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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00557193




Registration number
NCT00557193
Ethics application status
Date submitted
9/11/2007
Date registered
12/11/2007

Titles & IDs
Public title
Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Scientific title
A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807)
Secondary ID [1] 0 0
NCI-2009-00313
Secondary ID [2] 0 0
AALL0631
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia 0 0
Acute Undifferentiated Leukemia 0 0
Childhood T Acute Lymphoblastic Leukemia 0 0
Condition category
Condition code
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
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Asparaginase
Treatment: Surgery - Biospecimen Collection
Treatment: Surgery - Bone Marrow Biopsy
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Daunorubicin Hydrochloride
Treatment: Drugs - Dexamethasone
Treatment: Surgery - Echocardiography
Treatment: Drugs - Etoposide
Treatment: Other - Filgrastim
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Lestaurtinib
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Methylprednisolone
Treatment: Surgery - Multigated Acquisition Scan
Treatment: Drugs - Pegaspargase
Other interventions - Pharmacological Study
Treatment: Drugs - Prednisone
Treatment: Drugs - Therapeutic Hydrocortisone
Treatment: Drugs - Vincristine Sulfate

Experimental: Arm A (standard risk MLL-G) - Population Description: Eligible patients with MLL-G (germline, or non-rearranged)

Active comparator: Arm B (IR/HR MLL-R chemotherapy) - Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis.

Experimental: Arm C (IR/HR MLL-R chemotherapy and lestaurtinib) - Population Description: Eligible patients with MLL-R (rearranged). Considered Intermediate Risk (IR) if age \>= 90 days at diagnosis and High Risk (HR) if age \< 90 days at diagnosis.


Treatment: Drugs: Asparaginase
Given IV, IM, or PO

Treatment: Surgery: Biospecimen Collection
Undergo blood sample collection

Treatment: Surgery: Bone Marrow Biopsy
Undergo bone marrow biopsy

Treatment: Drugs: Cyclophosphamide
Given IV

Treatment: Drugs: Cytarabine
Given IV or IT

Treatment: Drugs: Daunorubicin Hydrochloride
Given IV

Treatment: Drugs: Dexamethasone
Given IV or PO

Treatment: Surgery: Echocardiography
Undergo ECHO

Treatment: Drugs: Etoposide
Given IV

Treatment: Other: Filgrastim
Given IV or SC

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Treatment: Drugs: Lestaurtinib
Given PO

Treatment: Drugs: Leucovorin Calcium
Given IV

Treatment: Drugs: Mercaptopurine
Given PO

Treatment: Drugs: Methotrexate
Given IV, IT, or PO

Treatment: Drugs: Methylprednisolone
Given IV

Treatment: Surgery: Multigated Acquisition Scan
Undergo MUGA

Treatment: Drugs: Pegaspargase
Given IM

Other interventions: Pharmacological Study
Correlative studies

Treatment: Drugs: Prednisone
Given PO

Treatment: Drugs: Therapeutic Hydrocortisone
Given IT

Treatment: Drugs: Vincristine Sulfate
Given IV
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Intervention code [3] 0 0
Treatment: Other
Intervention code [4] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
Timepoint [1] 0 0
From start of post-induction therapy for up to 10 years
Secondary outcome [1] 0 0
Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
Timepoint [1] 0 0
From start of post-induction therapy for up to 10 years.
Secondary outcome [2] 0 0
Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)
Timepoint [2] 0 0
Up to 12 weeks from start of induction
Secondary outcome [3] 0 0
Pharmacokinetic AGP Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
Timepoint [3] 0 0
Up to 12 weeks
Secondary outcome [4] 0 0
Pharmacokinetic Albumin in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
Timepoint [4] 0 0
Up to 12 weeks
Secondary outcome [5] 0 0
Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
Timepoint [5] 0 0
Sampled between weeks 6-12 from start of induction
Secondary outcome [6] 0 0
Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
Timepoint [6] 0 0
Sampled at the start of induction
Secondary outcome [7] 0 0
Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
Timepoint [7] 0 0
At relapse (up to 3 years)
Secondary outcome [8] 0 0
Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
Timepoint [8] 0 0
Sampled at the start of induction
Secondary outcome [9] 0 0
Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
Timepoint [9] 0 0
At relapse (up to 3 years)
Secondary outcome [10] 0 0
Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
Timepoint [10] 0 0
3 Years from end of Induction)
Secondary outcome [11] 0 0
Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With Survival Outcomes
Timepoint [11] 0 0
At 3 years
Secondary outcome [12] 0 0
Identification of Gene Expression Patterns in Diagnostic Infant Leukemia Samples That Correlate With PIA Values
Timepoint [12] 0 0
At 3 years
Secondary outcome [13] 0 0
Percent Probability for Event-free Survival (EFS) for Patients on Arm A
Timepoint [13] 0 0
From start of post-induction therapy for up to 10 years

