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Alkylating agents

EPOCH-RR for Burkitt Lymphoma

Phase 2

Waitlist Available

Led By Mark J Roschewski, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of progression or death at 4 years

Awards & highlights

Study Summary

This trial is testing a new chemotherapy treatment for Burkitt lymphoma/leukemia that may be just as effective as the current standard treatment but with fewer side effects.

Eligible Conditions

Burkitt Lymphoma
Plasmablastic Lymphoma
Diffuse Large B-Cell Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval

Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval

Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval

Secondary outcome measures

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

Other outcome measures

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Side effects data

From 2023 Phase 2 trial • 194 Patients • NCT01092182

47%

White blood cell decreased

40%

Constipation

40%

Anemia

33%

Lymphocyte count decreased

33%

Neutrophil count decreased

33%

Peripheral sensory neuropathy

27%

Fatigue

27%

Alopecia

20%

Platelet count decreased

13%

Alanine aminotransferase increased

13%

Abdominal pain

13%

Blood bilirubin increased

13%

Bone pain

13%

Skin and subcutaneous tissue disorders - Other, abdominal abscess

13%

Hypophosphatemia

13%

Nervous system disorders - Other, neuropathy, upper bilateral extremities

Myalgia

Hyponatremia

Urinary tract pain

Upper respiratory infection

Generalized muscle weakness

Headache

Chest pain - cardiac

Hypokalemia

Nervous system disorders - Other, numbness in left arm

Mucositis oral

Neck pain

Catheter related infection

Febrile neutropenia

Fever

Flatulence

Gastritis

Infections and infestations - Other, clostridium difficile

Anorexia

Aspartate aminotransferase increased

Back pain

Chills

Dyspnea

Hypermagnesemia

Hypertension

Infections and infestations - Other, bacteremia

Insomnia

Nausea

Oral hemorrhage

Oral pain

Pain

Sleep apnea

Sinus bradycardia

Toothache

Nervous system disorders - Other, neuropathy

Skin and subcutaneous tissue disorders - Other, skin darkening

Skin and subcutaneous tissue disorders - Other, vitiligo

100%

80%

60%

40%

20%

Study treatment Arm

Group A - Low-risk Burkitt Lymphoma (BL)

Group B - High-Risk Burkitt Lymphoma (BL)

Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group C - DLBCL high risk armExperimental Treatment1 Intervention

Diffuse large B-cell lymphoma (DLBCL) high risk arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Group II: Group B - Burkitt lymphoma High Risk ArmExperimental Treatment1 Intervention

Burkitt lymphoma High Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Group III: Group A - Burkitt lymphoma Low Risk ArmExperimental Treatment1 Intervention

Burkitt lymphoma Low Risk Arm Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) every 21 days for 6 cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EPOCH-RR

2010

Completed Phase 2

~200

EPOCH-R

2000

Completed Phase 2

~220

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,667 Previous Clinical Trials

40,925,972 Total Patients Enrolled

138 Trials studying Burkitt Lymphoma

14,440 Patients Enrolled for Burkitt Lymphoma

Mark J Roschewski, M.D.Principal InvestigatorNational Cancer Institute (NCI)

18 Previous Clinical Trials

1,970 Total Patients Enrolled

2 Trials studying Burkitt Lymphoma

356 Patients Enrolled for Burkitt Lymphoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please outline the EPOCH-RR drug safety profile for us?

"EPOCH-RR falls into the Phase 2 category, so there is some data supporting its safety. However, since this is a Phase 2 medication, there is no evidence yet of efficacy."

Answered by AI

Which type of cancer does EPOCH-RR show the most promise in treating?

"EPOCH-RR is most often used to treat merkel cell cancer. It can also be taken as a form of intervention for leukemia, ophthalmia, prostate cancer, and sympathetic cancers."

Answered by AI

Are there any current openings for patients who want to participate in this trial?

"Unfortunately, this trial is not currently looking for new patients. It was originally posted on March 25th 2010 and last updated November 7th 2020. However, there are 1813 other trials related to burkitt lymphoma enrolling participants and 1641 EPOCH-RR trials still admitting patients."

Answered by AI

How many people are chosen to participate in this experiment?

"This trial is not currently recruiting participants at this time. The trial was initially posted on 3/25/2010 and was last edited on 11/7/2022. If you are searching for other studies, there are presently 1813 trials actively admitting patients with burkitt lymphoma and 1641 trials for EPOCH-RR actively recruiting patients."

Answered by AI

At how many different locations is this trial currently taking place?

"A few of the 31 locations where this study is running are Emory University /Winship Cancer Institute in Atlanta, Georgia, University of Illinois in Chicago, Illinois and UC San Diego Moores Cancer Center in La Jolla, California."

Answered by AI

Are there any other instances in which EPOCH-RR has been explored?

"As of now, there are 1641 active studies investigating EPOCH-RR with 360 trials currently in Phase 3. Though a few of the EPOCH-RR studies are based in Bethesda, Maryland, there are 59759 clinical trial sites around the world."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Multicenter Study of Risk-adapted Therapy with Dose-adjusted EPOCH-R in Adults with Untreated Burkitt Lymphoma

Roschewski, Mark, Kieron Dunleavy, Jeremy S. Abramson, Bayard L. Powell, Brian K. Link, Prapti Patel, Philip J. Bierman, et al.. 2020. “Multicenter Study of Risk-adapted Therapy with Dose-adjusted EPOCH-R in Adults with Untreated Burkitt Lymphoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.00303.

The Lancet HaematologyJournal

Dose-adjusted EPOCH-R (etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab) in Untreated Aggressive Diffuse Large B-cell Lymphoma with MYC Rearrangement: A Prospective, Multicentre, Single-arm Phase 2 Study

Dunleavy, Kieron, Michelle A Fanale, Jeremy S Abramson, Ariela Noy, Paolo Fabrizio Caimi, Stefania Pittaluga, Samir Parekh, et al.. 2018. “Dose-adjusted EPOCH-R (etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, and Rituximab) in Untreated Aggressive Diffuse Large B-cell Lymphoma with MYC Rearrangement: A Prospective, Multicentre, Single-arm Phase 2 Study”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(18)30177-7.

clinicaltrials.govStudy

Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma

Mark Roschewski, M.D. 2010. "Phase II Study of Dose-Adjusted EPOCH-Rituximab in Adults With Untreated Burkitt Lymphoma and c-MYC+ Diffuse Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01092182.