ANZCTR - Registration

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Trial details imported from ClinicalTrials.gov

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

Registration number

NCT00408005

Ethics application status

Date submitted

4/12/2006

Date registered

5/12/2006

Date last updated

6/08/2024

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]

NCI-2009-00307

Secondary ID [2]

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

T Lymphoblastic Lymphoma

Condition category

Condition code

Cancer

Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Cancer

Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Cancer

Leukaemia - Acute leukaemia

Cancer

Leukaemia - Chronic leukaemia

Cancer

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]

Treatment: Drugs

Intervention code [2]

Other interventions

Intervention code [3]

Treatment: Other

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)

Timepoint [1]

4 years from randomization at the end of induction

Primary outcome [2]

Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)

Timepoint [2]

4 years from randomization at the end of induction

Primary outcome [3]

Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)

Timepoint [3]

4 years from randomization at the end of induction

Primary outcome [4]

Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)

Timepoint [4]

4 years from randomization at the end of induction

Primary outcome [5]

Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort

Timepoint [5]

4 years from end of induction

Secondary outcome [1]

Cumulative Incidence of CNS Relapse for T-ALL by Risk Group

Timepoint [1]

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?

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]

Royal Brisbane and Women's Hospital - Herston

Recruitment hospital [2]

Royal Children's Hospital-Brisbane - Herston

Recruitment hospital [3]

Queensland Children's Hospital - South Brisbane

Recruitment hospital [4]

Women's and Children's Hospital-Adelaide - North Adelaide

Recruitment hospital [5]

Monash Medical Center-Clayton Campus - Clayton

Recruitment hospital [6]

Royal Children's Hospital - Parkville

Recruitment hospital [7]

Princess Margaret Hospital for Children - Perth

Recruitment postcode(s) [1]

4029 - Herston

Recruitment postcode(s) [2]

4101 - South Brisbane

Recruitment postcode(s) [3]

5006 - North Adelaide

Recruitment postcode(s) [4]

3168 - Clayton

Recruitment postcode(s) [5]

3052 - Parkville

Recruitment postcode(s) [6]

6008 - Perth

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Alabama

Country [2]

United States of America

State/province [2]

Arizona

Country [3]

United States of America

State/province [3]

Arkansas

Country [4]

United States of America

State/province [4]

California

Country [5]

United States of America

State/province [5]

Colorado

Country [6]

United States of America

State/province [6]

Connecticut

Country [7]

United States of America

State/province [7]

Delaware

Country [8]

United States of America

State/province [8]

District of Columbia

Country [9]

United States of America

State/province [9]

Florida

Country [10]

United States of America

State/province [10]

Georgia

Country [11]

United States of America

State/province [11]

Hawaii

Country [12]

United States of America

State/province [12]

Idaho

Country [13]

United States of America

State/province [13]

Illinois

Country [14]

United States of America

State/province [14]

Indiana

Country [15]

United States of America

State/province [15]

Iowa

Country [16]

United States of America

State/province [16]

Kansas

Country [17]

United States of America

State/province [17]

Kentucky

Country [18]

United States of America

State/province [18]

Louisiana

Country [19]

United States of America

State/province [19]

Maine

Country [20]

United States of America

State/province [20]

Maryland

Country [21]

United States of America

State/province [21]

Massachusetts

Country [22]

United States of America

State/province [22]

Michigan

Country [23]

United States of America

State/province [23]

Minnesota

Country [24]

United States of America

State/province [24]

Mississippi

Country [25]

United States of America

State/province [25]

Missouri

Country [26]

United States of America

State/province [26]

Nebraska

Country [27]

United States of America

State/province [27]

Nevada

Country [28]

United States of America

State/province [28]

New Hampshire

Country [29]

United States of America

State/province [29]

New Jersey

Country [30]

United States of America

State/province [30]

New Mexico

Country [31]

United States of America

State/province [31]

New York

Country [32]

United States of America

State/province [32]

North Carolina

Country [33]

United States of America

State/province [33]

North Dakota

Country [34]

United States of America

State/province [34]

Ohio

Country [35]

United States of America

State/province [35]

Oklahoma

Country [36]

United States of America

State/province [36]

Oregon

Country [37]

United States of America

State/province [37]

Pennsylvania

Country [38]

