Trial Outcomes & Findings for 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 Refractory Acute Lymphoblastic Leukemia (NCT NCT02199184)
NCT ID: NCT02199184
Last Updated: 2024-06-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Up to 8 years
Results posted on
2024-06-11
Participant Flow
Participant milestones
| Measure |
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
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
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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 Refractory Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
n=14 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 yearsComplete 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.
Outcome measures
| Measure |
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
n=14 Participants
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
|
|---|---|
|
Participants With a Response
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 8 yearsTime from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
n=14 Participants
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
|
|---|---|
|
Overall Survival Time
|
15.1 Months
Interval 1.8 to 95.3
|
SECONDARY outcome
Timeframe: Up to 8 yearsTime from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
n=14 Participants
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
|
|---|---|
|
Event-free Survival
|
3.3 Months
Interval 0.6 to 67.0
|
SECONDARY outcome
Timeframe: Up to 8 yearsResponse date to loss of response or last follow up.
Outcome measures
| Measure |
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
n=14 Participants
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
|
|---|---|
|
Complete Response Duration
|
10.0 Months
Interval 1.2 to 66.4
|
Adverse Events
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
n=14 participants at risk
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
|
|---|---|
|
Infections and infestations
Catheter Related Infection
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Infections and infestations
Septic Shock
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Infections and infestations
Upper Respiratory Infection
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
Other adverse events
| Measure |
Treatment (DA-EPOCH and Ofatumumab or Rituximab)
n=14 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
mucositis
|
14.3%
2/14 • Number of events 2 • Up to 8 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
2/14 • Number of events 2 • Up to 8 years.
|
|
Blood and lymphatic system disorders
anemia
|
14.3%
2/14 • Number of events 2 • Up to 8 years.
|
|
Gastrointestinal disorders
anorexia
|
14.3%
2/14 • Number of events 2 • Up to 8 years.
|
|
General disorders
Back pain
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Investigations
Bilirubin increase
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Injury, poisoning and procedural complications
Fall (Bone Pain)
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Gastrointestinal disorders
constipation
|
14.3%
2/14 • Number of events 2 • Up to 8 years.
|
|
Investigations
Creatinine increase
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Gastrointestinal disorders
diarrhea
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Reproductive system and breast disorders
dyspnea
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
General disorders
Edema (legs)
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
General disorders
Edema, limbs
|
14.3%
2/14 • Number of events 2 • Up to 8 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
General disorders
Fever
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Reproductive system and breast disorders
Genital Edema
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Nervous system disorders
headache
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Gastrointestinal disorders
hemorrhoid
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
14.3%
2/14 • Number of events 2 • Up to 8 years.
|
|
Metabolism and nutrition disorders
hypernatremia
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Gastrointestinal disorders
nausea
|
14.3%
2/14 • Number of events 2 • Up to 8 years.
|
|
Nervous system disorders
neuropathy
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Investigations
Neutrophil count decrease
|
14.3%
2/14 • Number of events 2 • Up to 8 years.
|
|
Investigations
Platelet count decrease
|
28.6%
4/14 • Number of events 4 • Up to 8 years.
|
|
Skin and subcutaneous tissue disorders
rash
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Up to 8 years.
|
|
Blood and lymphatic system disorders
White blood cell count decrease
|
21.4%
3/14 • Number of events 3 • Up to 8 years.
|
Additional Information
Elias Joseph Jabbour
The University of Texas MD Andeerson Cancer Center
Phone: 713-792-4764
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place