Actively Recruiting
Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2025-12-18
276
Participants Needed
1
Research Sites
852 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I/II trial studies the side effects and best dose of inotuzumab ozogamicin and to see how well it works when given together with combination chemotherapy in treating patients with acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called N-acetyl-gamma-calicheamicin dimethyl hydrazide (CalichDMH). Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers CalichDMH to kill them. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy 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 together with combination chemotherapy may be a better treatment for acute lymphoblastic leukemia.
CONDITIONS
Official Title
Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 60 years or older with previously untreated pre-B ALL, Philadelphia chromosome positive or negative
- Patients aged 18 to under 60 years unfit for intensive therapy with previously untreated pre-B ALL
- Unfit patients defined by ECOG performance status 2 or higher, severe cardiac or pulmonary disorder, low creatinine clearance, or liver disorder
- Patients aged 60 years and older unfit for intensive chemotherapy with one or more comorbidities and performance status of 1 or higher
- Zubrod performance status between 0 and 3
- Adequate liver function with bilirubin less than 1.95 mg/dL and SGPT or SGOT less than 3 times upper limit of normal, or adjusted limits if due to tumor
- Adequate renal function with creatinine clearance 50 mL/min/1.73 m2 or higher, or adjusted limits if due to tumor
- Written informed consent provided
- Patients in first remission
- Patients of any age with refractory-relapsed ALL or related high-grade B-cell lymphomas with marrow involvement
You will not qualify if you...
- Newly diagnosed Burkitt's leukemia or lymphoma, T-cell ALL, or lymphoblastic lymphoma
- Active heart disease with NYHA class greater than 3
- Cardiac ejection fraction below 40%
- Active hepatitis infection
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Elias Jabbour, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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