Status:
TERMINATED
Study in Pediatrics With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma
Lead Sponsor:
MedImmune LLC
Conditions:
B-Cell Pediatric ALL
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief Summary
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 lymph...
Detailed Description
This is a global, multicenter, open-label, single-arm Phase 2 study to evaluate the efficacy and safety of moxetumomab pasudotox monotherapy in pediatric participants with relapsed or refractory B-cel...
Eligibility Criteria
Inclusion
- Inclusion Criteria -
- Between the ages of greater or equal to (≥) 6 months and less than (\<) 18 years of age
- Must have histologically proven B-cell acute lymphoblastic leukemia (ALL) or B-cell lymphoblastic lymphoma with marrow involvement
- All participants (both ALL and participants with lymphoblastic lymphoma) must have M2 or M3 bone marrow classification
- Disease status: a) Participants must have relapsed or refractory disease b) In the event of relapse after prior allogeneic hematopoietic stem cell transplant (HSCT), participants must be at least 3 months post-transplant and have no evidence of active graft-vs-host disease, and must have been off immunosuppression for at least 4 weeks, c) Must have resolution of the acute toxic effects to less than or equal to (≤) Grade 2 from prior chemotherapy before entry, in the opinion of the investigator
- Participants with the following central nervous system (CNS) 1 or 2 status are eligible only in the absence of neurologic symptoms
- Female participants of childbearing potential and post-pubertal male participants must use an approved method of contraception for the study.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT02227108
Start Date
August 1 2014
End Date
November 1 2015
Last Update
April 6 2017
Active Locations (21)
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1
Research Site
Phoenix, Arizona, United States
2
Research Site
Los Angeles, California, United States
3
Research Site
Chicago, Illinois, United States
4
Research Site
Bethesda, Maryland, United States