Description:
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.
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.
Terminated
Phase 2
NCT ID: NCT02227108
ORG ID: CD-ON-CAT-8015-1036
B-Cell Pediatric ALL
Drug | Synonyms | Arms |
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The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in
pediatric subjects with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma
This is a global, multicenter, open-label, single-arm Phase 2 study to evaluate the efficacy
and safety of moxetumomab pasudotox monotherapy in pediatric subjects with relapsed or
refractory B-cell ALL or B-cell lymphoblastic lymphoma. Subjects will be enrolled at sites
in North America, Europe, and Australia. This is an approximate 35-month study.
Name | Type | Description | Interventions |
---|---|---|---|
1 | Experimental | Moxetumomab pasudotox |
Inclusion Criteria -
1. Between the ages of 6 months and < 18 years of age
2. Must have histologically proven B-cell ALL or B-cell lymphoblastic lymphoma with
marrow involvement.
3. All subjects (both ALL and subjects with lymphoblastic lymphoma) must have M2 or M3
bone marrow classification.
4. Disease status:
1. Subjects must have relapsed or refractory disease
2. In the event of relapse after prior allogeneic HSCT, subjects 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.
3. Must have resolution of the acute toxic effects to Grade 2 from prior
chemotherapy before entry, in the opinion of the investigator
5. Subjects with the following central nervous system (CNS 1 or 2) status are eligible
only in the absence of neurologic symptoms
6. Female subjects of childbearing potential and post-pubertal male subjects must use an
approved method of contraception for the study
Exclusion Criteria
1. Concurrent enrollment in another clinical study for cancer treatment, unless the
subject is in the follow-up period from a previous study.
2. Isolated testicular or CNS ALL
3. Subjects with mixed-lineage leukemia (MLL) gene rearrangement
4. Inadequate Hepatic function
5. Inadequate Renal function
6. Radiologically-detected CNS lymphoma
7. Subjects with clear laboratory or clinical evidence of disseminated intravascular
coagulation (DIC
8. Hyperleukocytosis or rapidly progressive disease that would compromise ability to
complete study therapy
9. QTcF interval greater than or equal to a Grade 2, confirmed by 2 additional
seperate 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.
10. Pregnant or breast-feeding females
11. Prior treatment with CAT-3888 (BL22), moxetumomab pasudotox, or any
pseudomonas-exotoxin-containing compound
12. 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
13. Systemic chemotherapy 2 weeks (6 weeks for nitrosoureas) and radiation therapy 3
weeks prior to starting study drug
14. Clinically significant ophthalmologic findings (evidence of retinal damage or injury)
during the screening
15. Presence of a second invasive malignancy.
16. Uncontrolled pulmonary infection, presence of pulmonary edema
17. Serum albumin < 2 g/dL. Albumin infusions for correction of hypoalbuminemia are
allowed, but cannot have administered within 7 days prior to start of study drug.
18. Radioimmunotherapy within 2 years prior to study start of study drug.
19. Subject with prior history of thrombotic microangiopathy or HUS.
20. T-cell ALL or T-cell lymphoblastic lymphoma
21. Subjects currently receiving high-dose estrogen therapy defined as >0.625mg/day of an
estrogen compound or within 2 weeks prior to starting study drug.
Minimum Eligible Age: 6 Months
Maximum Eligible Age: 18 Years
Eligible Gender: Both
Composite complete response (CRc) rate in efficacy evaluable subjects, where CRc is defined as complete response (CR) or CR with incomplete count recovery
Measure for the number and pecentage of subjects with serious adverse events (SAE's)
Assessment of pharmacokinetics (AUC, Cmax, clearance, half-life) of moxetumomab pasudotox
Efficacy of moxetumomab pasudotox measured by: Minimal residual disease (MRD)-negative CRc rate
Efficacy of moxetumomab pasudotox measured by the proportion of evaluable subjects who become eligible to receive a stem cell transplant (SCT)
Efficacy of moxetumomab pasudotox measured by the proportion of subjects who are neutropenic at study entry and who experience hematologic activity
Efficacy of moxetumomab pasudotox measured by the duration of complete response (DOCR), duration of overall response (DOR), progression-free survival (PFS), and overall survival (OS)
Number and percentage of subjects who develop detectable anti-drug antibodies and neutralizing antibodies
Efficacy of moxetumomab pasudotox measured by: overall response rate (ORR)
Efficacy of moxetumomab pasudotox measured by time to transplant for evaluable subjects who become eligible to receive a SCT
number and percentage of subjects with adverse events (AEs).
pediatric cancer,pediatric acute lymphoblastic leukemia, lymphoblastic lymphoma, B-cell leukemia, ALL, moxetumomab pasudotox, CD22