Clinical Trials /

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

NCT02227108

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

A Phase 2, Multicenter Study in Pediatric Subjects With Relapsed or Refractory Pediatric <span class="go-doc-concept go-doc-disease">Acute Lymphoblastic Leukemia</span> (pALL) or Lymphoblastic Lymphoma

Title

  • Brief Title: A Phase 2, Multicenter Study in Pediatric Subjects With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma
  • Official Title: 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
  • Clinical Trial IDs

    NCT ID: NCT02227108

    ORG ID: CD-ON-CAT-8015-1036

    Trial Conditions

    B-Cell Pediatric ALL

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    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

    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 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.

    Trial Arms

    Name Type Description Interventions
    1 Experimental Moxetumomab pasudotox

    Eligibility Criteria

    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

    Primary Outcome Measures

    Composite complete response (CRc) rate in efficacy evaluable subjects, where CRc is defined as complete response (CR) or CR with incomplete count recovery

    Secondary Outcome Measures

    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).

    Trial Keywords

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