Dose Adjusted EPOCH Regimen in Combination With Ofatumumab or Rituximab in Treating Patients With Newly Diagnosed or Relapsed or Refractory Burkitt Lymphoma or Relapsed or Refracto

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Complete Remission: Normalization of the peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 109/L or above and platelet count of 100 x 10\^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.

Source null

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secondary · POSTED

Time from date of treatment start until date of death due to any cause or last Follow-up.

Source null

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secondary · POSTED

Time from date of treatment start until the date of first objective documentation of disease-relapse.

Source null

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secondary · POSTED

Response date to loss of response or last follow up.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-high-grade-b-cell-lymphoma-with-myc-bcl2-and-bcl6-rearrangements
nct id: NCT02199184
trial label: Dose Adjusted EPOCH Regimen in Combination With Ofatumumab or Rituximab in Treating Patients With Newly Diagnosed or Relapsed or Refractory Burkitt Lymphoma or Relapsed or Refracto
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-high-grade-b-cell-lymphoma-with-myc-bcl2-and-bcl6-rearrangements
nct id
NCT02199184
outcome key
om-0000
source section id
NCT02199184-om-0000
source outcome index
0
endpoint
Participants With a Response
endpoint definition
Complete Remission: Normalization of the peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 109/L or above and platelet count of 100 x 10\^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.
time origin
Up to 8 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-high-grade-b-cell-lymphoma-with-myc-bcl2-and-bcl6-rearrangements
nct id
NCT02199184
outcome key
om-0001
source section id
NCT02199184-om-0001
source outcome index
1
endpoint
Overall Survival Time
endpoint definition
Time from date of treatment start until date of death due to any cause or last Follow-up.
time origin
Up to 8 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-high-grade-b-cell-lymphoma-with-myc-bcl2-and-bcl6-rearrangements
nct id
NCT02199184
outcome key
om-0002
source section id
NCT02199184-om-0002
source outcome index
2
endpoint
Event-free Survival
endpoint definition
Time from date of treatment start until the date of first objective documentation of disease-relapse.
time origin
Up to 8 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-high-grade-b-cell-lymphoma-with-myc-bcl2-and-bcl6-rearrangements
nct id
NCT02199184
outcome key
om-0003
source section id
NCT02199184-om-0003
source outcome index
3
endpoint
Complete Response Duration
endpoint definition
Response date to loss of response or last follow up.
time origin
Up to 8 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-high-grade-b-cell-lymphoma-with-myc-bcl2-and-bcl6-rearrangements
nct id
NCT02199184
outcome key
om-0000
arm key
OG000
arm label
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
regimen
Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02199184-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-high-grade-b-cell-lymphoma-with-myc-bcl2-and-bcl6-rearrangements
nct id
NCT02199184
outcome key
om-0001
arm key
OG000
arm label
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
regimen
Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02199184-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-high-grade-b-cell-lymphoma-with-myc-bcl2-and-bcl6-rearrangements
nct id
NCT02199184
outcome key
om-0002
arm key
OG000
arm label
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
regimen
Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02199184-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-high-grade-b-cell-lymphoma-with-myc-bcl2-and-bcl6-rearrangements
nct id
NCT02199184
outcome key
om-0003
arm key
OG000
arm label
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
regimen
Patients receive DA-EPOCH regimen comprising doxorubicin hydrochloride IV, vincristine sulfate IV, and etoposide IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 1-2 hours on day 5; and prednisone PO BID on days 1-5. Patients also receive ofatumumab IV over 2 hours on days 1, 2, and 11 of cycle 1; on days 1 and 8 of cycles 2 and 4; and on days 1 and 11 of cycle 3 for a total of 9 injections. Patients may receive rituximab instead of ofatumumab if their insurance provider does not cover the cost of ofatumumab. Patients receive rituximab IV over 2 hours on days 1 and 11 of cycles 1 and 3 and on days 2 and 8 of cycles 2 and 4. Treatment repeats every 21-28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ofatumumab: Given IV Prednisone: Given PO Rituximab: Given IV Vincristine Sulfate: Given IV
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02199184-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-high-grade-b-cell-lymphoma-with-myc-bcl2-and-bcl6-rearrangements
nct id
NCT02199184
harm key
EG000
source section id
NCT02199184-ae
event group key
EG000
event group label
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
serious affected
4
serious at risk
14
other affected
14
other at risk
14
frequency threshold
5
collection period
Up to 8 years.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice