Actively Recruiting
Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-07-30
21
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival.
CONDITIONS
Official Title
Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia
Who Can Participate
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, relapsed or refractory to at least one treatment, or minimal residual disease positive before HSCT
- More than 99% donor chimerism after allogeneic transplantation
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Absolute neutrophil count above 1,000/µL for 3 days
- Platelet count above 50,000/µL for 7 days without transfusion
- Age 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)
- Severe organ dysfunction including renal failure with creatinine clearance below 50 ml/min, severe liver dysfunction with bilirubin or liver enzymes more than twice the upper limit of normal, or severe heart or lung disease
- Graft-versus-host disease grade III or IV
- Active acute or chronic liver graft-versus-host disease
- History of veno-occlusive disease
- Second active cancer except non-melanoma skin cancer or carcinoma in situ
- Uncontrolled infections or illnesses such as congestive heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting study compliance
- Active hepatitis B or C infection confirmed by positive PCR
- Allergy or intolerance to study drugs or similar compounds
- Any condition interfering with participation or study drug administration as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
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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