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Hodgkin LymphomaPhase 2NCT03755804

Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

A Phase 2 study testing bendamustine, Etoposide and Doxorubicin in people with Hodgkin Lymphoma, run by St. Jude Children's Research Hospital at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase II study using risk and response-adapted therapy for low, intermediate and high risk classical Hodgkin lymphoma. Chemotherapy regimens will be based on risk group assignment. Read more about this study

Who is it for?
Ages Up to 25 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
bendamustine, Etoposide and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
232 participants
Where
8 sitesUnited States
Study dates
12 Dec 2018to 1 Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Histologically confirmed, previously untreated CD30+ classical HL. (Participants are still eligible if they received limited emergent RT or steroid therapy - maximum of 7 days if within the last month or as approved by PI).
  • Age ≤ 21 years at the time of diagnosis (i.e., participants are eligible until their 22nd birthday) for low-risk and intermediate-risk
  • Age ≤ 25 years at the time of diagnosis (i.e., participants are eligible until their 26th birthday) for high-risk
  • All Ann Arbor stages.
  • Low-Risk: IA, IIA (excluding patients with "E" lesions or mediastinal bulk)
  • Intermediate-Risk: IA or IIA with "E" lesions or bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph) and IB, IIIA.
Show all 16Show fewer
  • High-Risk: IIB, IIIB, IV
  • Adequate renal function based on GFR ≥ 70 ml/min/1.73m2 OR serum creatinine adjusted for age and gender as follows: Age 1 to < 2 years: maximum serum creatinine 0.6 mg/dL for males and 0.6 mg/dL for females, Age 2 to < 6 years: maximum serum creatinine 0.8 mg/dL for males and 0.8 mg/dL for females, Age 6 to < 10 years: maximum serum creatinine 1 mg/dL for males and 1 mg/dL for females, Age 10 to < 13 years: maximum serum creatinine 1.2 mg/dL for males and 1.2 mg/dL for females, Age 13 to < 16 years: maximum serum creatinine 1.5 mg/dL for males and 1.4 mg/dL for females, Age ≥16 years: maximum serum creatinine 1.7 mg/dL for males and 1.4 mg/dL for females
  • Adequate hepatic function (total bilirubin ≤ 1.5 x ULN for age, and AST/ALT ≤ 2.5 x ULN for age).
  • Adequate hematologic criteria at baseline, unless secondary to Hodgkin disease diagnosis
  • Absolute neutrophil count (ANC) ≥1000/µL
  • Platelets ≥ 75,000/µL
  • Adequate cardiac function defined as shortening fraction of ≥ 27% by echocardiogram or MUGA, unless decreased function is due to large mediastinal mass or effusion related to HL.
  • Adequate pulmonary function defined as no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 92% on room air unless secondary to a large mediastinal mass or effusion related to HL.
  • Female participant who is post-menarchal must have a negative urine or serum pregnancy test.
  • Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.

Who cannot join

  • CD30 negative HL.
  • Has received prior therapy for Hodgkin lymphoma
  • Inadequate organ function
  • High-risk participants with a history of ≥ grade 2 peripheral neuropathy or any active neurologic disease that would impede the ability to assess neurologic toxicities.
  • Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • St. Jude Affiliate Baton Rouge Clinic (Our Lady of the Lakes Regional Medical Center)

    Baton Rouge, Louisiana, 70809

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital

    Charlotte, North Carolina, 28204

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, 94304

  • St. Jude Midwest Affiliate - Peoria

    Peoria, Illinois, 61637

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074

Other trials in United States

About this study

This is a phase II study using risk and response-adapted therapy for low, intermediate and high risk classical Hodgkin lymphoma. Chemotherapy regimens will be based on risk group assignment. Low-risk and intermediate- risk patients will be treated with bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine, and prednisone (BEABOVP) chemotherapy. High-risk patients will receive Adcetris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) (AEPA) and cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC) (CAPDac) chemotherapy. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an adequate response (AR) after 2 cycles of therapy for all risk groups.

Read the detailed description

PRIMARY OBJECTIVES

  • To evaluate the efficacy (adequate response) after 2 cycles of BEABOVP (bendamustine substitution for mechlorethamine in the original Stanford V chemotherapy backbone) in low-risk and intermediate-risk patients with classical Hodgkin lymphoma (cHL).
  • To estimate the event-free survival in high-risk patients with classical Hodgkin lymphoma (cHL).

