MedTrace Logo

Inotuzumab Ozogamicin and Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia

NCT03851081 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-01-28

No results posted yet for this study

Summary

This phase Ib/II trial studies side effects and best dose of inotuzumab ozogamicin and how well it works when given together with vincristine sulfate liposome in treating patients with CD22 positive (+) B-cell acute lymphoblastic leukemia that has come back or dose not respond to treatment. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22+ cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as vincristine sulfate liposome, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin and vincristine sulfate liposome together may work better in treating patients with CD22+ B-cell acute lymphoblastic leukemia compared to giving inotuzumab ozogamicin or vincristine sulfate liposome alone.

Conditions

  • Allogeneic Hematopoietic Stem Cell Transplantation Recipient
  • Blasts 5 Percent or More of Bone Marrow Nucleated Cells
  • Blasts 5 Percent or More of Peripheral Blood White Cells
  • CD22 Positive
  • Lymphoblasts 20 Percent or More of Bone Marrow Nucleated Cells
  • Lymphoblasts 20 Percent or More of Peripheral Blood White Cells
  • Recurrent B Acute Lymphoblastic Leukemia
  • Refractory B Acute Lymphoblastic Leukemia

Interventions

BIOLOGICAL

Inotuzumab Ozogamicin

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Vincristine Sulfate Liposome

Given IV

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Eunice S Wang · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2023-01-21
Completion
2024-01-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03851081 on ClinicalTrials.gov