A Phase I study of Inotuzumab Ozogamicin as a single agent for pediatric patients in Japan with relapsed/refractory CD22-positive Acute Lymphoblastic Leukemia
- Conditions
- Relapsed or refractory CD22-positive ALL Relapsed or refractory CD22-positive lymphoblastic lymphoma and bone marrow involvement
- Registration Number
- JPRN-UMIN000033351
- Lead Sponsor
- ational Cancer Center Hospital Nagoya Medical Center Osaka City General Hospital Kyushu Cancer Center Hyogo Prefectural Kobe Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
1. Isolated extramedullary relapse (testicular or CNS) 2. Burkitt's or mixed phenotype acute leukemia (WHO 2008 criteria) 3. Active central nervous system leukemia. Prophylactic intrathecal medication is not excluded. 4. Having undergone prior chemotherapy at enrollment excluding therapy to reduce the circulating lymphoblast count or palliation: steroids, hydroxycarbamide, or vincristine 5. Prior administration of monoclonal antibodies within 4 weeks of enrollment 6. Prior rituximab treatment at enrollment 7. Prior allogeneic HSCT or other anti-CD22 immunotherapy <=4 months before enrollment 8. Having completed immunosuppression therapy in GvHD prior to enrollment. With >= Grade 2 acute GvHD, or extensive chronic GvHD at enrollment 9. Systemic vasculitides, or primary or secondary immunodeficiency 10.Active HbsAg B or HCV C infection or seropositivity for HIV 11. Major surgery within <=4 weeks before enrollment 12. Unstable or severe uncontrolled medical condition 13. Concurrent active malignancy excluding non-melanoma skin cancer that has been definitely treated with radiation or surgery, calculated cervical high grade squamous intraepithelial lesion (CIN2, CIN3), or localized prostate cancer. Those with previous malignancies in disease free for >=2 years 14. <45% cardiac function (left ventricular ejection fraction), or class >=3 (Modified Ross Heart Failure Classification) 15. Active heart disease 16. Myocardial infarction <=6 months before enrollment 17. History of chronic liver disease 18. History of hepatic veno-occlusive disease or sinusoidal obstruction syndrome 19. Live vaccine administration <=6 weeks before enrollment 20. Evidence of serious active infection 21. History of severe allergic or anaphylactic reaction to any humanized monoclonal antibodies 22. Participation in other studies 23. History of Inotuzumab ozogamicin administration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of first cycle dose limiting toxicities (DLTs) of inotuzumab ozogamicin
- Secondary Outcome Measures
Name Time Method 1) PK profile of inotuzumab ozogamicin 2) Safety profile, including VOD/SOS 3) Complete remission rate (CR/CRi ) 4) Minimal residual disease (MRD) status in patients achieving a CR/CRi 5) Overall survival (OS)