Efficacy of Rituximab in children with Acute Lymphoblastic Leukemia

Assessing the efficacy of Rituximab (anti CD 20 antibody) added to standard chemotherapy versus standard chemotherapy alone in achieving lower minimal residual disease after induction phase of chemotherapy in CD 20 positive children with Acute Lymphoblastic Leukemia: A pilot study

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010897

Enrollment

Registered

2017-12-15

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: C910- Acute lymphoblastic leukemia [ALL] Health Condition 2: null- Acute Lymphoblastic Leukemias

Interventions

Intervention1: Rituximab: Rituximab added to standard treatment versus standard treatment alone Intervention2: Rituximab: Rituximab at a dose of 375 mg per meter square will be given intravenously for

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosis of B Cell Acute Lymphoblastic Leukemia 2.CD 20 expression in >20 % of blast cells 3.Willing to consent for the study

Exclusion criteria

Exclusion criteria: 1.Recieved previous treatment

Design outcomes

Primary

Measure	Time frame
1.Number of patients achieving minimal residual disease (MRD)negativity at the end of induction 2.Peripheral blood MRD in both groups on Day 8 and Day 15 3.BM aspirate MRD at the end of inductionTimepoint: 1. Day 8 of induction chemotherapy 2. Day 15 of induction chemotherapy 3. End of induction chemotherapy (Usually Day 33)	—

Secondary

Measure	Time frame
Overall survival, Event free survival, Adverse effects in both armsTimepoint: 1 year, 5 years	—

Countries

India

Contacts

Public ContactAditya Kumar Gupta

All India Institute of Medical Sciences

adivick@gmail.com7838379837

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026