Diffuse Large B Cell LymphomaEarly Phase 1DA-EPOCH-RNCT01760226
Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies
A Early Phase 1 study testing DA-EPOCH-R for DLBCL, PTLD, AND PMBCL, Methotrexate and Etoposide in people with Diffuse Large B Cell Lymphoma and Post Transplant Lymphoproliferative Disorder, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD). Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Post Transplant Lymphoproliferative Disorder, Primary Mediastinal (Thymic) Large B-cell Lymphoma
- What is being tested?
- DA-EPOCH-R for DLBCL, PTLD, AND PMBCL, Methotrexate and Etoposide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient with newly diagnosed, histologically confirmed, diffuse large B-cell lymphoma, or primary mediastinal B-cell lymphoma; or patient has post-transplant lymphoproliferative disorder regardless of when diagnosed.
Who cannot join
- Patient has received previous chemotherapy or radiation therapy in the three months prior to therapy, except for empiric initial intrathecal administration at diagnosis
- Patient who has received any prior anthracyclines.
- Patient with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction <28%) NOT due to mediastinal mass.
- Patient with severe renal disease (i.e. creatinine greater than 3 times normal for age; creatinine clearance less than 50 ml/min/1.73m2).
- Patient with severe hepatic disease (direct bilirubin greater than 3 mg/dl or AST greater than 500 IU/L).
- Patient with a Karnofsky performance score <50% or Lansky score <50%.
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- Patient has been documented HIV positive and is unwilling/unable to stop antiretroviral therapy
- Female patient who is pregnant or breastfeeding.
- Patient is of reproductive potential and is not willing to use an acceptable method of birth control
- Patient has group classification A at diagnosis (completely resected stage I or completely resected stage II abdominal lesions)
- Patient has group classification B stage I or II disease with normal LDH level AND tumor mass less than 7 cm
- Patient has primary CNS lymphoma (lymphoma limited to the craniospinal axis without systemic involvement)
- Patient has Burkitt lymphoma or leukemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Dose Adjusted EPOCH-R in the Treatment of Childhood Mature B Cell Malignancies
The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD).
In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs.
Read more
Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children.
The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
Read the detailed description
The subject will need to have a variety of tests, exams, or procedures to find out if s/he can be on the study.
The subject will also require placement of a catheter that stays in the vein for safe administration of chemotherapy drugs.
During the study...
If all of the tests that have been done show that s/he can participate and s/he chooses to participate, treatment cycles will begin.
A cycle equals three weeks. The subject will have a minimum of 6 cycles of treatment, possibly 8. The cancer drugs s/he will receive are etoposide, vincristine, doxorubicin, cyclophosphamide, prednisone, and rituximab with each cycle. The amount of the drugs will be determined by the subject's weight at first, and some of the drugs will be adjusted up or down for later cycles.
Rituximab will be given on Day 1 prior to continuous infusion drugs.
After 4 cycles, the subject will have imaging scans again to see how the cancer responded to treatment. If the cancer responds completely after 4 cycles, s/he will get 2 more cycles (6 cycles total). If the cancer partially responds, s/he will get 4 more cycles (8 total cycles).
If the subject has cancer in the Central Nervous System, s/he will receive a drug called methotrexate. If s/he does not have cancer in the CNS, s/he will get methotrexate to try to prevent CNS cancer.
- Conditions
- Diffuse Large B Cell Lymphoma, Post Transplant Lymphoproliferative Disorder, Primary Mediastinal (Thymic) Large B-cell Lymphoma
- Being tested
- DA-EPOCH-R for DLBCL, PTLD, AND PMBCL, Methotrexate, Etoposide, Doxorubicin, Vincristine
- Keywords
- DLBCL, Diffuse large B cell lymphoma, dose adjusted, EPOCH, Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone, Rituximab
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-EPOCH-R for DLBCL, PTLD, AND PMBCLDrug
Also called DA-EPOCH-R
Day 1: Rituximab IV
Days 1-4: After rituximab, etoposide, vincristine, and doxorubicin will be given in a vein over 96 hours as a continuous infusion.
