Actively Recruiting
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
Led by Leland Metheny · Updated on 2025-06-05
44
Participants Needed
7
Research Sites
508 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects. The Phase II portion of this study is to see what side effects are seen with medication after transplant. Inotuzumab ozogamicin is a combination of an antibody and chemotherapy which has been shown to have significant activity against relapsed/refractory acute lymphocytic leukemia (ALL). Inotuzumab ozogamicin is considered experimental in this study.
CONDITIONS
Official Title
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CD22-positive acute lymphoblastic leukemia
- Underwent allogeneic hematopoietic stem cell transplantation from any donor source for ALL
- Between 40 and 100 days after allogeneic transplantation
- Received first dose of inotuzumab ozogamicin at or before day 100 post-transplant
- Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of transplant, or in second or third complete remission at transplant, or treated with reduced intensity or non-myeloablative conditioning, or lymphoid blast crisis of CML, or relapsed/refractory to at least one chemotherapy line, or Philadelphia-like ALL
- Evidence of donor chimerism after transplant (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 greater than 1,000/µL for 3 days
- Platelet count greater than 50,000/µL for 7 days without transfusions
- Ability to follow study visit schedule and protocol requirements
- Ability and willingness to sign informed consent
You will not qualify if you...
- Clinical evidence of disease progression before enrollment
- Persistent treatment toxicities grade 2 or higher (except alopecia, neuropathy)
- Creatinine clearance less than 30 ml/min
- Bilirubin greater than twice the institutional upper limit
- AST or ALT greater than twice the institutional upper limit
- Grade III or IV graft-versus-host disease (GVHD)
- Active acute or chronic liver GVHD
- History of veno-occlusive disease
- Use of concomitant TKI or sirolimus
- Second active malignancy except non-melanoma skin cancer or carcinoma in situ
- Uncontrolled illnesses including active infections, 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 with positive PCR
- Participation in another investigational drug study within 21 days or 5 half-lives prior
- Known allergies or intolerance to study medications or related compounds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
L
Leland Metheny, MD
CONTACT
R
Ron Sobecks, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here