample size
Target
Accrual to date
Final
1895
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Royal Children's Hospital-Brisbane - Herston
Recruitment hospital [3] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [5] 0 0
Monash Medical Center-Clayton Campus - Clayton
Recruitment hospital [6] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [7] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Hawaii
Country [12] 0 0
United States of America
State/province [12] 0 0
Idaho
Country [13] 0 0
United States of America
State/province [13] 0 0
Illinois
Country [14] 0 0
United States of America
State/province [14] 0 0
Indiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Iowa
Country [16] 0 0
United States of America
State/province [16] 0 0
Kansas
Country [17] 0 0
United States of America
State/province [17] 0 0
Kentucky
Country [18] 0 0
United States of America
State/province [18] 0 0
Louisiana
Country [19] 0 0
United States of America
State/province [19] 0 0
Maine
Country [20] 0 0
United States of America
State/province [20] 0 0
Maryland
Country [21] 0 0
United States of America
State/province [21] 0 0
Massachusetts
Country [22] 0 0
United States of America
State/province [22] 0 0
Michigan
Country [23] 0 0
United States of America
State/province [23] 0 0
Minnesota
Country [24] 0 0
United States of America
State/province [24] 0 0
Mississippi
Country [25] 0 0
United States of America
State/province [25] 0 0
Missouri
Country [26] 0 0
United States of America
State/province [26] 0 0
Nebraska
Country [27] 0 0
United States of America
State/province [27] 0 0
Nevada
Country [28] 0 0
United States of America
State/province [28] 0 0
New Hampshire
Country [29] 0 0
United States of America
State/province [29] 0 0
New Jersey
Country [30] 0 0
United States of America
State/province [30] 0 0
New Mexico
Country [31] 0 0
United States of America
State/province [31] 0 0
New York
Country [32] 0 0
United States of America
State/province [32] 0 0
North Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
North Dakota
Country [34] 0 0
United States of America
State/province [34] 0 0
Ohio
Country [35] 0 0
United States of America
State/province [35] 0 0
Oklahoma
Country [36] 0 0
United States of America
State/province [36] 0 0
Oregon
Country [37] 0 0
United States of America
State/province [37] 0 0
Pennsylvania
Country [38] 0 0
United States of America
State/province [38] 0 0
South Carolina
Country [39] 0 0
United States of America
State/province [39] 0 0
South Dakota
Country [40] 0 0
United States of America
State/province [40] 0 0
Tennessee
Country [41] 0 0
United States of America
State/province [41] 0 0
Texas
Country [42] 0 0
United States of America
State/province [42] 0 0
Utah
Country [43] 0 0
United States of America
State/province [43] 0 0
Vermont
Country [44] 0 0
United States of America
State/province [44] 0 0
Virginia
Country [45] 0 0
United States of America
State/province [45] 0 0
Washington
Country [46] 0 0
United States of America
State/province [46] 0 0
West Virginia
Country [47] 0 0
United States of America
State/province [47] 0 0
Wisconsin
Country [48] 0 0
Canada
State/province [48] 0 0
Alberta
Country [49] 0 0
Canada
State/province [49] 0 0
British Columbia
Country [50] 0 0
Canada
State/province [50] 0 0
Manitoba
Country [51] 0 0
Canada
State/province [51] 0 0
Newfoundland and Labrador
Country [52] 0 0
Canada
State/province [52] 0 0
Nova Scotia
Country [53] 0 0
Canada
State/province [53] 0 0
Ontario
Country [54] 0 0
Canada
State/province [54] 0 0
Quebec
Country [55] 0 0
Canada
State/province [55] 0 0
Saskatchewan
Country [56] 0 0
New Zealand
State/province [56] 0 0
Auckland
Country [57] 0 0
New Zealand
State/province [57] 0 0
Christchurch
Country [58] 0 0
Switzerland
State/province [58] 0 0
Geneva
Country [59] 0 0
Switzerland
State/province [59] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00408005
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stuart S Winter
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00408005