Hyper-CVAD chemoimmunotherapy with or without rituximab for treatment of b cell acute lymphoblastic leukemia

A clinical trial on the comparative effect of hyper-CVAD chemotherapy with or without Rituximab on complete remission of b cell acute lymphoblastic leukemia

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140519017756N35

Enrollment

104

Registered

2018-01-31

Start date

2018-01-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

B cell acute lymphoblastic leukemia. Acute lymphoblastic leukemia, in remission

Interventions

Intervention 1: Intervention group (with rituximab): Intravenous infusion during two hours of cyclophosphamide ampoule of 300 mg per surface of the body every 12 hours on days 1 to 3, vincristine ampo

Treatment - Drugs

Intervention group (with rituximab): Intravenous infusion during two hours of cyclophosphamide ampoule of 300 mg per surface of the body every 12 hours on days 1 to 3, vincristine ampoule of 2 mg per

Control group (without rituximab): Intravenous infusion during two hours of cyclophosphamide ampoule of 300 mg per surface of the body every 12 hours on days 1 to 3, vincristine ampoule of 2 mg per bo

Eligibility

Sex/Gender

All

Age

14 Years to 50 Years

Inclusion criteria

Inclusion criteria: Informed written consent for participation B cell acute lymphoblastic leukemia Positive CD20 receptor Initial admission for chemotherapy Age between 14 and 50

Exclusion criteria

Exclusion criteria: Karnofsky Performance Scale equal or less than 60% Echocardiographic Cardiac Ejection Fraction equal or less than 4 Serum Bilirubin equal or more than 4 Age equal or less than 14 years old and more than 50 years old Pregnancy

Design outcomes

Primary

Measure	Time frame
Bone marrow cellularity. Timepoint: Every two weeks. Method of measurement: Bone marrow aspiration and bone marrow biopsy.;Platelet count. Timepoint: Every two weeks. Method of measurement: Complete count of blood cells.;Number of neutrophils. Timepoint: Every two weeks. Method of measurement: Complete count of blood cells.	—

Secondary

Measure	Time frame
Hepatomegaly. Timepoint: Every three weeks. Method of measurement: Physical examination.;Splenomegaly. Timepoint: Every three weeks. Method of measurement: Physical examination.;The number of white blood cells. Timepoint: Every two weeks. Method of measurement: Complete count of blood cells.;Hemoglobin level. Timepoint: Every two weeks. Method of measurement: Complete count of blood cells.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mahsa Hoseini

Mashhad University of Medical Sciences

Dr.mahsahoseini@gmail.com+98 51 3841 1538

Outcome results

None listed

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