Role of Bortezomib and Rituximab in adult and adolescent patients newly diagnosed with B Cell Acute Lymphoblastic Leukemia(A Type of Blood Cancer)
Phase 2
Completed
- Conditions
- Health Condition 1: null- Adult Patients diagnosed with CD 20 positive Philadelphia negative Precursor B Cell Acute Lymphoblastic Leukemia
- Registration Number
- CTRI/2017/04/008393
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
Inclusion Criteria
Newly diagnosed CD20 positive Philadelphia negative Precursor B-cell ALL
Age >14 years
Performance status (ECOG) <4
Adequate liver function tests (Bilirubin <2 XULN , SGOT/PT <5 times ULN ) and renal function tests (creatinine <2XULN- unless due to leukemia)
Adequate cardiac function- LVEF- >45%
Exclusion Criteria
Active replication of Hepatitis B virus/Hepatitis C virus
Not able to sign informed consent
Inability to comply with therapy or planned follow up
Coexisting major illnesses or organ dysfunction which will not allow administration of intensive chemotherapy
History of hypersensitivity to boron based compounds
Active uncontrolled infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients achieving MRD negative bone marrow post inductionTimepoint: 2 years
- Secondary Outcome Measures
Name Time Method Percentage of patients with peripheral blood MRD 1% on day 8 <br/ ><br>Percentage of patients achieving complete response rates <br/ ><br>2-year event free survival <br/ ><br>2-year overall survival <br/ ><br>Incidence of grade ¾ neuropathy <br/ ><br>Incidence of grade ¾ infectious complications <br/ ><br>Timepoint: 2 years