Eligibility
Key inclusion criteria
* Patients must be enrolled on a Children's Oncology Group (COG) ALL Classification Study (AALL08B1) prior to enrollment on AALL0631
* Patients must be < 366 days of age at the time of diagnosis; for neonates in the first month of life, patients must be > 36 weeks gestational age at the time of diagnosis
* Patients must be newly diagnosed with acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia (AUL); patients with T-cell ALL are eligible; patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominately lymphoid
* Patients must be previously untreated with the exception of steroids and intrathecal chemotherapy; no other systemic chemotherapy may have been administered; patients receiving prior steroid therapy are eligible for study; any amount of steroid pretreatment will not affect initial induction assignment as long as the patient meets all other eligibility criteria; IT chemotherapy per protocol is allowed for patient convenience at the time of the diagnostic bone marrow or venous line placement to avoid second lumbar puncture; (note: the central nervous system [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
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
* Patients with mature B-cell ALL or acute myelogenous leukemia (AML) are NOT eligible
* Patients with Down syndrome are NOT eligible
Minimum age
No limit
Maximum age
1 Year
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2024
Sample size
Target
Accrual to date
Final
218
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 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
Kentucky
Country [17] 0 0
United States of America
State/province [17] 0 0
Louisiana
Country [18] 0 0
United States of America
State/province [18] 0 0
Maine
Country [19] 0 0
United States of America
State/province [19] 0 0
Maryland
Country [20] 0 0
United States of America
State/province [20] 0 0
Massachusetts
Country [21] 0 0
United States of America
State/province [21] 0 0
Michigan
Country [22] 0 0
United States of America
State/province [22] 0 0
Minnesota
Country [23] 0 0
United States of America
State/province [23] 0 0
Mississippi
Country [24] 0 0
United States of America
State/province [24] 0 0
Missouri
Country [25] 0 0
United States of America
State/province [25] 0 0
Nebraska
Country [26] 0 0
United States of America
State/province [26] 0 0
Nevada
Country [27] 0 0
United States of America
State/province [27] 0 0
New Hampshire
Country [28] 0 0
United States of America
State/province [28] 0 0
New Jersey
Country [29] 0 0
United States of America
State/province [29] 0 0
New Mexico
Country [30] 0 0
United States of America
State/province [30] 0 0
New York
Country [31] 0 0
United States of America
State/province [31] 0 0
North Carolina
Country [32] 0 0
United States of America
State/province [32] 0 0
North Dakota
Country [33] 0 0
United States of America
State/province [33] 0 0
Ohio
Country [34] 0 0
United States of America
State/province [34] 0 0
Oklahoma
Country [35] 0 0
United States of America
State/province [35] 0 0
Oregon
Country [36] 0 0
United States of America
State/province [36] 0 0
Pennsylvania
Country [37] 0 0
United States of America
State/province [37] 0 0
Rhode Island
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

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joanne M Hilden
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/93/NCT00557193/Prot_SAP_000.pdf
Statistical analysis plan Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/93/NCT00557193/Prot_SAP_000.pdf
Study protocol Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/93/NCT00557193/Prot_SAP_000.pdf
Statistical analysis plan Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/93/NCT00557193/Prot_SAP_000.pdf
Study protocol Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/93/NCT00557193/Prot_SAP_000.pdf
Statistical analysis plan Study Protocol and Statistical Analysis Plan https://cdn.clinicaltrials.gov/large-docs/93/NCT00557193/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/NCT00557193