Leukemia Clinical Trial
Official title:
ALLR3: An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL)
Verified date | January 2011 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 470 |
Est. completion date | December 2011 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 18 Years |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Women's and Children's Hospital | North Adelaide | South Australia |
United Kingdom | Birmingham Children's Hospital | Birmingham | England |
United Kingdom | Bristol Royal Hospital for Children | Bristol | England |
United Kingdom | Great Ormond Street Hospital for Children | London | England |
United Kingdom | Christie Hospital | Manchester | England |
United Kingdom | Southampton General Hospital | Southampton | England |
Lead Sponsor | Collaborator |
---|---|
Children's Cancer and Leukaemia Group |
Australia, United Kingdom,
Parker C, Waters R, Leighton C, Hancock J, Sutton R, Moorman AV, Ancliff P, Morgan M, Masurekar A, Goulden N, Green N, Révész T, Darbyshire P, Love S, Saha V. Effect of mitoxantrone on outcome of children with first relapse of acute lymphoblastic leukaemi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) of United Kingdom (UK) patients stratified by risk groups | No | ||
Primary | 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- ... | No | ||
Secondary | MRD as a surrogate marker for treatment response and PFS | No | ||
Secondary | 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 | No | ||
Secondary | PFS of all patients (UK, Dutch, Australian, and New Zealand) stratified by risk groups | No | ||
Secondary | Comparison of PFS and overall survival between patients enrolled in this study and patients enrolled in R2 or I-BFM | No | ||
Secondary | Evaluation of whether pre-stem cell transplantation cytoreduction (FLAD) reduces tumor load and how it affects outcome following transplant | No |
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