Trial Outcomes & Findings for Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma (NCT NCT00126191)
NCT ID: NCT00126191
Last Updated: 2013-05-23
Results Overview
Complete Response (CR): Disappearance of all measurable or evaluable disease confirmed. Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable. Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment.
TERMINATED
PHASE2
10 participants
3 years
2013-05-23
Participant Flow
This BL protocl was IRB approved 01/18/05, activated 7/18/05. Participants were identified either in the outpatient clinic at DFCI or while admitted to our partner inpatient hospital, Brigham \& Women's Hospital. The study was closed to accrual 6/2/08 due to slow accrual.
Participants with previous chemotherapy or radiation, uncontrolled infection, concomitant malignancy (some exclusions), serious comorbid disease, pregnancy, and HIV+ were excluded. Subjects stratified according to risk: Single focus disease \<10cm and normal LGH=low risk, all others high risk.
Participant milestones
| Measure |
Low Risk
Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
|
High Risk
Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
8
|
|
Overall Study
COMPLETED
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Low Risk
Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
|
High Risk
Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma
Baseline characteristics by cohort
| Measure |
Low Risk
n=2 Participants
Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
|
High Risk
n=8 Participants
Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
8 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 yearsComplete Response (CR): Disappearance of all measurable or evaluable disease confirmed. Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable. Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment.
Outcome measures
| Measure |
Low Risk
n=2 Participants
Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
|
High Risk
n=8 Participants
Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
|
|---|---|---|
|
Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt
|
2 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Until disease progression up to 120 monthsPopulation: One low-risk participant was lost to follow-up after 48 months of disease free survival.
Participants are followed after completion of protocol therapy until disease progression to determine disease free survival.
Outcome measures
| Measure |
Low Risk
n=1 Participants
Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
|
High Risk
n=8 Participants
Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
|
|---|---|---|
|
Disease Free Survival
|
84 Months
Interval 84.0 to 84.0
|
52 Months
Interval 2.0 to 83.0
|
Adverse Events
Low Risk
High Risk
Serious adverse events
| Measure |
Low Risk
n=2 participants at risk
Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
|
High Risk
n=8 participants at risk
Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
|
|---|---|---|
|
Metabolism and nutrition disorders
Bilirubin
|
50.0%
1/2 • Number of events 1
Grade 4 hematologic toxicities were not considered to be serious adverse events in this Burkitts Lymphoma study. Hospitalization without accompanying SAE did not constitute SAE for this study.
|
12.5%
1/8 • Number of events 1
Grade 4 hematologic toxicities were not considered to be serious adverse events in this Burkitts Lymphoma study. Hospitalization without accompanying SAE did not constitute SAE for this study.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1
Grade 4 hematologic toxicities were not considered to be serious adverse events in this Burkitts Lymphoma study. Hospitalization without accompanying SAE did not constitute SAE for this study.
|
12.5%
1/8 • Number of events 1
Grade 4 hematologic toxicities were not considered to be serious adverse events in this Burkitts Lymphoma study. Hospitalization without accompanying SAE did not constitute SAE for this study.
|
|
Endocrine disorders
Hyperuricemia
|
50.0%
1/2 • Number of events 1
Grade 4 hematologic toxicities were not considered to be serious adverse events in this Burkitts Lymphoma study. Hospitalization without accompanying SAE did not constitute SAE for this study.
|
12.5%
1/8 • Number of events 1
Grade 4 hematologic toxicities were not considered to be serious adverse events in this Burkitts Lymphoma study. Hospitalization without accompanying SAE did not constitute SAE for this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place