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TERMINATED
NCT03856216
PHASE2

Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

The goal of this phase II clinical study is to learn about the safety of inotuzumab ozogamicin when given with fludarabine, with or without bendamustine, melphalan, and rituximab before and after a stem cell transplant. Researchers also want to learn if inotuzumab ozogamicin when given after a stem cell transplant can help control leukemia and lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab attaches to CD22-positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving chemotherapy before a bone marrow or peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor attack the body's normal cells (called graft-versus-host disease). Giving tacrolimus and filgrastim before or after the transplant may stop this from happening. Fludarabine, bendamustine, melphalan, and rituximab are commonly given before stem cell transplants. Giving inotuzumab ozogamicin with chemotherapy may work better in treating patients with leukemia or lymphoma undergoing stem cell transplantation.

Official title: Addition of Inotuzumab Ozogamicin Pre- and Post-Allogeneic Transplantation

Key Details

Gender

All

Age Range

12 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2019-10-28

Completion Date

2025-10-13

Last Updated

2026-04-15

Healthy Volunteers

No

Interventions

PROCEDURE

Allogeneic Bone Marrow Transplantation

Given IV

DRUG

Bendamustine

Given IV

BIOLOGICAL

Filgrastim-sndz

Given IV

DRUG

Fludarabine

Given IV

BIOLOGICAL

Inotuzumab Ozogamicin

Given IV

DRUG

Melphalan

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Given IV

BIOLOGICAL

Rituximab

Given IV

DRUG

Tacrolimus

Given IV and PO

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States