Immunotherapy in B-Cell Acute Lymphoblastic Leukemia.
Kara L Davis, Catherine C Yao, Jessica A O Zimmerman...
https://pubmed.ncbi.nlm.nih.gov/41671463Actively Recruiting
Phase 1
Phase 2
Age: 16Years - 75Years
All Genders
ID03104491
Inotuzumab Ozogamicin Post-Transplant Treatment for Acute Lymphocytic Leukemia Evaluating Safety and Disease-Free Survival
Led by Leland Metheny · Updated on 2025-06-05
44
Participants Needed
7
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating inotuzumab ozogamicin, an experimental combination of an antibody and chemotherapy, for patients with CD22-positive acute lymphocytic leukemia (ALL) who have undergone allogeneic stem cell transplantation and are at high risk of relapse. This study includes two phases: Phase I focuses on determining safe dosing levels after transplant, while Phase II aims to monitor side effects and assess the treatment's efficacy in preventing disease relapse. In Phase I, participants receive escalating doses of inotuzumab ozogamicin intravenously, with dose adjustments ranging from 0.1 to 0.6 mg/m2 based on tolerability, for up to 4 cycles. Phase II follows with treatment at the recommended Phase II dose of 0.3 mg/m2 every 28 days for up to 4 cycles. Treatment continues until disease relapse, unacceptable side effects, or death. The study monitors safety, tolerability, and pharmacokinetics throughout. Participants will undergo regular clinical and laboratory assessments to track side effects, disease status, and survival outcomes up to one year after treatment initiation. Key measurements include disease-free survival, relapse rates, non-relapse mortality, and overall survival. Safety evaluations focus on myeloid toxicity, graft failure, and liver complications. Participants must adhere to visit schedules and provide informed consent. The entire study spans several months with close monitoring during and after treatment cycles.
CONDITIONS
Brief Title
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
Who Can Participate
Age: 16Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
- Underwent allogeneic hematopoietic stem cell transplantation for acute lymphocytic leukemia
- Between 40 and 100 days after allogeneic transplantation
- Have minimal residual disease within 45 days of transplant or are in second or third complete remission at transplant
- Treated with reduced intensity or non-myeloablative conditioning regimens
- Lymphoid blast crisis of chronic myeloid leukemia
- Relapsed or refractory to at least one line of chemotherapy
- Philadelphia-like acute lymphoblastic leukemia
- Evidence of donor chimerism after transplantation (Phase I) or greater than 80% donor chimerism (Phase II)
- ECOG performance status less than 2 (Phase I) or less than 1 (Phase II)
- Absolute neutrophil count over 1,000/µL for 3 days
- Platelet count over 50,000/µL for 7 days without transfusion
- Able to adhere to study visit schedule and protocol
- Willing and able to provide informed consent
You will not qualify if you...
- Clinical evidence of disease progression before enrollment
- Persistent prior treatment toxicities grade 2 or higher (except alopecia, neuropathy)
- Inadequate organ function (creatinine clearance less than 30 ml/min, bilirubin over 2 times normal, AST or ALT over 2 times normal)
- Graft-versus-host disease grade III or IV
- Active acute or chronic liver graft-versus-host disease
- History of veno-occlusive disease
- Use of concomitant tyrosine kinase inhibitors or sirolimus
- Second active malignancy except non-melanoma skin cancer or carcinoma in situ
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Pregnant or breastfeeding women
- Evidence of myelodysplasia or cytogenetic abnormalities indicating myelodysplasia
- Active hepatitis B or C infection confirmed by positive PCR
- Participation in another investigational drug study within 21 days
- Known allergies or intolerance to study medications or similar compounds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 4 cycles of 28 days each
Participants receive up to 4 cycles of inotuzumab ozogamicin administered intravenously every 28 days until relapse, unacceptable toxicity, or death, whichever occurs first.
Up to 4 treatment visits every 28 days
Trial Site Locations
Total: 7 locations
1
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68106
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Active, Not Recruiting
5
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Actively Recruiting
6
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
7
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
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Research Team
L
Leland Metheny, MD
R
Ron Sobecks, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
A multicenter study of posttransplantation low-dose inotuzumab ozogamicin to prevent relapse of acute lymphoblastic leukemia.
Leland L Metheny, Ronald Sobecks, Christina Cho...
https://pubmed.ncbi.nlm.nih.gov/38170741