A Phase 2 interventional study of Allopurinol and Standard treatment in Lymphoblastic Leukemia, Acute, Childhood, sponsored by Vastra Gotaland Region. Status unknown at 3 sites in 2 countries. Open to participants aged 6 Months to 19 Years. Per ClinicalTrials.gov, last updated 2017-01-16.
Sponsored by Vastra Gotaland Region · Phase 2, Interventional, and Treatment
The study will investigate, in children with acute lymphoblastic leukemia during maintenance treatment, if addition of allopurinol to conventional oral 6-mercaptopurine and methotrexate therapy, affects erythrocyte concentrations of 6-thioguanine and 6 methylmercaptopurine. The effect on hematological and liver toxicity parameters in blood will also be investigated as well as clinical toxicity.
After one month of conventional maintenance therapy (MT) children and adolescents, treated for acute lymphoblastic leukemia on Nordic protocols and with wild type thiopurine methyltransferase (TPMT) are eligible for the study. They will first receive a 12 week phase with normal MT during which time repeated sampling of 6-mercaptopurine (6MP) metabolite levels and other laboratory parameters will be performed. After 12 weeks, allopurinol at a dose of 50 mg/sqm is added (simultaneously reducing the dose of 6MP by 50%) and during the next 12 weeks patients are monitored closely for toxicity and samples for determination of metabolite levels and hematological and liver toxicity are obtained regularly. If, after 4 weeks of allopurinol treatment, the levels of 6-thioguanine are below 200 nmol/mmol hemoglobin, the dose of allopurinol will be increased to 100 mg/sqm. Allopurinol treatment is continued for 12 weeks after which the patients switch to their original maintenance therapy.
2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 1,691 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Vastra Gotaland Region is the lead sponsor of 272 studies on the registry; 107 are open to participants now.
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Exclusion Criteria:
Standard maintenance therapy with 6 mercaptopurine and methotrexate
Drug: Standard treatment
The second 12 week phase during which allopurinol is added to oral 6-mercaptopurine and methotrexate therapy
Drug: Allopurinol
Allopurinol is added to standard oral 6-mercaptopurine and methotrexate
Oral 6-mercaptopurine and methotrexate
6-thioguanine (6TG) levels in erythrocytes
The fraction of patients with 6TG levels over 200 nmol/mmol Hb at week 13 and 25 (ie after 12 weeks standard and allopurinol treatment respectively)
Time frame: Up to week 25
Mean level of 6-thioguanine
The mean level of 6TG at week 13 and 25
Time frame: Up to week 25
Mean level of DNA-incorporated thioguanine (DNA-TGN)
The mean level of DNA-TGN at week 13 and 25
Time frame: Up to week 25
Mean level of 6-methylmercaptopurine (6MMP)
The mean level of 6MMP at week 13 and 25
Time frame: Up to week 25
Mean levels of platelets
Comparison of weighted mean of platelets in the treatment phases
Time frame: Up to week 25
Mean levels of hemoglobin
Comparison of weighted mean of hemoglobin in the treatment phases
Time frame: Up to week 25
Mean levels of absolute neutrophil count (ANC)
Comparison of weighted mean of ANC in the treatment phases
Time frame: Up to week 25
Mean levels of white blood cells (WBC)
Comparison of weighted mean of WBC in the treatment phases
Time frame: Up to week 25
Glutamate pyruvate transaminase (GPT)
Comparison of weighted means of serum GPT in the treatment phases
Time frame: Up to week 25
Bilirubin
Comparison of weighted means of serum bilirubin in the treatment phases
Time frame: Up to week 25
Hypoglycemia
Comparison of incidence of hypoglycemia and laboratory measures of metabolic disturbance during the treatment phases
Time frame: Up to week 25
Metabolic disturbance
Comparison of incidence of laboratory measures of metabolic disturbance during the treatment phases
Time frame: Up to week 25
Incidence of serious adverse events (SAE)
Comparison of the frequency of SAE in the treatment phases
Time frame: Up to week 29
Cumulative dose of 6-mercaptopurine and methotrexate
Comparison of the cumulative dose of 6MP and methotrexate and days with treatment interruption in the two treatment arms
Time frame: Up to week 29
Plan to share: No
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This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Allopurinol
Precursor Cell Lymphoblastic Leukemia-Lymphoma →