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

• Status: Recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Antilymphocyte Serum; Antineoplastic Agents, Immunological; Bendamustine Hydrochloride; Fludarabine; Immunoglobulins; Inotuzumab Ozogamicin; Lenograstim; Mechlorethamine; Melphalan; Methotrexate; Nitrogen Mustard Compounds; Rituximab; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• Young adults (age 18-35) with ALL will be included only if they are not eligible for myeloablative transplants.

• CD22+ lymphoid malignancies including B acute lymphoblastic leukemia (B-ALL).

• Eligible to receive a reduced-intensity allogeneic hematopoietic stem cell transplantation (alloSCT).

• Donor: HLA compatible related or matched unrelated donor (HLA-A, B, C, DRB1).

• Performance status of 0 to 2.

• Creatinine less than or equal to 1.6 mg/dL (at time of study entry).

• Bilirubin less than 1.6 mg/dL (at time of study entry).

• Serum glutamate pyruvate transaminase (SGPT) < 2 x upper limit of normal (ULN) (at time of study entry).

• Ejection fraction >= 40% (at time of study entry).

• Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 40% (at time of study entry).

• Negative beta human chorionic gonadotropin (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.

Exclusion Criteria:

• Human immunodeficiency virus (HIV) positive.

• Philadelphia chromosome (Ph)-positive ALL.

• 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. Exception: ibrutinib and venetoclax are allowed to within 3 days.

• Prior inotuzumab ozogamicin within 3 weeks of study entry.

• Peripheral blast count of greater than 10 K/microL.

• Corrected QT using Fridericia's formula (QTcF) interval > 470 ms.