Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate)
Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma · Source last updated 2019-10-15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
After each cycle or monthly (whichever is less frequent), 30 days post last dose. Treatment duration was at a median of 13 weeks (range 11-20) for high-risk patients and 10 weeks (range 9-12) for low-risk patients.
What was measured
Adverse events (AE) graded as either 3 or 4 and determined to be at least possibly related to study treatment will be collected in patients Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen to assess the safety and toxicity profile of the addition of rituximab, subsitution of adriamycin for doxil and lower dose of methotrexate. AEs will be assessed as follows at the following time points: At the end of each cycle or monthly whichever is less frequent and 30 days post last dose of study treatment for a maximum of 3 cycles for regimen A and 4 cycles for regimen B and up to 12 months.
In general AEs will be assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v 3.0). In general adverse events (AEs) will be graded according to the following:
Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Analysis population: All patients that receive at least one dose of study drug are evaluable for this outcome measure
Groups in this outcome
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
Patients are stratified between high risk and low risk disease status.
High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated.
Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen
Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
Low Risk - Treatment With 3 Cycles of R-CODOX-M
Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A).
Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen
Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
20
Low Risk - Treatment With 3 Cycles of R-CODOX-M
5
Reported measurements
Anemia : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
13
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
3
Not reported
Not reported
Not reported
Not reported
Anemia : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
1
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Neutropenia : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
5
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
2
Not reported
Not reported
Not reported
Not reported
Neutropenia : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
6
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
2
Not reported
Not reported
Not reported
Not reported
Thrombocytopenia : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
1
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
1
Not reported
Not reported
Not reported
Not reported
Thrombocytopenia : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
13
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
2
Not reported
Not reported
Not reported
Not reported
Mucositis : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
7
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
2
Not reported
Not reported
Not reported
Not reported
Mucositis : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
3
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Infection : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
8
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
1
Not reported
Not reported
Not reported
Not reported
Infection : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Elevated Transaminases : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
6
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
2
Not reported
Not reported
Not reported
Not reported
Elevated Transaminases : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Fever (Neutropenic) : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
4
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
3
Not reported
Not reported
Not reported
Not reported
Fever (Neutropenic) : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Low Phosphate : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
5
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
1
Not reported
Not reported
Not reported
Not reported
Low Phosphate : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Sodium Abnormalities : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
4
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
2
Not reported
Not reported
Not reported
Not reported
Sodium Abnormalities : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Hyperglycemia : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
1
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
3
Not reported
Not reported
Not reported
Not reported
Hyperglycemia : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
5
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Hypoalbuminemia : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
4
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Hypoalbuminemia : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Hypokalemia : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
1
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
2
Not reported
Not reported
Not reported
Not reported
Hypokalemia : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Cardiac : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
3
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Cardiac : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Diarrhea : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
2
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Diarrhea : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Elevated Creatinine : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
2
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Elevated Creatinine : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Nausea/Vomiting : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
1
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Nausea/Vomiting : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Low Blood Pressure : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
1
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Low Blood Pressure : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Rash : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
1
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Rash : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Edema : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
1
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Edema : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Low Magnesium : Grade 3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
1
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Low Magnesium : Grade 4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
0
Not reported
Not reported
Not reported
Not reported
Low Risk - Treatment With 3 Cycles of R-CODOX-M
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
3
title
Anemia : Grade 3
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Anemia : Grade 4
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
2
title
Neutropenia : Grade 3
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
2
title
Neutropenia : Grade 4
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
title
Thrombocytopenia : Grade 3
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
2
title
Thrombocytopenia : Grade 4
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
2
title
Mucositis : Grade 3
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
0
title
Mucositis : Grade 4
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
1
title
Infection : Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Infection : Grade 4
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
2
title
Elevated Transaminases : Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Elevated Transaminases : Grade 4
denoms
counts
group Id
OG000
value
20
group Id
OG001
value
5
units
Participants
description
Adverse events (AE) graded as either 3 or 4 and determined to be at least possibly related to study treatment will be collected in patients Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen to assess the safety and toxicity profile of the addition of rituximab, subsitution of adriamycin for doxil and lower dose of methotrexate. AEs will be assessed as follows at the following time points: At the end of each cycle or monthly whichever is less frequent and 30 days post last dose of study treatment for a maximum of 3 cycles for regimen A and 4 cycles for regimen B and up to 12 months.
In general AEs will be assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v 3.0). In general adverse events (AEs) will be graded according to the following:
Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
groups
description
Patients are stratified between high risk and low risk disease status.
High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated.
Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen
Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
id
OG000
title
High Risk - Treated With Alternating R-CODOX-M/R-IVAC
description
Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A).
Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen
Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
id
OG001
title
Low Risk - Treatment With 3 Cycles of R-CODOX-M
param Type
NUMBER
population Description
All patients that receive at least one dose of study drug are evaluable for this outcome measure
reporting Status
POSTED
time Frame
After each cycle or monthly (whichever is less frequent), 30 days post last dose. Treatment duration was at a median of 13 weeks (range 11-20) for high-risk patients and 10 weeks (range 9-12) for low-risk patients.
title
Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate)
Triangle