Clinical trial · Interventional
Study in Pediatrics With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma
A Phase 2, Multicenter, Single-arm Study of Moxetumomab Pasudotox in Pediatric Subjects With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell Origin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated prior to a planned interim analysis based on lack of required efficacy in the first 32 participants enrolled.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-Cell Pediatric ALL | Childhood B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moxetumomab Pasudotox | Drug | Moxetumomab Pasudotox | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Moxetumomab Pasudotox 40 mcg/kg
- description
- Participants received 6 doses of moxetumomab pasudotox 40 microgram per kilogram (mcg/kg) intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
- interventionNames
- Drug: Moxetumomab Pasudotox
Primary outcomes (1)
- measure
- Percentage of Participants With Composite Complete Response (CRc)
- timeFrame
- Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year
- description
- The CRc is defined as achieving complete response (CR), or CR with incomplete count recovery \[CRi\]) in participants with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts. The efficacy assessments were evaluated as per investigator assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria - 1. Between the ages of greater or equal to (≥) 6 months and less than (\<) 18 years of age 2. Must have histologically proven B-cell acute lymphoblastic leukemia (ALL) or B-cell lymphoblastic lymphoma with marrow involvement 3. All participants (both ALL and participants with lymphoblastic lymphoma) must have M2 or M3 bone marrow classification 4. 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 5. Participants with the following central nervous system (CNS) 1 or 2 status are eligible only in the absence of neurologic symptoms 6. Female participants of childbearing potential and post-pubertal male participants 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. Participants with mixed-lineage leukemia (MLL) gene rearrangement 4. Inadequate Hepatic function 5. Inadequate Renal function 6. Radiologically-detected CNS lymphoma 7. Participants 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. 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. 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 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 18. Radioimmunotherapy within 2 years prior to study start of study drug 19. Participants with prior history of thrombotic microangiopathy or hemolytic uremic syndrome (HUS) 20. T-cell ALL or T-cell lymphoblastic lymphoma 21. 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.
References
Publications (1)
- BACKGROUNDMussai F, Campana D, Bhojwani D, Stetler-Stevenson M, Steinberg SM, Wayne AS, Pastan I. Cytotoxicity of the anti-CD22 immunotoxin HA22 (CAT-8015) against paediatric acute lymphoblastic leukaemia. Br J Haematol. 2010 Aug;150(3):352-8. doi: 10.1111/j.1365-2141.2010.08251.x. Epub 2010 Jun 7. PMID 20528877