SECONDARY OBJECTIVES

  • To describe the acute hematologic and infectious toxicities of BEABOVP (bendamustine substitution for mechlorethamine in the original Stanford V chemotherapy backbone) in patients with low-risk and intermediate- risk cHL as they relate to transfusion requirements, hematopoietic growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
  • To describe the acute hematologic, neuropathic, and infectious toxicities of AEPA/CAPDac in patients with high-risk cHL as they relate to transfusion requirements, hematopoietic growth factor support, episodes of grade 3 and 4 sensory or motor neuropathy, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
  • To evaluate patterns of failure in irradiated and non-irradiated patients.
  • To estimate the EFS functions of LR and IR patients, and compare with those in previously published studies.
  • To estimate the response rate in HR patients and compare with historical and literature rates.
  • To compare response rates in LR and IR patients with historical and literature rates.
  • To compare the EFS function of HR patients with that in previously published studies.

EXPLORATORY OBJECTIVES

  • To evaluate the plasma pharmacokinetics of bendamustine along with predictors of its variability when used as part of BEABOVP regimen for pediatric cHL patients
  • To explore the patterns and dynamics of T-cell clonality in classical Hodgkin lymphoma
  • To explore the association between TARC, total metabolic tumor volume, stage, risk group and treatment response.
  • To establish next generation sequencing of ctDNA as a reliable method of non-invasively profiling tumor-associated mutations in pediatric patients with HL.
  • To determine if kinetics of ctDNA in patients with pediatric HL during treatment are predictive of outcome.
  • To obtain baseline testing by St. Jude Lifetime Study (SJLIFE) to allow for enhanced survivorship follow-up:
  • Neurologic testing
  • Neurocognitive testing
  • Quantitative brain imaging
  • Polysomnography
  • Cardiovascular testing (valvular testing, arterial elasticity, carotid-femoral pulse wave velocity, orthostatic hypotension, heart rate variability
  • Neuropathy screening
  • Changes in body mass index composition during therapy

Low-risk and Intermediate-risk: Low-risk patients will receive 2 cycles of BEABOVP and Intermediate-risk patients will receive 3 cycles of BEABOVP.

BEABOVP regimen: Patients will receive bendamustine day 1, etoposide day 15, Adriamycin® (doxorubicin) days 1 and 15, bleomycin days 8 and 22, Oncovin® (vincristine) days 8 and 22, vinblastine days 1 and 15, and prednisone two or three times per day every other day of each cycle for a total of 14 days of steroids.

High-risk patients will receive 2 cycles of AEPA and 4 cycles of CAPDac.

AEPA regimen: Patients will receive Adcedris® (brentuximab vedotin) days 1, 8 and 15, etoposide days 1 to 5, prednisone two or three times daily days 1 to 15 and Adriamycin® (doxorubicin) days 1 and 15.

CAPDac regimen: Patients will receive cyclophosphamide days 1 and 8, Adcetris® (brentuximab vedotin) days 1 and 8, prednisone two or three times daily days 1 to 15 and Dacarbazine® (DTIC) days 1 to 3.

Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy for all risk groups.

Steroids will be omitted after 2 cycles for any IR or HR patient with an AR after 2 cycles of therapy.

Being tested
bendamustine, Etoposide, Doxorubicin, Bleomycin, Vincristine
Keywords
Hodgkin Lymphoma, Pediatric Cancer, Frontline Therapy, Response Adapted Therapy, Risk Adapted Therapy
Medical subject headings
Hodgkin Disease, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bendamustineDrug

    Also called TREANDA (R)

    Given intravenously (IV)

  • EtoposideDrug

    Also called VP-16, Vepeside

    Given intravenously (IV)

  • DoxorubicinDrug

    Also called Adriamycin (R)

    Given intravenously (IV)

  • BleomycinDrug

    Also called Blenoxane (R)

    Given intravenously (IV)

  • VincristineDrug

    Also called Oncovin (R)

    Given intravenously (IV)

  • VinblastineDrug

    Also called Velban (R)

    Given intravenously (IV)

  • PrednisoneDrug

    Also called Prednisolone

    Given orally (PO)

  • FilgrastimDrug

    Also called Neupogen (R)

    Given subcutaneously (SQ) or IV

  • Brentuximab VedotinDrug

    Also called Adcetris

    Given intravenously (IV)

  • CyclophosphamideDrug

    Also called Cytoxan (R)

    Given intravenously (IV)

  • DTICDrug

    Also called DACARBAZINE (R), Dimethyl Triazeno Imidazole Carboximide

    Given intravenously (IV)

  • Quality of Life MeasurementsOther

    Also called Quality of Life Measurements (QOL)

    Quality of Life measurements may be done in low-risk cycles 1 and 2 BEABOVP, intermediate-risk cycles 1, 2 and 3 BEABOVP and high-risk cycles 1 and 2 AEPA and cycles 1, 2, 3, and 4 CAPDac. QOL may be done at year 1, 2 and 5 for all risk groups.

