Hormone Therapy Plus Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia
Recruitment status was: Active, not recruiting
|First Submitted Date ICMJE||November 1, 1999|
|First Posted Date ICMJE||January 27, 2003|
|Last Update Posted Date||December 4, 2013|
|Start Date ICMJE||January 1997|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003437 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Hormone Therapy Plus Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia|
|Official Title ICMJE||Medical Research Council Working Party on Leukaemia in Children UK National Lymphoblastic Leukaemia (ALL) Trial|
RATIONALE: Hormone therapy may stop the growth of cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more cancer cells. It is not yet known which hormone therapy and chemotherapy regimen is most effective for acute lymphoblastic leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of different steroid therapy and chemotherapy regimens in treating children who have acute lymphoblastic leukemia.
OUTLINE: This is a randomized, multicenter study. Patients are randomized twice during the study: prednisolone vs dexamethasone and mercaptopurine vs thioguanine. Patients are initially stratified according to risk status (standard vs intermediate vs high). Patients are stratified at the second randomization according to gender, age (under 2 years vs 2 to 9 years vs over 9 years), WBC (under 50,000/mm^3 vs over 50,000/mm^3), steroid allocation, and early response (slow vs rapid).
Patients with verified CNS disease receive weekly intrathecal (IT) methotrexate until 2 consecutive clear cerebrospinal fluid samples have been obtained. Cranial radiotherapy is administered over 15-21 days during weeks 5-8 concurrently with methotrexate IT in the appropriate regimen. Following radiotherapy, these patients receive monthly methotrexate IT for 1 year and then every 3 months until the end of therapy.
Patients with testicular infiltration receive additional radiation fractions daily for 12 days to both testes during weeks 5-8.
Regimen A (standard-risk patients)
Regimen B (intermediate-risk patients)
Regimen C (Slow early response to regimen A or B OR high-risk patients)
PROJECTED ACCRUAL: Approximately 1,800 patients will be accrued for this study within 6 years.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Primary Purpose: Treatment
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Enrollment ICMJE||1800|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||1 Year to 18 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT00003437|
|Other Study ID Numbers ICMJE||CDR0000066464
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Medical Research Council|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||February 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP