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 2
Age: 18Years +
All Genders
ID06427330
Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-07-30
21
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of inotuzumab ozogamicin in patients with high-risk B cell acute lymphoblastic leukemia (B-ALL) who have undergone hematopoietic stem cell transplantation (HSCT). This Phase II trial aims to evaluate the safety of giving two low doses of inotuzumab ozogamicin after HSCT and to see if this treatment can reduce relapse rates and improve disease-free survival and overall survival. Participants receive two doses of inotuzumab ozogamicin post-transplant: the first dose at day 60 after HSCT at 0.3 mg/m2 and the second dose one month later at 0.6 mg/m2. Treatment continues until disease relapse, unacceptable side effects, or death. The study monitors hematological toxicity, secondary graft failure, and other adverse events related to the treatment. During the study, participants are evaluated for disease status and safety outcomes at one year after HSCT. Researchers measure disease-free survival as the primary outcome and also assess relapse rates, mortality not related to relapse, overall survival, and treatment side effects. The study includes regular monitoring of blood counts, donor cell chimerism, and performance status, with participation lasting through the one-year post-transplant period.
CONDITIONS
Brief Title
Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
- Underwent allogeneic or autologous hematopoietic stem cell transplantation for acute lymphoblastic leukemia
- At least 60 days after transplantation
- Have high-risk B-ALL defined by high white blood cell count at diagnosis, poor risk group per NCCN 2021 guidelines, relapsed or refractory to at least one treatment, or minimal residual disease positive before transplant
- Greater than 99% donor chimerism after allogeneic transplant
- ECOG performance status of 2 or less
- Absolute neutrophil count above 1,000/µL for 3 days and platelet count above 50,000/µL for 7 days without transfusion
- 18 years or older, any gender
- Ability and willingness to sign informed consent
You will not qualify if you...
- Evidence of disease progression before enrollment
- Persistent prior treatment toxicities grade 2 or higher (except alopecia, neuropathy)
- Inadequate organ function including severe kidney, liver, heart, or lung problems
- Grade III or IV graft-versus-host disease (GVHD) after allogeneic transplant
- Active acute or chronic liver GVHD
- History of veno-occlusive disease
- Second active cancer except certain skin or in situ cancers
- Uncontrolled illnesses like active infection, severe heart problems, or psychiatric issues limiting study compliance
- Positive active hepatitis B or C infection by PCR
- Any condition affecting full study participation, safety, or data interpretation
- Known allergies or intolerance to study drugs 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 - Approximately 1 month
Participants receive two doses of low-dose inotuzumab ozogamicin after transplantation to prevent relapse of acute lymphoblastic leukemia.
2 visits approximately 1 month apart
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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