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

Phase 1

Recruiting

• Conditions: B cell acute lymphoblastic leukemia.; Acute lymphoblastic leukemia, in remission; C91.01

• Registration Number: IRCT20140519017756N35
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 104

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.