Inotuzumab Ozogamicin + Chemotherapy for Leukemia or Lymphoma
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications. However, certain medications like rituximab, ibrutinib, and venetoclax are allowed shortly before starting the trial treatment. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Bendamustine in treating leukemia or lymphoma?
Is the combination of Inotuzumab Ozogamicin and Chemotherapy safe for treating leukemia or lymphoma?
Bendamustine, a component of the treatment, has been studied for safety in various blood cancers like chronic lymphocytic leukemia and non-Hodgkin's lymphoma. It is generally considered safe, with known side effects that can often be managed by adjusting the dose. Long-term safety data have been collected to ensure its safe use in patients.12346
What makes the drug combination of Inotuzumab Ozogamicin, Bendamustine, and Melphalan unique for treating leukemia or lymphoma?
This drug combination is unique because it combines Inotuzumab Ozogamicin, a targeted therapy that delivers a toxic agent directly to cancer cells, with Bendamustine and Melphalan, which are chemotherapeutic agents that work through different mechanisms to kill cancer cells. This multi-faceted approach may offer a novel treatment option for patients with leukemia or lymphoma, especially those who have not responded to standard therapies.13789
Research Team
Issa F. Khouri
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults aged 18-35 with CD22+ lymphoid malignancies, including B-ALL, who are eligible for a reduced-intensity stem cell transplant. Participants must have proper liver and kidney function, not be pregnant or breastfeeding, and have a compatible donor. Excluded are those with high peripheral blast counts, certain heart conditions, HIV, active hepatitis B or C, recent chemotherapy or radiation treatments (with some exceptions), prior inotuzumab ozogamicin treatment within 3 weeks of study entry.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Transplant Treatment
Patients receive inotuzumab ozogamicin and chemotherapy before stem cell transplantation
Stem Cell Transplantation
Patients undergo stem cell transplantation and receive supportive care
Post-Transplant Treatment
Patients receive inotuzumab ozogamicin and supportive care post-transplant
Maintenance
Patients receive maintenance therapy with inotuzumab ozogamicin
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bendamustine
- Inotuzumab Ozogamicin
- Melphalan
Bendamustine is already approved in United States, European Union, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
- Multiple myeloma
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator