Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-02-10 @ 1:33 PM
Study NCT ID:
NCT02338050
Status:
TERMINATED
Last Update Posted:
2015-09-16
First Post:
2015-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Moxetumomab Pasudotox (CAT-8015, HA22) in Children With B-lineage Acute Lymphoblastic Leukemia and Minimal Residual Disease Prior to Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor:
Center for International Blood and Marrow Transplant Research
Organization:
Study Overview
Official Title:
A Phase II Study of the Anti-CD22 Recombinant Immunotoxin Moxetumomab Pasudotox (CAT-8015, HA22) in Children With B-lineage Acute Lymphoblastic Leukemia and Minimal Residual Disease Prior to Allogeneic Hematopoietic Stem Cell Transplantation
Status:
TERMINATED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II, open-label, nonrandomized, prospective study to evaluate the activity, safety, and feasibility of administration of moxetumomab pasudotox in the pre-allogeneic hematopoietic cell transplantation (HCT) setting to patients with B-lineage Acute Lymphoblastic Leukemia (ALL) who are in a morphologic complete remission and have pre-transplant minimal residual disease (MRD) \> 0.01% (detected by flow cytometry). The primary objective of this study is to determine if treatment with moxetumomab pasudotox in the MRD positive setting is able to lead to MRD negativity (\< 0.01% by flow cytometry) or at least a 1-log10 reduction in MRD prior to allogeneic HCT.
Detailed Description:
This is a Phase 2 study designed to assess safety, feasibility and clinical activity of pre-HCT moxetumomab pasudotox for patients with ALL in morphologic CR but with MRD. It is hypothesized that subjects in a morphologic complete remission with proven minimal residual disease (MRD) after chemotherapy for ALL planned for allogeneic HCT who receive a course of moxetumomab pasudotox prior to the start of conditioning will show a marked reduction or elimination of detectable MRD after moxetumomab pasudotox treatment without adverse impact on the feasibility or safety of allogeneic HCT.
The primary objective of this study is to determine if treatment with moxetumomab pasudotox in the MRD positive setting is able to lead to MRD negativity (\< 0.01% by flow cytometry) or at least a 1-log10 reduction in MRD prior to allogeneic HCT.
Secondary objectives to be studied include: toxicity profile (including safety and feasibility of administration in the pre-HCT setting and ability to proceed to transplant, incidence of capillary leak syndrome, hemolytic uremic syndrome and other post-HCT toxicities), comparison of quantitative MRD assessments, progression-free survival, overall survival, pharmacokinetic profiles, immunogenicity to moxetumomab pasudotox, transplant-related mortality, acute and chronic graft-versus-host disease (GVHD), and relapse.
The primary objective of this study is to determine if treatment with moxetumomab pasudotox in the MRD positive setting is able to lead to MRD negativity (\< 0.01% by flow cytometry) or at least a 1-log10 reduction in MRD prior to allogeneic HCT.
Secondary objectives to be studied include: toxicity profile (including safety and feasibility of administration in the pre-HCT setting and ability to proceed to transplant, incidence of capillary leak syndrome, hemolytic uremic syndrome and other post-HCT toxicities), comparison of quantitative MRD assessments, progression-free survival, overall survival, pharmacokinetic profiles, immunogenicity to moxetumomab pasudotox, transplant-related mortality, acute and chronic graft-versus-host disease (GVHD), and relapse.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: