Trial Outcomes & Findings for Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma (NCT NCT00392990)

Last Updated: 2019-10-15

Results Overview

Response Rate is defined as combined number of patients with Complete Remission (CR) Complete Remission undetermined (Cru) and Partial Remission (PR) for patients with Burkitt's and Burkitt-like Lymphoma/Leukemia. Response will be measured by CT scans following treatment completion and assessed using Response Criteria for Non-Hodgkin's Lymphoma where: CR=complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms. CRu=same as above but allowing for 75% decrease in lymph node masses and indeterminate or normal bone marrow. PR=50% decrease in SPD of the six largest dominant nodes or nodal masses with no increase in size or other nodes, liver, spleen and no new sites of disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

After two cycles of treatment and at completion of treatment (4 cycles for high risk and 3 cycles for low risk) up to approximately 20 weeks.

Results posted on

2019-10-15

Participant Flow

The study opened for accrual on October 4, 2006 with the first patient enrolling and starting treatment on February 6, 2007 and an accrual goal of up to 25 patients. The study was closed permanently on April 26, 2011 to further accrual with 25 patients enrolled on the study.

Patients were stratified as either high-risk or low-risk. Low Risk= patients with normal Lactic acid dehydrogenase (LDH) level, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, Ann Arbor stage as I or II and no tumor mass over 10 cm in greatest diameter. High Risk = All other patients

Participant milestones

Participant milestones
Measure	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)	High Risk - Treatment With Alternating R-CODOX-M/R-IVAC Cycles 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)
Treatment on Study STARTED	20	5
Treatment on Study COMPLETED	17	4
Treatment on Study NOT COMPLETED	3	1
Follow up for 2 Years STARTED	20	5
Follow up for 2 Years COMPLETED	16	5
Follow up for 2 Years NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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)	High Risk - Treatment With Alternating R-CODOX-M/R-IVAC Cycles 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)
Treatment on Study Adverse Event	3	1
Follow up for 2 Years Death	4	0

Baseline Characteristics

Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles n=20 Participants 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	Low Risk - Treatment With 3 Cycles of R-CODOX-M n=5 Participants 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) 4 doses)	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	4 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	4 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	5 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	5 Participants n=7 Participants	25 Participants n=5 Participants
Human Immunodeficiency Virus (HIV) Status Positive	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Human Immunodeficiency Virus (HIV) Status Negative	17 Participants n=5 Participants	4 Participants n=7 Participants	21 Participants n=5 Participants
Lactate dehydrogenase (LDH) Level Within Normal Range	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Lactate dehydrogenase (LDH) Level Elevated	15 Participants n=5 Participants	2 Participants n=7 Participants	17 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0	8 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 1	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 2	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Bulky disease Yes	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Bulky disease No	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Ann Arbor Stage Stage I	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ann Arbor Stage Stage II	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ann Arbor Stage Stage III	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ann Arbor Stage Stage IV	15 Participants n=5 Participants	0 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: After two cycles of treatment and at completion of treatment (4 cycles for high risk and 3 cycles for low risk) up to approximately 20 weeks.

Population: One patient was determined not to be evaluable for response as he did not complete 2 cycles that were required per protocol to be evaluable for this outcome measure

Outcome measures

Outcome measures
Measure	High Risk - Treated With Alternating R-CODOX-M/R-IVAC n=20 Participants 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 n=4 Participants 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)
Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen ORR after two cycles of treatment	100 percentage of patients	100 percentage of patients
Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen ORR at completion of treatment	100 percentage of patients	100 percentage of patients

SECONDARY outcome

Timeframe: At 2 years from treatment initiation Median follow up 34 months (range 15-45)

Population: Evaluable patients for this outcome measure and were reported on together and in stratified group: high-risk and low-risk

Overall Survival (OS) of patients with Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen. OS is defined from the first dose of study drug to the time of death for any reason.

Outcome measures

Outcome measures
Measure	High Risk - Treated With Alternating R-CODOX-M/R-IVAC n=20 Participants 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 n=4 Participants 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)
Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen	81 percentage of patients alive	100 percentage of patients alive

SECONDARY outcome

Timeframe: 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.

