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
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02112916
Registration number
NCT02112916
Ethics application status
Date submitted
9/04/2014
Date registered
14/04/2014
Date last updated
9/08/2024
Titles & IDs
Public title
Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
Query!
Scientific title
A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy)
Query!
Secondary ID [1]
0
0
NCI-2014-00712
Query!
Secondary ID [2]
0
0
NCI-2014-00712
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Adult T Acute Lymphoblastic Leukemia
0
0
Query!
Ann Arbor Stage II Adult Lymphoblastic Lymphoma
0
0
Query!
Ann Arbor Stage II Childhood Lymphoblastic Lymphoma
0
0
Query!
Ann Arbor Stage III Adult Lymphoblastic Lymphoma
0
0
Query!
Ann Arbor Stage III Childhood Lymphoblastic Lymphoma
0
0
Query!
Ann Arbor Stage IV Adult Lymphoblastic Lymphoma
0
0
Query!
Ann Arbor Stage IV Childhood Lymphoblastic Lymphoma
0
0
Query!
Childhood T Acute Lymphoblastic Leukemia
0
0
Query!
Condition category
Condition code
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!
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!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Bortezomib
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Daunorubicin
Treatment: Drugs - Daunorubicin Hydrochloride
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Doxorubicin Hydrochloride
Treatment: Drugs - Etoposide
Treatment: Drugs - Hydrocortisone Sodium Succinate
Treatment: Drugs - Ifosfamide
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Pegaspargase
Treatment: Other - Radiation Therapy
Treatment: Drugs - Thioguanine
Treatment: Drugs - Vincristine
Treatment: Drugs - Vincristine Sulfate
Active comparator: Arm A (combination chemotherapy) - Patients receive combination chemotherapy without bortezomib. See Detailed Description.
Experimental: Arm B (combination chemotherapy, bortezomib) - Patients receive combination chemotherapy with bortezomib (4 doses at 1.3 mg/m\^2 during Induction and 4 doses at 1.3 mg/m\^2 during Delayed Intensification). See Detailed Description.
Treatment: Drugs: Bortezomib
Given IV
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Cytarabine
Given IT, IV, or SC
Treatment: Drugs: Daunorubicin
Given IV
Treatment: Drugs: Daunorubicin Hydrochloride
Given IV
Treatment: Drugs: Dexamethasone
Given PO or IV
Treatment: Drugs: Doxorubicin
Given IV
Treatment: Drugs: Doxorubicin Hydrochloride
Given IV
Treatment: Drugs: Etoposide
Given IV
Treatment: Drugs: Hydrocortisone Sodium Succinate
Given IT
Treatment: Drugs: Ifosfamide
Given IV
Treatment: Drugs: Leucovorin Calcium
Given PO or IV
Treatment: Drugs: Mercaptopurine
Give PO
Treatment: Drugs: Methotrexate
Given IT, IV, or PO
Treatment: Drugs: Pegaspargase
Given IV
Treatment: Other: Radiation Therapy
Undergo radiation therapy
Treatment: Drugs: Thioguanine
Given PO
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
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
Query!
Assessment method [1]
0
0
EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups.
Query!
Timepoint [1]
0
0
3 years
Query!
Secondary outcome [1]
0
0
Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase
Query!
Assessment method [1]
0
0
Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Query!
Timepoint [1]
0
0
3 years from start of therapy by patient
Query!
Secondary outcome [2]
0
0
EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT)
Query!
Assessment method [2]
0
0
EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact.
Query!
Timepoint [2]
0
0
3 years
Query!
Secondary outcome [3]
0
0
Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)
Query!
Assessment method [3]
0
0
Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988
Query!
Timepoint [3]
0
0
3 years
Query!
Secondary outcome [4]
0
0
EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3
Query!
Assessment method [4]
0
0
EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact.
Query!
Timepoint [4]
0
0
3 years
Query!
Secondary outcome [5]
0
0
EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond
Query!
Assessment method [5]
0
0
EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond
Query!
Timepoint [5]
0
0
3 years
Query!
Eligibility
Key inclusion criteria
* T-ALL: T-ALL patients must be enrolled on AALL08B1 or Project:EveryChild (APEC14B1, if open for the classification of ALL patients) prior to treatment and enrollment on AALL1231
* All patients must be > 1 and < 31 years of age
* Patients must have newly diagnosed T-lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma (T-LLy) stages II-IV
* Note: 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, and are present either in peripheral blood or > 25% in the bone marrow; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including terminal deoxynucleotidyl transferase (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
* For T-LLy 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-LLy defined by the submitting institution will be accepted
* All patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Query!
