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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00967057




Registration number
NCT00967057
Ethics application status
Date submitted
26/08/2009
Date registered
27/08/2009
Date last updated
12/08/2013

Titles & IDs
Public title
Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Scientific title
ALLR3: An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL)
Secondary ID [1] 0 0
CDR0000642221
Secondary ID [2] 0 0
CCLG-ALLR3
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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: Drugs - dexamethasone
Treatment: Drugs - idarubicin
Treatment: Drugs - methotrexate
Treatment: Drugs - mitoxantrone hydrochloride
Treatment: Drugs - pegaspargase
Treatment: Drugs - vincristine sulfate

Experimental: Arm I (induction therapy) - Patients receive idarubicin IV over 1 hour on days 1 and 2; oral dexamethasone twice daily on days 1-5 and 15-19; intrathecal (IT) methotrexate on days 1 and 8; vincristine sulfate IV on days 3, 10, 17, and 24; and pegaspargase intramuscularly (IM) on days 3 and 17 or asparaginase IM on days 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25.

Experimental: Arm II (induction therapy) - Patients receive mitoxantrone IV over 1 hour on days 1 and 2. Patients also receive dexamethasone, methotrexate, vincristine sulfate, and pegaspargase or asparaginase as in arm I.


Treatment: Drugs: asparaginase
Given intramuscularly

Treatment: Drugs: dexamethasone
Given orally

Treatment: Drugs: idarubicin
Given IV

Treatment: Drugs: methotrexate
Given intrathecally

Treatment: Drugs: mitoxantrone hydrochloride
Given IV

Treatment: Drugs: pegaspargase
Given intramuscularly

Treatment: Drugs: vincristine sulfate
Given IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) of United Kingdom (UK) patients stratified by risk groups
Timepoint [1] 0 0
Primary outcome [2] 0 0
Evaluation of whether a minimal residual disease (MRD) level of 10(-4) is a suitable criterion at the end of induction therapy on which to decide whether chemotherapy or stem cell transplantation will be most beneficial to patients with intermediate- ...
Timepoint [2] 0 0
Secondary outcome [1] 0 0
MRD as a surrogate marker for treatment response and PFS
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Comparison of PFS, MRD level at day 35, and toxicity as response variables in patients randomized to receive induction therapy with mitoxantrone hydrochloride or idarubicin
Timepoint [2] 0 0
Secondary outcome [3] 0 0
PFS of all patients (UK, Dutch, Australian, and New Zealand) stratified by risk groups
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Comparison of PFS and overall survival between patients enrolled in this study and patients enrolled in R2 or I-BFM
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Evaluation of whether pre-stem cell transplantation cytoreduction (FLAD) reduces tumor load and how it affects outcome following transplant
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Diagnosis of acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:

- In first relapse after treatment

- Has not yet received chemotherapy or radiotherapy for the first relapse

- Primary refractory disease

- No mature B-cell ALL

- Meets criteria for one of the following risk groups:

- Standard-risk disease: non-T-cell or T-cell ALL with late isolated extramedullary
relapse

- Intermediate-risk disease: non-T-cell ALL with early isolated extramedullary
relapse or combined marrow and extramedullary relapse; non-T-cell ALL with late
combined marrow and extramedullary relapse or isolated marrow relapse; or T-cell
ALL with early isolated extramedullary relapse

- High-risk disease: non-T-cell ALL with very early isolated extramedullary
relapse, combined marrow and extramedullary relapse, or isolated marrow relapse;
non-T-cell ALL with early isolated marrow relapse; T-cell ALL with very early
isolated extramedullary relapse, combined marrow and extramedullary relapse, or
isolated marrow relapse; T-cell ALL with early combined marrow and extramedullary
relapse or isolated marrow relapse; or T-cell ALL with late combined marrow and
extramedullary relapse or isolated marrow relapse

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior bone marrow transplant
Minimum age
1 Year
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
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
1/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
470
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
England

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Cancer and Leukaemia Group
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: 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. It is not yet known
which combination chemotherapy regimen is more effective in treating young patients with
acute lymphoblastic leukemia.

PURPOSE: This partially randomized phase III trial is studying how well combination
chemotherapy works in treating young patients with relapsed or refractory acute lymphoblastic
leukemia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00967057
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vaskar Saha, MD
Address 0 0
The Christie NHS Foundation Trust
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