Population: All patients that receive at least one dose of study drug are evaluable for this outcome measure

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

Outcome measures

Outcome measures
Measure	High Risk - Treated With Alternating R-CODOX-M/R-IVAC n=20 Participants 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 n=5 Participants 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)
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) Anemia : Grade 3	13 participants	3 participants
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) Anemia : Grade 4	1 participants	0 participants
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) Neutropenia : Grade 3	5 participants	2 participants
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) Neutropenia : Grade 4	6 participants	2 participants
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) Thrombocytopenia : Grade 3	1 participants	1 participants
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) Thrombocytopenia : Grade 4	13 participants	2 participants
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) Mucositis : Grade 3	7 participants	2 participants
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) Mucositis : Grade 4	3 participants	0 participants
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) Infection : Grade 3	8 participants	1 participants
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) Infection : Grade 4	0 participants	0 participants
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) Elevated Transaminases : Grade 3	6 participants	2 participants
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) Elevated Transaminases : Grade 4	0 participants	0 participants
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) Fever (Neutropenic) : Grade 3	4 participants	3 participants
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) Fever (Neutropenic) : Grade 4	0 participants	0 participants
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) Low Phosphate : Grade 3	5 participants	1 participants
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) Low Phosphate : Grade 4	0 participants	0 participants
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) Sodium Abnormalities : Grade 3	4 participants	2 participants
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) Sodium Abnormalities : Grade 4	0 participants	0 participants
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) Hyperglycemia : Grade 3	1 participants	3 participants
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) Hyperglycemia : Grade 4	5 participants	0 participants
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) Hypoalbuminemia : Grade 3	4 participants	0 participants
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) Hypoalbuminemia : Grade 4	0 participants	0 participants
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) Hypokalemia : Grade 3	1 participants	2 participants
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) Hypokalemia : Grade 4	0 participants	0 participants
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) Cardiac : Grade 3	3 participants	0 participants
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) Cardiac : Grade 4	0 participants	0 participants
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) Diarrhea : Grade 3	2 participants	0 participants
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) Diarrhea : Grade 4	0 participants	0 participants
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) Elevated Creatinine : Grade 3	2 participants	0 participants
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) Elevated Creatinine : Grade 4	0 participants	0 participants
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) Nausea/Vomiting : Grade 3	1 participants	0 participants
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) Nausea/Vomiting : Grade 4	0 participants	0 participants
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) Low Blood Pressure : Grade 3	1 participants	0 participants
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) Low Blood Pressure : Grade 4	0 participants	0 participants
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) Rash : Grade 3	1 participants	0 participants
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) Rash : Grade 4	0 participants	0 participants
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) Edema : Grade 3	1 participants	0 participants
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) Edema : Grade 4	0 participants	0 participants
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) Low Magnesium : Grade 3	1 participants	0 participants
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) Low Magnesium : Grade 4	0 participants	0 participants

SECONDARY outcome

Timeframe: At 2 years from treatment initiation. Median follow up 34 months (range 15-45)

Population: Evaluable patients for this outcome measure and were reported on together and in stratified group: high-risk and low-risk

Progression Free Survival (PFS) will be defined from the first dose of study drug to the first documentation of progressive disease or death for any reason. Patients that are lost to follow-up before progression will be censored at the point of last documentation of not experiencing the event.

Outcome measures

Outcome measures
Measure	High Risk - Treated With Alternating R-CODOX-M/R-IVAC n=20 Participants 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 n=4 Participants 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)
Progression Free Survival (PFS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen	76 percentage of patients progression free	100 percentage of patients progression free

Adverse Events

High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles

Serious events: 20 serious events

Other events: 20 other events

Deaths: 4 deaths

Low Risk - Treatment With 3 Cycles of R-CODOX-M

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles n=20 participants at risk 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 n=5 participants at risk 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)
Blood and lymphatic system disorders myelodysplastic syndrome	5.0% 1/20 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	0.00% 0/5 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
Cardiac disorders Cardiac dysfunction	5.0% 1/20 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	0.00% 0/5 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
Cardiac disorders Pleuritic chest pain	5.0% 1/20 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	0.00% 0/5 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
Gastrointestinal disorders Mucositis	5.0% 1/20 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	0.00% 0/5 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
Gastrointestinal disorders GI bleed	5.0% 1/20 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	0.00% 0/5 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
General disorders Fever	5.0% 1/20 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	0.00% 0/5 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
General disorders Cerebritis	5.0% 1/20 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	0.00% 0/5 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
Infections and infestations Febrile neutropnia	25.0% 5/20 • Number of events 7 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	20.0% 1/5 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
Infections and infestations Infection	10.0% 2/20 • Number of events 2 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	0.00% 0/5 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
Infections and infestations Bloodinfection	5.0% 1/20 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	0.00% 0/5 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
Metabolism and nutrition disorders Pancytopenia	15.0% 3/20 • Number of events 3 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	20.0% 1/5 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
Nervous system disorders Neuro symptoms - Seizure	5.0% 1/20 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	0.00% 0/5 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
Renal and urinary disorders Renal failuretumor lysis syndrome	5.0% 1/20 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	0.00% 0/5 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.
Vascular disorders Hematoma	0.00% 0/20 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.	20.0% 1/5 • Number of events 1 • Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. 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.

Other adverse events

Additional Information

Leo Gordon, MD

Northwestern University

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place