Day 5: cyclophosphamide will be given in a vein
Days 1-5: prednisone given by mouth twice a day
G-CSF 5mcg/kg/day will be given under the skin from day 6 until ANC has improved.
MethotrexateDrug
Also called MTX
CNS negative patients with high CNS risk DLBCL will receive age based, intrathecal dosing of MTX on days 1 and 5 of cycles 3 - 6 only.
CNS positive patients will receive age based, intrathecal (within the spinal fluid) MTX twice weekly for 2 weeks past the first negative cytology with a minimum of 4 weeks treatment. Then, weekly for 6 weeks and then every 4 weeks for 6 months.
DLBCL/PTLD/PMBCL CNS prophylaxis for cycles 3-6 ONLY if:
- 2+ extranodal sites
- elevated LDH,
- MYC rearrangement OR
- bone or marrow disease.
ALL OTHERS receive IT MTX cycles 3-6.
EtoposideDrug
Also called VP-16
Etoposide will be given at 50mg/m2/day on days 1-4 of the first cycle of therapy (dose based on patient height and weight). The doses in later cycles will be adjusted up or down based on the patient's blood test results.
DoxorubicinDrug
Also called Adriamycin, hydroxydaunorubicin
Doxorubicin will be given at 10mg/m2/day on days 1-4 of the first cycle (dose based on patient height and weight). The doses in later cycles will be adjusted up or down based on the patient's blood test results.
VincristineDrug
Also called Oncovin, LCR, VCR, Vincasar Pfs
Vincristine will be given on days 1-4 of each cycle at 0.4mg/m2/day (dose based on patient height and weight).
RituximabDrug
Also called Rituxan
Rituximab (375mg/m2/dose) will only be given on Day 1 of each cycle prior to all the other chemotherapy agents. Dose is based on patient height and weight.
CyclophosphamideDrug
Also called Cytoxan, Neosar, CTX
Cyclophosphamide will be given on Day 5 of each cycle. In cycle 1, the dose will be 750 mg/m2 (based on patient height and weight), and the dose will be adjusted up or down for future cycles based on blood test results.
PrednisoneDrug
Also called Deltasone
Prednisone will be given by mouth at 60mg/m2/dose (based on height and weight) twice a day on days 1-5 of each cycle.
G-CSFDrug
Also called Neupogen, Granulocyte - Colony Stimulating Factor
G-CSF will be given at 5 mcg/kg/day during each cycle, starting on day 6, until the patient's ANC (absolute neutrophil count) is greater than 5000/mcL past nadir.
| Study group | Role | What they receive |
|---|---|---|
| DA-EPOCH-R for DLBCL, PTLD & PMBCL | Experimental | Minimum of 6 cycles (cycle=3 weeks), possibly 8. Dosages of the drugs will be determined by the subject's weight and height for cycle 1. Thereafter, the dosages of some drugs will be adjusted up or down for the next cycle, dependent on the blood tests results.
DA-EPOCH-R for 2 cycles then two more cycles of DA-EPOCH-R. If complete response (CR), then DA-EPOCH-R for more 2 cycles. If no CR, DA-EPOCH-R for 4 more cycles. Receives: Drug: DA-EPOCH-R for DLBCL, PTLD, AND PMBCL; Drug: Methotrexate; Drug: Etoposide; Drug: Doxorubicin; Drug: Vincristine; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Prednisone; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure and assess adverse events
To evaluate the safety and feasibility of dose-adjusted EPOCH-R in the treatment of use in children and young adults with mature B-cell malignancies, including, DLBCL, and PMBCL, as well as in patients with post-transplant lymphoproliferative disorder (PTLD).
