Type(s) of Cancer
Leukemia/Lymphoma
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
September 2017
September 2017
NCT00408005Uploaded 01-06-2021
Access via NCI by Request
PDS UID: nci-data-443
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
Provider Information
Provider Data DescriptionThere are two data submissions (NCT00408005-D1 and -D2) for PMID 30138085. This dataset, NCT00408005-D1, has one row for each patient enrolled. The dataset provides the information of consort diagram of patient enrollment, baseline characteristics, induction response, and primary outcome for the patients on AALL0434 as reported in the manuscript.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsT Acute Lymphoblastic Leukemia
T Lymphoblastic Lymphoma
T Lymphoblastic Lymphoma
Intervention TypeDrug: Asparaginase
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Nelarabine
Drug: Pegaspargase
Drug: Prednisone
Radiation: Radiation Therapy
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Nelarabine
Drug: Pegaspargase
Drug: Prednisone
Radiation: Radiation Therapy
Drug: Thioguanine
Drug: Vincristine Sulfate
Drug(s)Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Mercaptopurine
Drug: Nelarabine
Drug: Leucovorin Calcium
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Thioguanine
Drug: Asparaginase
Drug: Daunorubicin Hydrochloride
Drug: Methotrexate
Drug: Pegaspargase
Drug: Prednisone
Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Mercaptopurine
Drug: Nelarabine
Drug: Leucovorin Calcium
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Thioguanine
Drug: Asparaginase
Total Enrolled1895
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionGroup 0 Induction Therapy - Experimental
Group 1 Arm IV (Consolidation chemotherapy) - Active Comparator
Group I Arm I (Consolidation chemotherapy) - Active Comparator
Group I Arm I (Delayed intensification chemotherapy - Active Comparator
Group I Arm I (Maintenance chemotherapy) - Active Comparator
Group I Arm I (Interim maintenance chemotherapy) - Active Comparator
Group I Arm II (Consolidation chemotherapy) - Active Comparator
Group I Arm II (Delayed intensification chemotherapy) - Active Comparator
Group I Arm II (Interim maintenance chemotherapy) - Active Comparator
Group I Arm II (Maintenance chemotherapy) - Active Comparator
Group I Arm III (Consolidation chemotherapy) - Active Comparator
Group I Arm III (Delayed intensification chemotherapy) - Active Comparator
Group I Arm III (Interim maintenance chemotherapy) - Active Comparator
Group I Arm III (Maintenance chemotherapy) - Active Comparator
Group I Arm IV (Delayed intensification chemotherapy) - Active Comparator
Group I Arm IV (Interim maintenance chemotherapy) - Active Comparator
Group I Arm IV (Maintenance chemotherapy) - Active Comparator
Group 1 Arm IV (Consolidation chemotherapy) - Active Comparator
Group I Arm I (Consolidation chemotherapy) - Active Comparator
Group I Arm I (Delayed intensification chemotherapy - Active Comparator
Group I Arm I (Maintenance chemotherapy) - Active Comparator
Group I Arm I (Interim maintenance chemotherapy) - Active Comparator
Group I Arm II (Consolidation chemotherapy) - Active Comparator
Group I Arm II (Delayed intensification chemotherapy) - Active Comparator
Group I Arm II (Interim maintenance chemotherapy) - Active Comparator
Group I Arm II (Maintenance chemotherapy) - Active Comparator
Group I Arm III (Consolidation chemotherapy) - Active Comparator
Group I Arm III (Delayed intensification chemotherapy) - Active Comparator
Group I Arm III (Interim maintenance chemotherapy) - Active Comparator
Group I Arm III (Maintenance chemotherapy) - Active Comparator
Group I Arm IV (Delayed intensification chemotherapy) - Active Comparator
Group I Arm IV (Interim maintenance chemotherapy) - Active Comparator
Group I Arm IV (Maintenance chemotherapy) - Active Comparator
Secondary IDNCI-2009-00307
PubMed (PMID)34302711
32813610
32552472
30138085
32813610
32552472
30138085
Collaborator(s)N/A
Region(s)United States
Australia
Canada
New Zealand
Switzerland
Australia
Canada
New Zealand
Switzerland
Age Range1 Year to 30 Years (Child, Adult)
Files: NCT00408005-D1
Data DictionaryNCT00408005-D1-Data-Dictionary_2.pdf
DATANCT00408005-D1-Dataset_3.csv
OTHERREADME.pdf
Files: NCT00408005-D2
Data DictionaryNCT00408005-D2-Data-Dictionary_2.pdf
DATANCT00408005-D2-Dataset_2.csv
OTHERREADME.pdf
