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

NCT02227108 | Terminated Phase 2 Results DMC

• 1 other identifier: CD-ON-CAT-8015-1036
• Study Type: interventional
• Target: 37
• Locations: 8 countries
• Sites: 21

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 lymphoblastic lymphoma.

Conditions

B-Cell Pediatric ALL

Keywords

pediatric cancer,pediatric acute lymphoblastic leukemia, lymphoblastic lymphoma, B-cell leukemia, ALL, moxetumomab pasudotox, CD22

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Composite Complete Response (CRc)

  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.

  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

Secondary Outcomes (23)

• Percentage of Participants With Minimal Residual Disease (MRD)-Negative CRc Rate

  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

• Overall Response Rate (ORR)

  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

• Time to Overall Response

  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

• Best Overall Response (BOR)

  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

• Bone Marrow Blast Percentage Change

  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

Study Arms (1)

Moxetumomab Pasudotox 40 mcg/kg

EXPERIMENTAL

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.

Drug: Moxetumomab Pasudotox

Interventions

Moxetumomab Pasudotox DRUG

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.

Also known as: CAT-8015

Moxetumomab Pasudotox 40 mcg/kg

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (21)

Research Site

Phoenix, Arizona, United States

Location

Research Site

Los Angeles, California, United States

Location

Research Site

Chicago, Illinois, United States

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Bethesda, Maryland, United States

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Kansas City, Missouri, United States

Location

Research Site

New York, New York, United States

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Research Site

Durham, North Carolina, United States

Location

Research Site

Columbus, Ohio, United States

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Research Site

Philadelphia, Pennsylvania, United States

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Research Site

Seattle, Washington, United States

Location

Research Site

Parkville, Australia

Location

Research Site

Westmead, Australia

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Edmonton, Alberta, Canada

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Research Site

Lyon, France

Location

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Paris, France

Location

Research Site

Vandœuvre-lès-Nancy, France

Location

Research Site

Rome, Italy

Location

Research Site

Rotterdam, Netherlands

Location

Research Site

Barcelona, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Bristol, United Kingdom

Location

Related Publications (1)

• Mussai 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 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, B-Cell

Interventions

immunotoxin HA22

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

The study was terminated prior to a planned interim analysis based on lack of required efficacy in the first 32 participants enrolled.

Results Point of Contact

• Title: AstraZeneca Clinical Study Information Center
• Organization: MedImmune LLC

information.center@astrazenea.com

1-877-240-9479

Study Officials

• Medimmune Inc. Medimmune Inc.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 27, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 6, 2017
• Results First Posted: February 27, 2017

Record last verified: 2017-03

Locations

NL (1); CA (1); US (10); ES (2); GB (1); IT (1); AU (2); FR (3)