Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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/study/NCT02828358
Registration number
NCT02828358
Ethics application status
Date submitted
7/07/2016
Date registered
11/07/2016
Titles & IDs
Public title
Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement
Query!
Scientific title
A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement
Query!
Secondary ID [1]
0
0
NCI-2016-00973
Query!
Secondary ID [2]
0
0
NCI-2016-00973
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Acute Leukemia of Ambiguous Lineage
0
0
Query!
B Acute Lymphoblastic Leukemia
0
0
Query!
Mixed Phenotype Acute Leukemia
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Leukaemia - Acute leukaemia
Query!
Cancer
0
0
0
0
Query!
Leukaemia - Chronic leukaemia
Query!
Cancer
0
0
0
0
Query!
Children's - Leukaemia & Lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Other
0
0
0
0
Query!
Research that is not of generic health relevance and not applicable to specific health categories listed above
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Azacitidine
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Daunorubicin
Treatment: Drugs - Daunorubicin Hydrochloride
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Hydrocortisone Sodium Succinate
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Leucovorin
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Pegaspargase
Other interventions - Pharmacological Study
Treatment: Drugs - Prednisolone
Treatment: Drugs - Thioguanine
Treatment: Drugs - Vincristine
Treatment: Drugs - Vincristine Sulfate
Experimental: Treatment (azacitidine, combination chemotherapy) - See Detailed Description
Treatment: Drugs: Azacitidine
Given IV
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Cytarabine
Given IV, SC, IT
Treatment: Drugs: Daunorubicin
Given IV
Treatment: Drugs: Daunorubicin Hydrochloride
Given IV
Treatment: Drugs: Dexamethasone
Given PO, NG, IV
Treatment: Drugs: Hydrocortisone Sodium Succinate
Given IT
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Treatment: Drugs: Leucovorin
Given PO, IV
Treatment: Drugs: Leucovorin Calcium
Given PO, IV
Treatment: Drugs: Mercaptopurine
Given PO, NG
Treatment: Drugs: Methotrexate
Given IT, IV, PO
Treatment: Drugs: Pegaspargase
Given IV
Other interventions: Pharmacological Study
Correlative studies
Treatment: Drugs: Prednisolone
Given PO, NG
Treatment: Drugs: Thioguanine
Given PO, NG
Treatment: Drugs: Vincristine
Given IV
Treatment: Drugs: Vincristine Sulfate
Given IV
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)
Query!
Assessment method [1]
0
0
Proportion of KMT2A-Rearranged patients treated with azacitidine with Dose Limiting Toxicities (DLTs) from the first course of azacitidine administration up to fourth course of azacitidine administration.
Query!
Timepoint [1]
0
0
6 months
Query!
Secondary outcome [1]
0
0
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine
Query!
Assessment method [1]
0
0
Will calculate the percentage of CpG site methylation for all patients before the first course of azacitidine. Mean and standard deviation will be reported.
Query!
Timepoint [1]
0
0
Week 6, Day 1 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)
Query!
Secondary outcome [2]
0
0
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine
Query!
Assessment method [2]
0
0
Will calculate the percentage of CpG site methylation for all patients after the first course of azacitidine. Mean and standard deviation will be reported.
Query!
Timepoint [2]
0
0
Week 6, Day 5 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)
Query!
Secondary outcome [3]
0
0
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine
Query!
Assessment method [3]
0
0
Will calculate the percentage of CpG site methylation for all patients before the second course of azacitidine. Mean and standard deviation will be reported.
Query!
Timepoint [3]
0
0
Week 13, Day 1 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)
Query!
Secondary outcome [4]
0
0
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine
Query!
Assessment method [4]
0
0
Will calculate the percentage of CpG site methylation for all patients after the second course of azacitidine. Mean and standard deviation will be reported.
Query!
Timepoint [4]
0
0
Week 13, Day 5 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)
Query!
Eligibility
Key inclusion criteria
* Infants must be > 36 weeks gestational age at the time of enrollment
* Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia) or acute leukemia of ambiguous lineage (ALUL), which includes mixed phenotype acute leukemia (MPAL); for patients with ALUL, the morphology and immunophenotype must be at least 50% B lymphoblastic
* Central nervous system (CNS) status must be determined based on a sample obtained prior to the administration of any systemic or intrathecal chemotherapy, with the exception of steroid pretreatment
Query!
Minimum age
No limit
Query!
Query!
Maximum age
364
Days
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Patients with known absence of KMT2A-rearrangement leukemia prior to enrollment
* Patients with Down syndrome
* Patients with secondary B acute lymphoblastic leukemia (B-ALL) that developed after treatment of a prior malignancy with cytotoxic chemotherapy
* With the exception of steroid pretreatment or the administration of intrathecal methotrexate or intrathecal cytarabine, receipt of any other prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL15P1
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/04/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
22/09/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
78
Query!
Recruitment in Australia
Recruitment state(s)
WA
Query!
Recruitment hospital [1]
0
0
Princess Margaret Hospital for Children - Perth
Query!
Recruitment hospital [2]
0
0
Perth Children's Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
6008 - Perth
Query!
Recruitment postcode(s) [2]
0
0
6009 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Alaska
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arizona
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Arkansas
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
California
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Colorado
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Connecticut
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Delaware
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
District of Columbia
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Florida
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Georgia
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Hawaii
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Idaho
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Illinois
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Indiana
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Iowa
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Kentucky
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Louisiana
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Maine
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Maryland
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Massachusetts
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Michigan
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Minnesota
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Mississippi
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Missouri
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Nebraska
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Nevada
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
New Hampshire
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
New Jersey
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
New York
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
North Carolina
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
North Dakota
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Ohio
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Oklahoma
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Oregon
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Pennsylvania
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Rhode Island
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
South Carolina
Query!
Country [39]
0
0
United States of America
Query!
State/province [39]
0
0
South Dakota
Query!
Country [40]
0
0
United States of America
Query!
State/province [40]
0
0
Tennessee
Query!
Country [41]
0
0
United States of America
Query!
State/province [41]
0
0
Texas
Query!
Country [42]
0
0
United States of America
Query!
State/province [42]
0
0
Utah
Query!
Country [43]
0
0
United States of America
Query!
State/province [43]
0
0
Vermont
Query!
Country [44]
0
0
United States of America
Query!
State/province [44]
0
0
Virginia
Query!
Country [45]
0
0
United States of America
Query!
State/province [45]
0
0
Washington
Query!
Country [46]
0
0
United States of America
Query!
State/province [46]
0
0
West Virginia
Query!
Country [47]
0
0
United States of America
Query!
State/province [47]
0
0
Wisconsin
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Manitoba
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Newfoundland and Labrador
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Nova Scotia
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Ontario
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Quebec
Query!
Country [53]
0
0
Puerto Rico
Query!
State/province [53]
0
0
Caguas
Query!
Country [54]
0
0
Puerto Rico
Query!
State/province [54]
0
0
San Juan
Query!
Funding & Sponsors
Primary sponsor type
Government body
Query!
Name
National Cancer Institute (NCI)
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug may kill more cancer cells.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02828358
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Erin M Guest
Query!
Address
0
0
Children's Oncology Group
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/58/NCT02828358/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/58/NCT02828358/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/NCT02828358