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

Description

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.

Conditions

Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Lymphocytic Neoplasm, Lymphoma

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Study Overview

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Study Details

Study overview

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.

Addition of Inotuzumab Ozogamicin Pre- and Post-Allogeneic Transplantation

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

Condition
Acute Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

Houston

M D Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants age 12 to 70.
  • * English and non-English speaking participants are eligible.
  • * CD22+ lymphoid malignancies including B-ALL
  • * Eligible to receive a reduced-intensity alloSCT
  • * Indolent lymphoma participants who failed conventional treatment; or,
  • * Acute lymphoblastic leukemia (ALL), aggressive lymphoma, indolent lymphoma in transformation, or those who have failed ≥ three small molecule inhibitors
  • * Donor: HLA compatible related or matched unrelated donor (HLA-A, B, C, DRB1)
  • * Performance status of 0 to 2, Lansky ≥ 80 for \< 16 years and Karnofsky ≥ 80 for ≥ 16 years of age.
  • * Adequate organ function at time of study entry
  • 1. Creatinine less than or equal to 1.6 mg/dL
  • 2. Bilirubin less than 1.6 mg/dL
  • 3. SGPT \< 2 x UL
  • 4. Ejection fraction \>/= 40%
  • 5. FEV1, FVC and cDLCO \>/= 40%
  • * Negative Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
  • * Human immunodeficiency virus (HIV) positive.
  • * Prior autologous transplant less than 1 year prior to consent.
  • * Active and uncontrolled disease/infection.
  • * Unable or unwilling to sign consent.
  • * Current active hepatic or biliary disease (with exception of Gilbert's syndrome).
  • * Active hepatitis B or C.
  • * Recent chemotherapy or radiation within 3 weeks of study entry. Standard biological agents such as rituximab, TKIs such as ibrutinib, and venetoclax are allowed to be given within 3 days prior to receiving inotuzumab ozogamicin.
  • * Prior inotuzumab ozogamicin within 3 weeks of study entry.
  • * Peripheral blast count of greater than 10 K/mL.
  • * QTcF interval \> 470 ms.
  • * Participants with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.

Ages Eligible for Study

12 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

M.D. Anderson Cancer Center,

Issa F Khouri, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

2025-03-31