This pilot phase I trial studies how well allopurinol works in increasing the metabolism of mercaptopurine in younger patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. A common side effect of treatments for childhood acute lymphoblastic leukemia lymphoblastic lymphoma, such as mercaptopurine, is increased absolute neutrophil counts. Neutrophils are a type of white blood cells that help the body fight infection. Allopurinol may increase the metabolism of mercaptopurine, creating a more active metabolic form that increases therapeutic response. Making mercaptopurine more effective could lower the doses required to treat younger patients with acute lymphoblastic leukemia and may safely decrease the absolute neutrophil count. It may also decrease the side effects of mercaptopurine treatment by reducing the toxicity damage to the liver (hepatotoxicity). Giving allopurinol with mercaptopurine may increase the effectiveness and safety of mercaptopurine treatment in younger patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02046694.
PRIMARY OBJECTIVES:
I. To assess the feasibility of adding allopurinol to standard maintenance therapy that includes mercaptopurine (6-MP) for pediatric acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma.
II. To assess the safety of adding allopurinol to standard maintenance therapy that includes 6-MP for pediatric ALL and lymphoblastic lymphoma.
III. To gather preliminary data about the pharmacodynamics of adding allopurinol to standard maintenance therapy for pediatric ALL and lymphoblastic lymphoma.
IV. To gather preliminary data about the clinical benefits of adding allopurinol to standard maintenance therapy for pediatric ALL and lymphoblastic lymphoma.
OUTLINE:
Patients receive allopurinol orally (PO) once daily (QD) beginning 1 week after stopping mercaptopurine and methotrexate. Patients also receive concurrent mercaptopurine PO and methotrexate PO. Treatment continues for 9 weeks in the absence of disease progression or unacceptable toxicity. Patients who are tolerating therapy and would like to continue therapy after week 9 may do so at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 4 weeks.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorStacy L. Cooper
