Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00967057|
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: asparaginase Drug: dexamethasone Drug: idarubicin Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: pegaspargase Drug: vincristine sulfate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||470 participants|
|Official Title:||ALLR3: An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL)|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||December 2011|
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.
Drug: vincristine sulfate
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.
Drug: mitoxantrone hydrochloride
Drug: vincristine sulfate
- Progression-free survival (PFS) of United Kingdom (UK) patients stratified by risk groups
- 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- ...
- MRD as a surrogate marker for treatment response and PFS
- 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
- PFS of all patients (UK, Dutch, Australian, and New Zealand) stratified by risk groups
- Comparison of PFS and overall survival between patients enrolled in this study and patients enrolled in R2 or I-BFM
- Evaluation of whether pre-stem cell transplantation cytoreduction (FLAD) reduces tumor load and how it affects outcome following transplant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967057
|Australia, South Australia|
|Women's and Children's Hospital|
|North Adelaide, South Australia, Australia, 5006|
|Birmingham Children's Hospital|
|Birmingham, England, United Kingdom, B4 6NH|
|Bristol Royal Hospital for Children|
|Bristol, England, United Kingdom, BS2 8BJ|
|Great Ormond Street Hospital for Children|
|London, England, United Kingdom, WC1N 3JH|
|Manchester, England, United Kingdom, M20 4BX|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Principal Investigator:||Vaskar Saha, MD||The Christie NHS Foundation Trust|