Measured: 1 year
Secondary outcomes (1)
Measure and assess immune function
Blood will be taken to identify tumor and plasma biomarkers and mutations in patients with mature B-cell malignancies (DLBCL, PMBCL, and PTLD) that correlate with disease response and outcome using this novel therapeutic approach.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completion26 Aug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Carl Allen, Baylor College of Medicine
- Investigators
- Carl Allen, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760226
- Sponsor's protocol ID
- H-30759, DA-EPOCH-R
- Other IDs
- DA-EPOCH-R, 5K12CA090433-12
- Acronym
- DA-EPOCH-R
- Status last verified
- Feb 2024
- First submitted
- 17 Dec 2012
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dose Adjusted EPOCH-R in the Treatment of Childhood Mature B Cell Malignancies
- ClinicalTrials.gov ID
- NCT01760226
- Acronym / sponsor ID
- DA-EPOCH-R / H-30759, DA-EPOCH-R
- Conditions
- Diffuse Large B Cell Lymphoma, Post Transplant Lymphoproliferative Disorder, Primary Mediastinal (Thymic) Large B-cell Lymphoma
- Keywords
- DLBCL, Diffuse large B cell lymphoma, dose adjusted, EPOCH, Etoposide, Doxorubicin, Vincristine, Cyclophosphamide
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2013
- Primary completion
- 26 Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD).
In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs.
Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children.
The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.
Detailed description
The subject will need to have a variety of tests, exams, or procedures to find out if s/he can be on the study.
The subject will also require placement of a catheter that stays in the vein for safe administration of chemotherapy drugs.
During the study...
If all of the tests that have been done show that s/he can participate and s/he chooses to participate, treatment cycles will begin.
A cycle equals three weeks. The subject will have a minimum of 6 cycles of treatment, possibly 8. The cancer drugs s/he will receive are etoposide, vincristine, doxorubicin, cyclophosphamide, prednisone, and rituximab with each cycle. The amount of the drugs will be determined by the subject's weight at first, and some of the drugs will be adjusted up or down for later cycles.
Rituximab will be given on Day 1 prior to continuous infusion drugs.
After 4 cycles, the subject will have imaging scans again to see how the cancer responded to treatment. If the cancer responds completely after 4 cycles, s/he will get 2 more cycles (6 cycles total). If the cancer partially responds, s/he will get 4 more cycles (8 total cycles).
If the subject has cancer in the Central Nervous System, s/he will receive a drug called methotrexate. If s/he does not have cancer in the CNS, s/he will get methotrexate to try to prevent CNS cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DA-EPOCH-R for DLBCL, PTLD & PMBCL | Experimental | Drug: DA-EPOCH-R for DLBCL, PTLD, AND PMBCL, Drug: Methotrexate, Drug: Etoposide, Drug: Doxorubicin, Drug: Vincristine, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Prednisone, Drug: G-CSFMinimum of 6 cycles (cycle=3 weeks), possibly 8. Dosages of the drugs will be determined by the subject's weight and height for cycle 1. Thereafter, the dosages of some drugs will be adjusted up or down for the next cycle, dependent on the blood tests results. DA-EPOCH-R for 2 cycles then two more cycles of DA-EPOCH-R. If complete response (CR), then DA-EPOCH-R for more 2 cycles. If no CR, DA-EPOCH-R for 4 more cycles. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patient with newly diagnosed, histologically confirmed, diffuse large B-cell lymphoma, or primary mediastinal B-cell lymphoma; or patient has post-transplant lymphoproliferative disorder regardless of when diagnosed.
Key exclusion criteria (13 listed)
- Patient has received previous chemotherapy or radiation therapy in the three months prior to therapy, except for empiric initial intrathecal administration at diagnosis
- Patient who has received any prior anthracyclines.
- Patient with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction <28%) NOT due to mediastinal mass.
- Patient with severe renal disease (i.e. creatinine greater than 3 times normal for age; creatinine clearance less than 50 ml/min/1.73m2).