  • RadiotherapyRadiation

    Also called radiation therapy, irradiation

    Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy for all risk groups. Radiotherapy will be administered after completion of all chemotherapy upon hematologic count recovery.

Study groups in NCT03755804
Study groupRoleWhat they receive
Low-RiskExperimentalParticipants receive 2 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.
Receives: Drug: bendamustine; Drug: Etoposide; Drug: Doxorubicin; Drug: Bleomycin; Drug: Vincristine; Drug: Vinblastine; Drug: Prednisone; Drug: Filgrastim; Other: Quality of Life Measurements; Radiation: Radiotherapy
Intermediate-RiskExperimentalParticipants receive 3 cycles of BEABOVP: bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine and prednisone. For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.
Receives: Drug: bendamustine; Drug: Etoposide; Drug: Doxorubicin; Drug: Bleomycin; Drug: Vincristine; Drug: Vinblastine; Drug: Prednisone; Drug: Filgrastim; Other: Quality of Life Measurements; Radiation: Radiotherapy
High-RiskExperimentalParticipants receive 2 cycles of AEPA: Adcedris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) and 4 cycles of CAPDac: cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC). For patients with an AR after 2 cycles of therapy, steroids will be omitted from their subsequent cycles of therapy. Filgrastim may be given as clinically indicated. Dexrazoxane may be given at the discretion of the treating investigator. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy. Quality of Life measurements may be done.
Receives: Drug: Etoposide; Drug: Doxorubicin; Drug: Prednisone; Drug: Filgrastim; Drug: Brentuximab Vedotin; Drug: Cyclophosphamide; Drug: DTIC; Other: Quality of Life Measurements; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate of adequate response

    The 70 evaluable low-risk patients enrolled will be evaluated for this objective.

    Measured: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment

  2. Response rate of adequate response

    The 65 evaluable intermediate-risk patients enrolled will be evaluated for this objective

    Measured: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment

  3. Event-free survival

    Time to event defined as relapse, progression or death. The 115 evaluable high-risk patients participants enrolled will be evaluated for this objective.

    Measured: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment

Secondary outcomes (7)

  1. Number of adverse events in low-risk and intermediate-risk patients

    According to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

    Measured: From enrollment to end of therapy (approximately 8 months

  2. Number of adverse events in high-risk patients

    According to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

    Measured: From enrollment to end of therapy (approximately 8 months

  3. Local failure rate

    Local failure rate in irradiated and non-irradiated patients

    Measured: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment

  4. Event-free survival

    Time to event defined as relapse, progression or death. The EFS for the low-risk patients and intermediate-risk patients are compared to those in HOD08 and HOD05, respectively.

    Measured: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment

  5. Response rate

    Response rate of adequate response after 2 cycles of AEPA in the high-risk patients with FDG-PET compared to that after 2 cycles of AEPA in HLHR13.

    Measured: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment

  6. Response rate

    Response rate of adequate response after 2 cycles of BEABOVP in the low-risk and high-risk patients with FDG-PET compared to those after 2 cycles of STANFORD V chemotherapy in HOD08 and HOD05, respectively.

    Measured: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment

  7. Event-free survival

    Time to event defined as relapse, progression or death. The EFS for the high-risk patients is compared to those in HLHR13.

    Measured: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2018
  2. Study start12 Dec 2018
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03755804
Sponsor's protocol ID
cHOD17
Other IDs
NCI-2018-02924
Status last verified
Jun 2026
First submitted
26 Nov 2018
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bendamustine, Etoposide and Doxorubicin in people with Hodgkin Lymphoma, run by St. Jude Children's Research Hospital at 8 sites 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 16 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Response rate of adequate response (time frame: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03755804.

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 17 Jun 2026.

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