A Phase 2 interventional study of EPOCH-R and EPOCH-RR in Burkitt Lymphoma, Diffuse Large B-cell Lymphoma, c-MYC Positive and Plasmablastic Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 30 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
Background:
Objectives:
Eligibility:
Design:
Background:
Objectives:
Eligibility:
Study Design:
976 studies on the registry are indexed under Burkitt Lymphoma; 159 are open to participants now.
This study's enrollment of 194 is above the median of 36 across 765 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must have one of the following histologic diagnoses:
-Patients must have Burkitt Lymphoma. Effective with Amendment J (version date: 06/24/2014), the following histologies were removed as the maximum number allowed for these sub-groups has been reached: B-cell lymphoma: unclassifiable with features intermediate between Diffuse Large B cell lymphoma and Burkitt Lymphoma ; c-MYC + Diffuse large B-cell lymphoma (DLBCL) and c-MYC+ plasmablastic lymphoma.
If questions arise related to diagnosis, please contact the National Cancer Institute (NCI) Principal Investigator, Dr. Mark Roschewski or the NCI study coordinator, A. Nicole Lucas.
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Burkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
Drug: EPOCH-RR
Burkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
Drug: EPOCH-R
Diffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
Drug: EPOCH-R
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles
Also known as: Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, Rituximab
Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 3 cycles
Also known as: Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, Rituximab
Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval
PFS is the time interval from start of treatment to documented evidence of disease progression. Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of \< 1.5 cm (\< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
Time frame: Time of progression or death at 4 years
Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval
EFS was determined from the date of enrolment in the study until the date of progression, last documentation of disease at or after the last treatment cycle, death, or last follow-up (whichever occurred first). Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of \< 1.5 cm (\< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
Time frame: At 4 years
Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval
OS was calculated from the enrolment date until date of death or last follow-up using the Kaplan Meier. Kaplan-Meier curves were constructed with an 95% confidence interval.
Time frame: At 4 years
Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2
The predictive value of early FDG-PET/CT scans on PFS was assessed after cycle 2. PFS is the time interval from start of treatment to documented evidence of disease progression, assessed by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of \< 1.5 cm (\< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
Time frame: After 2 cycles of therapy and prior to cycle 3
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Date treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C.
| Milestone | Low-risk Burkitt Lymphoma (BL) | High-Risk Burkitt Lymphoma (BL) | High-Risk Diffuse Large B Cell Lymphoma (DLBCL) |
|---|---|---|---|
| Started | 15 | 98 | 81 |
| Completed | 14 | 80 | 53 |
| Not completed | 1 | 18 | 28 |
| Withdrew: Death | 0 | 5 | 3 |
| Withdrew: Participant safety | 1 | 2 | 0 |
| Withdrew: Physician decision | 0 | 6 | 0 |
| Withdrew: Did not meet criteria | 0 | 0 | 25 |
| Withdrew: Non-compliance | 0 | 3 | 0 |
| Withdrew: Participant refused follow-up | 0 | 2 | 0 |
PFS is the time interval from start of treatment to documented evidence of disease progression. Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of \< 1.5 cm (\< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
| percentage of participants | Group A - Low-risk Burkitt Lymphoma (BL) | Group B - High-Risk Burkitt Lymphoma (BL) | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) |
|---|---|---|---|
| Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval | 100 (1 to 100) | 82.1 (72.7 to 88.5) | 71.0 (56.5 to 81.4) |
EFS was determined from the date of enrolment in the study until the date of progression, last documentation of disease at or after the last treatment cycle, death, or last follow-up (whichever occurred first). Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of \< 1.5 cm (\< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
| percentage of participants | Group A - Low-risk Burkitt Lymphoma (BL) | Group B - High-Risk Burkitt Lymphoma (BL) | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) |
|---|---|---|---|
| Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval | 100 (1 to 100) | 82.1 (72.7 to 88.5) | 71.0 (58.5 to 81.4) |
OS was calculated from the enrolment date until date of death or last follow-up using the Kaplan Meier. Kaplan-Meier curves were constructed with an 95% confidence interval.
| percentage of participants | Group A - Low-risk Burkitt Lymphoma (BL) | Group B - High-Risk Burkitt Lymphoma (BL) | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) |
|---|---|---|---|
| Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval | 100 (1 to 100) | 84.9 (75.8 to 90.8) | 76.7 (62.6 to 86.1) |
The predictive value of early FDG-PET/CT scans on PFS was assessed after cycle 2. PFS is the time interval from start of treatment to documented evidence of disease progression, assessed by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of \< 1.5 cm (\< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval.