- Patient with severe hepatic disease (direct bilirubin greater than 3 mg/dl or AST greater than 500 IU/L).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-EPOCH-R for DLBCL, PTLD, AND PMBCLAlso: DA-EPOCH-RDay 1: Rituximab IV Days 1-4: After rituximab, etoposide, vincristine, and doxorubicin will be given in a vein over 96 hours as a continuous infusion. Day 5: cyclophosphamide will be given in a vein Days 1-5: prednisone given by mouth twice a day G-CSF 5mcg/kg/day will be given under the skin from day 6 until ANC has improved. | Drug | DA-EPOCH-R for DLBCL, PTLD & PMBCL |
| MethotrexateAlso: MTXCNS negative patients with high CNS risk DLBCL will receive age based, intrathecal dosing of MTX on days 1 and 5 of cycles 3 - 6 only. CNS positive patients will receive age based, intrathecal (within the spinal fluid) MTX twice weekly for 2 weeks past the first negative cytology with a minimum of 4 weeks treatment. Then, weekly for 6 weeks and then every 4 weeks for 6 months. DLBCL/PTLD/PMBCL CNS prophylaxis for cycles 3-6 ONLY if: * 2+ extranodal sites * elevated LDH, * MYC rearrangement OR * bone or marrow disease. ALL OTHERS receive IT MTX cycles 3-6. | Drug | DA-EPOCH-R for DLBCL, PTLD & PMBCL |
| EtoposideAlso: VP-16Etoposide will be given at 50mg/m2/day on days 1-4 of the first cycle of therapy (dose based on patient height and weight). The doses in later cycles will be adjusted up or down based on the patient's blood test results. | Drug | DA-EPOCH-R for DLBCL, PTLD & PMBCL |
| DoxorubicinAlso: Adriamycin, hydroxydaunorubicinDoxorubicin will be given at 10mg/m2/day on days 1-4 of the first cycle (dose based on patient height and weight). The doses in later cycles will be adjusted up or down based on the patient's blood test results. | Drug | DA-EPOCH-R for DLBCL, PTLD & PMBCL |
| VincristineAlso: Oncovin, LCR, VCR, Vincasar PfsVincristine will be given on days 1-4 of each cycle at 0.4mg/m2/day (dose based on patient height and weight). | Drug | DA-EPOCH-R for DLBCL, PTLD & PMBCL |
| RituximabAlso: RituxanRituximab (375mg/m2/dose) will only be given on Day 1 of each cycle prior to all the other chemotherapy agents. Dose is based on patient height and weight. | Drug | DA-EPOCH-R for DLBCL, PTLD & PMBCL |
| CyclophosphamideAlso: Cytoxan, Neosar, CTXCyclophosphamide will be given on Day 5 of each cycle. In cycle 1, the dose will be 750 mg/m2 (based on patient height and weight), and the dose will be adjusted up or down for future cycles based on blood test results. | Drug | DA-EPOCH-R for DLBCL, PTLD & PMBCL |
| PrednisoneAlso: DeltasonePrednisone will be given by mouth at 60mg/m2/dose (based on height and weight) twice a day on days 1-5 of each cycle. | Drug | DA-EPOCH-R for DLBCL, PTLD & PMBCL |
| G-CSFAlso: Neupogen, Granulocyte - Colony Stimulating FactorG-CSF will be given at 5 mcg/kg/day during each cycle, starting on day 6, until the patient's ANC (absolute neutrophil count) is greater than 5000/mcL past nadir. | Drug | DA-EPOCH-R for DLBCL, PTLD & PMBCL |
Primary outcome
Measure and assess adverse events
Time frame: 1 year
To evaluate the safety and feasibility of dose-adjusted EPOCH-R in the treatment of use in children and young adults with mature B-cell malignancies, including, DLBCL, and PMBCL, as well as in patients with post-transplant lymphoproliferative disorder (PTLD).
1 secondary outcome
Measure and assess immune function
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Allen, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DA-EPOCH-R for DLBCL, PTLD, AND PMBCL, Methotrexate and Etoposide in people with Diffuse Large B Cell Lymphoma and Post Transplant Lymphoproliferative Disorder, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure and assess adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.