Role of Bortezomib and Rituximab in adult and adolescent patients newly diagnosed with B Cell Acute Lymphoblastic Leukemia(A Type of Blood Cancer)

Efficacy of Bortezomib and Rituximab in newly diagnosed adolescent and adult CD20 positive Philadelphia (Ph) negative Precursor B-cell acute lymphoblastic leukemia: Phase II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/04/008393

Enrollment

Registered

2017-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Adult Patients diagnosed with CD 20 positive Philadelphia negative Precursor B Cell Acute Lymphoblastic Leukemia

Interventions

Intervention1: Bortezomib: Bortezomib (1.3 mg/ m2 weekly X4 doses )will be given along with the standard of care chemotherapy and Rituximab during induction Control Intervention1: None: Single arm pha

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed CD20 positive Philadelphia negative Precursor B-cell ALL Age >14 years Performance status (ECOG) Adequate liver function tests (Bilirubin Adequate cardiac function- LVEF- >45%

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients achieving MRD negative bone marrow post inductionTimepoint: 2 years	—

Secondary

Measure	Time frame
Percentage of patients with peripheral blood MRD 1% on day 8 Percentage of patients achieving complete response rates 2-year event free survival 2-year overall survival Incidence of grade Â¾ neuropathy Incidence of grade Â¾ infectious complications Timepoint: 2 years	—

Countries

India

Contacts

Public ContactDr Manju Sengar

Tata Memorial Hospital

manju.sengar@gmail.com02224177211

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026