Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma
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ClinicalTrials.gov Identifier: NCT01092182 |
Recruitment Status :
Active, not recruiting
First Posted : March 24, 2010
Results First Posted : October 19, 2021
Last Update Posted : November 9, 2022
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Burkitt Lymphoma Diffuse Large B-cell Lymphoma, c-MYC Positive Plasmablastic Lymphoma |
Interventions |
Drug: EPOCH-R Drug: EPOCH-RR |
Enrollment | 194 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Low-risk Burkitt Lymphoma (BL) | High-Risk Burkitt Lymphoma (BL) | High-Risk Diffuse Large B Cell Lymphoma (DLBCL) |
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Burkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles |
Burkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles |
High-Risk Diffuse Large B Cell Lymphoma Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles |
Period Title: Overall Study | |||
Started | 15 | 98 | 81 |
Completed | 14 | 80 | 53 |
Not Completed | 1 | 18 | 28 |
Reason Not Completed | |||
Death | 0 | 5 | 3 |
participant safety | 1 | 2 | 0 |
Physician Decision | 0 | 6 | 0 |
Did not meet criteria | 0 | 0 | 25 |
Non-compliance | 0 | 3 | 0 |
Participant refused follow-up | 0 | 2 | 0 |
Arm/Group Title | Group A - Low-risk Burkitt Lymphoma (BL) | Group B - High-Risk Burkitt Lymphoma (BL) | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | Total | |
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Burkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles |
Burkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles |
Diffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles |
Total of all reporting groups | |
Overall Number of Baseline Participants | 15 | 98 | 81 | 194 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | 98 participants | 81 participants | 194 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
|
0 0.0%
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Between 18 and 65 years |
13 86.7%
|
84 85.7%
|
55 67.9%
|
152 78.4%
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>=65 years |
2 13.3%
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14 14.3%
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26 32.1%
|
42 21.6%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 15 participants | 98 participants | 81 participants | 194 participants | |
51.47 (14.85) | 46.35 (17.53) | 57.47 (14) | 51.39 (16.74) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 15 participants | 98 participants | 81 participants | 194 participants | |
Female |
4 26.7%
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20 20.4%
|
20 24.7%
|
44 22.7%
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Male |
11 73.3%
|
78 79.6%
|
61 75.3%
|
150 77.3%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 15 participants | 98 participants | 81 participants | 194 participants |
Black or African American |
2 13.3%
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16 16.3%
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6 7.4%
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24 12.4%
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White |
11 73.3%
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65 66.3%
|
66 81.5%
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142 73.2%
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Indian or Alaska Native |
1 6.7%
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0 0.0%
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0 0.0%
|
1 0.5%
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Indian or Alaska Native + White |
0 0.0%
|
1 1.0%
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0 0.0%
|
1 0.5%
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Asian |
1 6.7%
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5 5.1%
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2 2.5%
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8 4.1%
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Race Unknown/Not Reported |
0 0.0%
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11 11.2%
|
7 8.6%
|
18 9.3%
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Hispanic or Latino |
1 6.7%
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10 10.2%
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4 4.9%
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15 7.7%
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Not Hispanic or Latino |
14 93.3%
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80 81.6%
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72 88.9%
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166 85.6%
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Ethnicity Unknown/Not Reported |
0 0.0%
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8 8.2%
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5 6.2%
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13 6.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 15 participants | 98 participants | 81 participants | 194 participants |
15 | 98 | 81 | 194 | ||
Eastern Cooperative Oncology Group (ECOG)
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 15 participants | 98 participants | 81 participants | 194 participants |
0 |
11 73.3%
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39 39.8%
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26 32.1%
|
76 39.2%
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|
1 |
4 26.7%
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38 38.8%
|
37 45.7%
|
79 40.7%
|
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2 |
0 0.0%
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14 14.3%
|
9 11.1%
|
23 11.9%
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|
3 |
0 0.0%
|
4 4.1%
|
7 8.6%
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11 5.7%
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4 |
0 0.0%
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3 3.1%
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2 2.5%
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5 2.6%
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[1]
Measure Description:
ECOG Criteria: 0 - Normal activity
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Baseline Risk Stratification
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 15 participants | 98 participants | 81 participants | 194 participants |
Low Risk |
15 100.0%
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0 0.0%
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0 0.0%
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15 7.7%
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High Risk |
0 0.0%
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98 100.0%
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81 100.0%
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179 92.3%
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[1]
Measure Description: Low Risk disease High Risk disease
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International Prognostic Index Score 0-5
[1] Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 15 participants | 98 participants | 81 participants | 194 participants |
0 |
12 80.0%
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8 8.2%
|
7 8.6%
|
27 13.9%
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|
1 |
3 20.0%
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19 19.4%
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7 8.6%
|
29 14.9%
|
|
2 |
0 0.0%
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20 20.4%
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28 34.6%
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48 24.7%
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|
3 |
0 0.0%
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24 24.5%
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30 37.0%
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54 27.8%
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|
4 |
0 0.0%
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24 24.5%
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5 6.2%
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29 14.9%
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5 |
0 0.0%
|
3 3.1%
|
4 4.9%
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7 3.6%
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[1]
Measure Description: International Prognostic Index Score 0 -1 is low risk 2 is low-intermediate risk 3 is high-intermediate risk 4 - 5 is high risk
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Histology
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 15 participants | 98 participants | 81 participants | 194 participants |
High Grade B Cell Lymphoma Double-hit (HGBL DH) | NA [1] | NA [1] |
24 29.6%
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NA [2] | |
High Grade B Cell Lymphoma Not Otherwise Specified (HGBL NOS) | NA [1] | NA [1] |
12 14.8%
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NA [2] | |
Diffuse Large B-Cell Lymphoma (DLBCL) | NA [1] | NA [1] |
44 54.3%
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NA [2] | |
Plasmablastic | NA [1] | NA [1] |
1 1.2%
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NA [2] | |
[1]
This study specific measure is only applicable to Group C.
[2]
Total not calculated because data are not available (NA) in one or more arms.
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Name/Title: | Dr. Mark J. Roschewski |
Organization: | National Cancer Institute |
Phone: | 240-760-6183 |
EMail: | roschewskimj@nih.gov |
Responsible Party: | Mark Roschewski, M.D., National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT01092182 |
Other Study ID Numbers: |
100052 10-C-0052 |
First Submitted: | March 23, 2010 |
First Posted: | March 24, 2010 |
Results First Submitted: | September 29, 2021 |
Results First Posted: | October 19, 2021 |
Last Update Posted: | November 9, 2022 |