| percentage of participants | Group A - Low-risk Burkitt Lymphoma (BL) | Group B - High-Risk Burkitt Lymphoma (BL) | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) |
|---|---|---|---|
| Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2 | 100 (1 to 100) | 90.0 (77.7 to 95.7) | 78.7 (60.5 to 89.2) |
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
| Participants | Group A - Low-risk Burkitt Lymphoma (BL) | Group B - High-Risk Burkitt Lymphoma (BL) | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) |
|---|---|---|---|
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 13 | 87 | 72 |
Collected over Date treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A - Low-risk Burkitt Lymphoma (BL) | 0/15 (0%) | 3/15 (20%) | 13/15 (86.7%) |
| Group B - High-Risk Burkitt Lymphoma (BL) | 16/98 (16.3%) | 58/98 (59.2%) | 88/98 (89.8%) |
| Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) | 3/81 (3.7%) | 33/81 (40.7%) | 71/81 (87.7%) |
| Event | Group A - Low-risk Burkitt Lymphoma (BL) | Group B - High-Risk Burkitt Lymphoma (BL) | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) |
|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 0/15 | 27/98 | 11/81 |
| White blood cell decreasedInvestigations | 0/15 | 15/98 | 5/81 |
| AnemiaBlood and lymphatic system disorders | 1/15 | 12/98 | 4/81 |
| Neutrophil count decreasedInvestigations | 1/15 | 11/98 | 5/81 |
| Death NOSGeneral disorders | 0/15 | 10/98 | 9/81 |
| Mucositis oralGastrointestinal disorders | 0/15 | 8/98 | 0/81 |
| Lymphocyte count decreasedInvestigations | 1/15 | 7/98 | 3/81 |
| Catheter related infectionInfections and infestations | 1/15 | 0/98 | 0/81 |
| HyponatremiaMetabolism and nutrition disorders | 1/15 | 3/98 | 2/81 |
| Infections and infestations - Other, clostridium difficileInfections and infestations | 1/15 | 0/98 | 0/81 |
| Event | Group A - Low-risk Burkitt Lymphoma (BL) | Group B - High-Risk Burkitt Lymphoma (BL) | Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL) |
|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 6/15 | 62/98 | 53/81 |
| White blood cell decreasedInvestigations | 7/15 | 47/98 | 52/81 |
| Lymphocyte count decreasedInvestigations | 5/15 | 54/98 | 49/81 |
| Neutrophil count decreasedInvestigations | 5/15 | 55/98 | 49/81 |
| Platelet count decreasedInvestigations | 3/15 | 52/98 | 43/81 |
| ConstipationGastrointestinal disorders | 6/15 | 20/98 | 22/81 |
| Peripheral sensory neuropathyNervous system disorders | 5/15 | 26/98 | 22/81 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/15 | 29/98 | 22/81 |
| FatigueGeneral disorders | 4/15 | 22/98 | 22/81 |
| AlopeciaSkin and subcutaneous tissue disorders | 4/15 | 9/98 | 6/81 |
| Age, Categorical(Participants) | 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 |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 84 | 55 | 152 |
| >=65 years | 2 | 14 | 26 | 42 |
| Age, Continuous(years) | 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 |
|---|---|---|---|---|
| Mean | 51.47 ± 14.85 | 46.35 ± 17.53 | 57.47 ± 14 | 51.39 ± 16.74 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|
| Female | 4 | 20 | 20 | 44 |
| Male | 11 | 78 | 61 | 150 |
| Race/Ethnicity, Customized(Participants) | 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 |
|---|---|---|---|---|
| Black or African American | 2 | 16 | 6 | 24 |
| White | 11 | 65 | 66 | 142 |
| Indian or Alaska Native | 1 | 0 | 0 | 1 |
| Indian or Alaska Native + White | 0 | 1 | 0 | 1 |
| Asian | 1 | 5 | 2 | 8 |
| Race Unknown/Not Reported | 0 | 11 | 7 | 18 |
| Hispanic or Latino | 1 | 10 | 4 | 15 |
| Not Hispanic or Latino | 14 | 80 | 72 | 166 |
| Ethnicity Unknown/Not Reported | 0 | 8 | 5 | 13 |
| Region of Enrollment(participants) | 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 |
|---|---|---|---|---|
| United States | 15 | 98 | 81 | 194 |
| Eastern Cooperative Oncology Group (ECOG)(Participants) | 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 |
|---|---|---|---|---|
| 0 | 11 | 39 | 26 | 76 |
| 1 | 4 | 38 | 37 | 79 |
| 2 | 0 | 14 | 9 | 23 |
| 3 | 0 | 4 | 7 | 11 |
| 4 | 0 | 3 | 2 | 5 |
| Baseline Risk Stratification(Participants) | 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 |
|---|---|---|---|---|
| Low Risk | 15 | 0 | 0 | 15 |
| High Risk | 0 | 98 | 81 | 179 |
| International Prognostic Index Score 0-5(Participants) | 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 |
|---|---|---|---|---|
| 0 | 12 | 8 | 7 | 27 |
| 1 | 3 | 19 | 7 | 29 |
| 2 | 0 | 20 | 28 | 48 |
| 3 | 0 | 24 | 30 | 54 |
| 4 | 0 | 24 | 5 | 29 |
| 5 | 0 | 3 | 4 | 7 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Clinical data available during the study and indefinitely.
Access criteria: Clinical data will be made available upon request to the study principal investigator.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Etoposide
National Cancer Institute (NCI) →