Minimum age
1
Year
Query!
Query!
Maximum age
30
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-L-Ly or for any cancer diagnosis prior to the initiation of protocol therapy on AALL1231, with the exception of:
* Steroid pretreatment: prednisone or methylprednisolone for =< 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for =< 336 hours (14 days) in the 28 days prior to initiating induction chemotherapy; prior exposure to ANY steroids that occurred > 28 days before the initiation of protocol therapy does not affect eligibility; the dose of prednisone or methylprednisolone does not affect eligibility
* Intrathecal cytarabine (the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment) system chemotherapy must begin with 72 hours of this IT therapy; or
* Pretreatment with hydroxyurea; or
* 600 cGy of chest irradiation, if medically necessary
* Pre-treatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone use during sedation to prevent or treat airway edema; inhalation steroids and topical steroids are not considered pretreatment
* Pre-existing >= grade 2 sensory or motor peripheral neurotoxicity
* Uncontrolled seizure disorder
* Diagnosis of Down syndrome (Trisomy 21)
* Patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
* Lactating females who plan to breastfeed
* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
* Patient has hypersensitivity to bortezomib, boron, or mannitol
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and within 30 days of any dose of bortezomib
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
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
Parallel
Query!
Other design features
Query!
Phase
Phase 3
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
4/10/2014
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
847
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
John Hunter Children's Hospital - Hunter Regional Mail Centre
Query!
Recruitment hospital [2]
0
0
The Children's Hospital at Westmead - Westmead
Query!
Recruitment hospital [3]
0
0
Queensland Children's Hospital - South Brisbane
Query!
Recruitment hospital [4]
0
0
Women's and Children's Hospital-Adelaide - North Adelaide
Query!
Recruitment hospital [5]
0
0
Monash Medical Center-Clayton Campus - Clayton
Query!
Recruitment hospital [6]
0
0
Royal Children's Hospital - Parkville
Query!
Recruitment hospital [7]
0
0
Princess Margaret Hospital for Children - Perth
Query!
Recruitment hospital [8]
0
0
Perth Children's Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
2310 - Hunter Regional Mail Centre
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [4]
0
0
5006 - North Adelaide
Query!
Recruitment postcode(s) [5]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [6]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [7]
0
0
6008 - Perth
Query!
Recruitment postcode(s) [8]
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 Mexico
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
New York
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
North Carolina
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
North Dakota
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Ohio
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Oklahoma
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Oregon
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Pennsylvania
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
Alberta
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
British Columbia
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Manitoba
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Newfoundland and Labrador
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Nova Scotia
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Ontario
Query!
Country [54]
0
0
Canada
Query!
State/province [54]
0
0
Quebec
Query!
Country [55]
0
0
Canada
Query!
State/province [55]
0
0
Saskatchewan
Query!
Country [56]
0
0
New Zealand
Query!
State/province [56]
0
0
Auckland
Query!
Country [57]
0
0
New Zealand
Query!
State/province [57]
0
0
Christchurch
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 randomized phase III trial compares how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma. Bortezomib may help reduce the number of leukemia or lymphoma cells by blocking some of the enzymes needed for cell growth. It may also help chemotherapy work better by making cancer cells more sensitive to the drugs. It is not yet known if giving standard chemotherapy with or without bortezomib is more effective in treating newly diagnosed T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02112916
Query!
Trial related presentations / publications
Teachey DT, Devidas M, Wood BL, Chen Z, Hayashi RJ, Hermiston ML, Annett RD, Archer JH, Asselin BL, August KJ, Cho SY, Dunsmore KP, Fisher BT, Freedman JL, Galardy PJ, Harker-Murray P, Horton TM, Jaju AI, Lam A, Messinger YH, Miles RR, Okada M, Patel SI, Schafer ES, Schechter T, Singh N, Steele AC, Sulis ML, Vargas SL, Winter SS, Wood C, Zweidler-McKay P, Bollard CM, Loh ML, Hunger SP, Raetz EA. Children's Oncology Group Trial AALL1231: A Phase III Clinical Trial Testing Bortezomib in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia and Lymphoma. J Clin Oncol. 2022 Jul 1;40(19):2106-2118. doi: 10.1200/JCO.21.02678. Epub 2022 Mar 10.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
David T Teachey
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
No information has been provided regarding IPD availability
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/16/NCT02112916/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/16/NCT02112916/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02112916
Download to PDF