A Pilot Study of Allopurinol As A Modifier of 6-MP Metabolism in Pediatric ALL
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|ClinicalTrials.gov Identifier: NCT02046694|
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : June 21, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia (ALL)||Drug: Allopurinol||Early Phase 1|
- Patients will have several visits to the Pediatric Oncology outpatient clinic. Each visit will consist of a physical examination and laboratory evaluation. Each laboratory evaluation will consist of taking approximately 10-15 milliliters of blood (or approximately three teaspoons). These clinic visits may actually coincide with clinic visits that were previously scheduled according to the patient's treatment protocol.
- At the first study visit, patients will have a physical examination and laboratory evaluation. At that visit, patients will be asked to stop taking 6-MP and methotrexate.
- At the second study visit, which is one week later, patients will again have a physical examination and laboratory evaluation. The investigators will prescribe allopurinol and restart 6-MP and methotrexate at half of the patient's previous doses.
- Clinic visits for physical examination and laboratory evaluation will be scheduled every 1-2 weeks for a total of 5 more visits. Doses of allopurinol, 6-MP, and methotrexate may be adjusted at these visits based on laboratory values or clinical symptoms.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pilot Study|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Allopurinol As A Modifier of 6-MP Metabolism in Pediatric ALL|
|Actual Study Start Date :||January 6, 2014|
|Actual Primary Completion Date :||April 6, 2020|
|Actual Study Completion Date :||April 6, 2020|
Patients will stop taking their 6-MP and methotrexate at week 0. One week later (week 1), patients will begin allopurinol daily (100 mg for weight >30 kg, 50 mg for weight ≤30 kg) and will restart 6-MP and methotrexate at 50 percent of the most recent dose. Patients will continue taking allopurinol in combination with 6-MP and methotrexate for the duration of the study (total of 8 weeks). Dose adjustments of 6-MP and methotrexate will be directed by the guidelines outlined in the study protocol.
At week 1, patients will begin allopurinol daily (100 mg for weight >30 kg, 50 mg for weight ≤30 kg) and will restart 6-MP and methotrexate at 50 percent of the most recent dose. Patients will continue taking allopurinol in combination with 6-MP and methotrexate for the duration of the study (total of 8 weeks).
Other Name: Zyloprim
- Absolute neutrophil count [ Time Frame: 8 weeks ]Absolute neutrophil count (ANC) measured 8 weeks after the addition of allopurinol (study week 9).
- Feasibility of the addition of allopurinol to ALL maintenance therapy [ Time Frame: 8 weeks ]Allopurinol compliance rate during ALL maintenance therapy.
- Safety of the addition of allopurinol to ALL maintenance therapy [ Time Frame: 8 weeks ]Occurence of grade 4 adverse events that are possibly, probably, or definitely attributable to allopurinol.
- Effects of allopurinol on liver function tests [ Time Frame: 8 weeks ]Measurement of ALT, AST, and direct bilirubin before and after adding allopurinol.
- Alteration of 6-MP metabolism through the addition of allopurinol [ Time Frame: 8 weeks ]Measurement of 6-thioguanine (6-TGN) and 6-methylmercaptopurine (6-MMP) before and after adding allopurinol.
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|Ages Eligible for Study:||up to 30 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Currently being treated in the maintenance phase of therapy for pediatric ALL
- Age ≤30 years
- 6-MMP:6-TGN ratio ≥40 within 21 days prior to enrollment
- 6-MMP ≥12,000/8x108 red blood cells (RBC) within 21 days prior to enrollment
One of the following within 21 days prior to enrollment:
- ANC persistently ≥1500/mm3 (as measured by 3 CBCs done over 6 weeks or 2 successive monthly complete blood counts (CBCs) despite 6-MP ≥150% of Children's oncology group (COG) dosing OR
Evidence of ≥ Grade 3 hepatotoxicity with one of the following:
ALT ≥5x upper limit of normal (based on institutional standards) AST ≥5x upper limit of normal (based on institutional standards) Direct bilirubin ≥5x upper limit of normal (based on institutional standards) OR
- Evidence of ≥ Grade 2 gastrointestinal toxicity (including, but not limited to: nausea, vomiting, anorexia, gastrointestinal pain)
- Allergy to allopurinol
- Active relapse of ALL or lymphoblastic lymphoma
- Currently enrolled on any therapeutic research study for the treatment of ALL or lymphoblastic lymphoma
- Known history of chronic liver disease (other than Gilbert's syndrome)
- Pregnant or breastfeeding females
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): NCT02046694
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|United States, Texas|
|Texas Children's Cancer and Hematology Centers|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Stacy Cooper, MD||Johns Hopkins University|
|Responsible Party:||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Other Study ID Numbers:||
J1357 ( Other Identifier: SKCCC at Johns Hopkins )
NA_00084984 ( Other Identifier: JHMIRB )
|First Posted:||January 28, 2014 Key Record Dates|
|Last Update Posted:||June 21, 2022|
|Last Verified:||June 2022|
acute lymphoblastic leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Free Radical Scavengers
Physiological Effects of Drugs