United States of America

State/province [38]

South Carolina

Country [39]

United States of America

State/province [39]

South Dakota

Country [40]

United States of America

State/province [40]

Tennessee

Country [41]

United States of America

State/province [41]

Texas

Country [42]

United States of America

State/province [42]

Utah

Country [43]

United States of America

State/province [43]

Vermont

Country [44]

United States of America

State/province [44]

Virginia

Country [45]

United States of America

State/province [45]

Washington

Country [46]

United States of America

State/province [46]

West Virginia

Country [47]

United States of America

State/province [47]

Wisconsin

Country [48]

Canada

State/province [48]

Alberta

Country [49]

Canada

State/province [49]

British Columbia

Country [50]

Canada

State/province [50]

Manitoba

Country [51]

Canada

State/province [51]

Newfoundland and Labrador

Country [52]

Canada

State/province [52]

Nova Scotia

Country [53]

Canada

State/province [53]

Ontario

Country [54]

Canada

State/province [54]

Quebec

Country [55]

Canada

State/province [55]

Saskatchewan

Country [56]

New Zealand

State/province [56]

Auckland

Country [57]

New Zealand

State/province [57]

Christchurch

Country [58]

Switzerland

State/province [58]

Geneva

Country [59]

Switzerland

State/province [59]

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/study/NCT00408005

Trial related presentations / publications

Gaynon PS, Parekh C. A new standard of care for childhood T-cell acute lymphoblastic leukemia? Pediatr Blood Cancer. 2021 Oct;68(10):e29238. doi: 10.1002/pbc.29238. Epub 2021 Jul 24. No abstract available.
Dunsmore KP, Winter SS, Devidas M, Wood BL, Esiashvili N, Chen Z, Eisenberg N, Briegel N, Hayashi RJ, Gastier-Foster JM, Carroll AJ, Heerema NA, Asselin BL, Rabin KR, Zweidler-Mckay PA, Raetz EA, Loh ML, Schultz KR, Winick NJ, Carroll WL, Hunger SP. Children's Oncology Group AALL0434: A Phase III Randomized Clinical Trial Testing Nelarabine in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia. J Clin Oncol. 2020 Oct 1;38(28):3282-3293. doi: 10.1200/JCO.20.00256. Epub 2020 Aug 19.
Hayashi RJ, Winter SS, Dunsmore KP, Devidas M, Chen Z, Wood BL, Hermiston ML, Teachey DT, Perkins SL, Miles RR, Raetz EA, Loh ML, Winick NJ, Carroll WL, Hunger SP, Lim MS, Gross TG, Bollard CM. Successful Outcomes of Newly Diagnosed T Lymphoblastic Lymphoma: Results From Children's Oncology Group AALL0434. J Clin Oncol. 2020 Sep 10;38(26):3062-3070. doi: 10.1200/JCO.20.00531. Epub 2020 Jun 17.
Winter SS, Dunsmore KP, Devidas M, Wood BL, Esiashvili N, Chen Z, Eisenberg N, Briegel N, Hayashi RJ, Gastier-Foster JM, Carroll AJ, Heerema NA, Asselin BL, Gaynon PS, Borowitz MJ, Loh ML, Rabin KR, Raetz EA, Zweidler-Mckay PA, Winick NJ, Carroll WL, Hunger SP. Improved Survival for Children and Young Adults With T-Lineage Acute Lymphoblastic Leukemia: Results From the Children's Oncology Group AALL0434 Methotrexate Randomization. J Clin Oncol. 2018 Oct 10;36(29):2926-2934. doi: 10.1200/JCO.2018.77.7250. Epub 2018 Aug 23. Erratum In: J Clin Oncol. 2019 Mar 20;37(9):761. doi: 10.1200/JCO.19.00295.

Public notes

Contacts

Principal investigator

Name

Stuart S Winter

Address

Children's Oncology Group

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol	Study Protocol and Statistical Analysis Plan	https://cdn.clinicaltrials.gov/large-docs/05/NCT00408005/Prot_SAP_000.pdf
Statistical analysis plan	Study Protocol and Statistical Analysis Plan	https://cdn.clinicaltrials.gov/large-docs/05/NCT00408005/Prot_SAP_000.pdf

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00408005

Trial Review

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