Study in Pediatrics With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma

Stopped early · Phase 2

Conditions studied: B-Cell Pediatric ALL

In brief

The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) or B-cell lymphoblastic lymphoma.

Key facts

Study ID

NCT02227108

Run by

MedImmune LLC

People needed

37

Starts

2014-08-01

Expected to finish

2015-11-01

Last updated by the study team

2017-04-06

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Concurrent enrollment in another clinical study for cancer treatment, unless the subject is in the follow-up period from a previous study.
• Isolated testicular or CNS ALL
• Participants with mixed-lineage leukemia (MLL) gene rearrangement
• Inadequate Hepatic function
• Inadequate Renal function
• Radiologically-detected CNS lymphoma
• Participants with clear laboratory or clinical evidence of disseminated intravascular coagulation (DIC)
• Hyperleukocytosis or rapidly progressive disease that would compromise ability to complete study therapy
• QT interval corrected using Fridericia's formula (QTcF) greater than or equal to a Grade 2, confirmed by 2 additional seperate electrocardiographs (ECG's) within 28 days prior to starting study drug. The initial screening ECG need not be repeated for confirmation if the QTcF interval is <481 milliseconds.
• Pregnant or breast-feeding females
• Prior treatment with CAT-3888 (BL22), moxetumomab pasudotox, or any pseudomonas-exotoxin-containing compound
• Prior treatment with any anticancer biologic therapy within 2 weeks prior to starting study drug, including but not limited to therapeutic monoclonal antibodies or antibody-drug conjugates
• Systemic chemotherapy ≤ 2 weeks (6 weeks for nitrosoureas) and radiation therapy ≤ 3 weeks prior to starting study drug
• Clinically significant ophthalmologic findings (evidence of retinal damage or injury) during the screening
• Presence of a second invasive malignancy
• Uncontrolled pulmonary infection, presence of pulmonary edema
• Serum albumin < 2 gram per deciliter (g/dL). Albumin infusions for correction of hypoalbuminemia are allowed, but cannot have administered within 7 days prior to start of study drug
• Radioimmunotherapy within 2 years prior to study start of study drug
• Participants with prior history of thrombotic microangiopathy or hemolytic uremic syndrome (HUS)
• T-cell ALL or T-cell lymphoblastic lymphoma
• Participants currently receiving high-dose estrogen therapy defined as >0.625 milligram per day (mg/day) of an estrogen compound or within 2 weeks prior to starting study drug.

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Los Angeles, California, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — New York, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Seattle, Washington, United States
• Research Site — Parkville, Australia
• Research Site — Westmead, Australia
• Research Site — Edmonton, Alberta, Canada
• Research Site — Lyon, France
• Research Site — Paris, France
• Research Site — Vandœuvre-lès-Nancy, France
• Research Site — Rome, Italy
• Research Site — Rotterdam, Netherlands
• Research Site — Barcelona, Spain
• Research Site — Madrid, Spain
• Research Site — Bristol, United Kingdom

Full record on ClinicalTrials.gov

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