Neoplasms

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Leukemia, Lymphoid

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Immunologic Factors

Folinic Acid

Folate

Vitamin B9

methotrexate

medical chart review

assessment of therapy complications

Pinki Prasad, MD

RATIONALE: Gathering information about how often kidney dysfunction occurs in children and young adults receiving methotrexate for acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This research study is looking at kidney dysfunction in children and young adults who have received low-dose or intermediate-dose methotrexate for acute lymphoblastic leukemia.

OBJECTIVES:

* Examine the incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate.

OUTLINE: Medical charts are reviewed to obtain the following information: gender, age, diagnosis, regimen, day of therapy, renal function, creatinine level, mucositis, skin sloughing, methotrexate level at highest level, and number of days after intravenous methotrexate.

Kidney Dysfunction in Children and Young Adults Who Have Received Methotrexate for Acute Lymphoblastic Leukemia

Renal Dysfunction With Low to Intermediate Dose Methotrexate in Acute Lymphoblastic Leukemia Treatment

National Cancer Institute (NCI)

Vanderbilt University Medical Center

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Heart and Blood Diseases

Syndrome

Congenital Abnormalities

Hemolysis

Hemolytic-Uremic Syndrome

Leukemia, Hairy Cell

Capillary Leak Syndrome

Hemolytic Uremic Syndrome

Hairy Cell Leukemia

Systemic Capillary Leak Syndrome

Immunotoxin HA22

Archna Hale

Juan Cuevas

Travis Arculeta

Roser Calvo

This study is being conducted to satisfy a post-marketing requirement (PMR) to provide evidence characterizing 1) the safety of moxetumomab pasudotox-tdfk in patients who are 65 years of age and older and/or 2) the safety of moxetumomab pasudotox-tdfk in patients who have moderate renal impairment defined as an estimated GFR of 30-59 ml/min

The pivotal Phase 3 study (Study 1053) supported full approval of moxetumomab pasudotox-tdfk from the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a PNA, on 13 September 2018. Since HCL is a rare disease, clinical research has limited information concerning the safety of moxetumomab pasudotox-tdfk in elderly patient populations and patients with moderate renal impairment.This study is being conducted to satisfy a post-marketing requirement (PMR) to provide evidence characterizing the safety of moxetumomab in these patients.

US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)

US Post-Marketing Retrospective Observational Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)(TM)

Electrolyte and biochemical abnormalities are defined as laboratory measurements of interest that exceed local laboratory standards

Iqvia Pty Ltd

AstraZeneca

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Kidney Dysfunction in Children and Young Adults Who Have Received Methotrexate for Acute Lymphoblastic Leukemia	NCT00993135	Leukemia Renal Toxicity	methotrexate medical chart r... assessment of t...	- 21 Years	Vanderbilt University Medical Center
US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)	NCT04125290	Hairy Cell Leuk...		-	AstraZeneca
Kidney Dysfunction in Children and Young Adults Who Have Received Methotrexate for Acute Lymphoblastic Leukemia	NCT00993135	Leukemia Renal Toxicity	methotrexate medical chart r... assessment of t...	- 21 Years	Vanderbilt University Medical Center

Spots Global Cancer Trial Database for renal toxicity