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Ann Arbor Stage I Hodgkin LymphomaPhase 2NCT03233347

Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma

A Phase 2 study testing Brentuximab Vedotin, Dacarbazine and Doxorubicin in people with Ann Arbor Stage I Hodgkin Lymphoma and Ann Arbor Stage IA Hodgkin Lymphoma, run by Academic and Community Cancer Research United at 9 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 phase II trial evaluates how well AVD (doxorubicin, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Brentuximab Vedotin, Dacarbazine and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
9 sitesUnited States
Study dates
13 Oct 2017to 8 Jul 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Measurable disease (>= 1.5 cm) as assessed by 2 dimensional measurement by computed tomography (CT)
  • Previously untreated stage I or II non-bulky (defined as a mass measuring < 10 cm in the longest dimension by CT) classical Hodgkin lymphoma
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • Life expectancy >= 3 months
  • Documented negative serologic testing for human immunodeficiency virus (HIV), hepatitis B (unless serologically positive due to prior vaccination), and hepatitis C =< 1 year prior to registration
  • White blood cell >= 2,000 /mm^3 without transfusion support > 7 days prior to registration
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  • Hemoglobin >= 8.5 g/dL without transfusion support > 7 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,000 cells/mm^3 without transfusion support > 7 days prior to registration
  • Platelet count >= 75,000/mm^3 without transfusion support > 7 days prior to registration
  • Alanine and aspartate aminotransferase (ALT/AST) =< 2.5 x upper limit of normal (ULN) obtained =< 14 days prior to registration
  • Total serum bilirubin =< 1.5 x ULN (if documented Gilberts syndrome =< 3 x ULN) obtained =< 14 days prior to registration
  • Serum creatinine =< 1.5 x ULN or measured calculated creatinine clearance >= 40 ml/min for subject with creatinine levels > 1.5 x institutional ULN (per Cockcroft-Gault formula) obtained =< 14 days prior to registration
  • Negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 7 days prior to registration in women of child-bearing potential (WOCBP)
  • Sexually active female of reproductive capability ie, WOCBP, has agreed to use a medically accepted form of contraception from time of registration to completion of study therapy through 24 weeks (6 months) after last dose of NVB or BV; Note: Females of non-child-bearing potential are those who are postmenopausal for > 1 year or who have had a bilateral tubal ligation or hysterectomy
  • Male subjects agree to use an adequate method of contraception starting with the first dose of study therapy through 31 weeks after the last dose of study therapy
  • Provide informed written consent
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  • Note: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up

Who cannot join

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Prior therapies including involved field radiation therapy
  • Bulky disease (defined as a nodal mass measuring >= 10 cm by CT)
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  • Known central nervous system (CNS) involvement
  • Moderate or severe hepatic insufficiency Child-Pugh score > 6
  • Severe renal impairment (i.e. creatinine clearance < 40 mL/min)
  • Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction < 45%, symptomatic coronary artery disease or symptomatic arrhythmias
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy =< 7 days prior to registration
  • Known history of active TB (Bacillus tuberculosis)
  • Requires therapy with agents that have a predisposition for hepatoxicity
  • Hypersensitivity to NVB or any of its excipients or to any component of AVD + BV therapy
  • Requires immunosuppressive doses of corticosteroid therapy (> 10 mg/day prednisone equivalents) for >= 2 weeks prior to registration
  • Active, known, or suspected autoimmune disease that requires systemic treatment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); Note: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • Active infection requiring systemic IV antibiotic therapy
  • History of Steven's Johnson's syndrome, toxic epidermal necrolysis syndrome (TENs) or motor neuropathy
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
  • Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Received a live vaccine =< 30 days prior to registration; Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed; routine vaccinations, including seasonal influenza, must be given >= 2 weeks prior to registration
  • History of allergies and adverse drug reaction to study drug components
  • History of another primary malignancy that has not been in remission for at least 3 years; (Note: The following are exempt for the 3-year limit: nonmelanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear)
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • History of progressive promyelocytic leukemia (PML), known history of pancreatitis, active grade 3 or higher viral, bacterial or fungal infection =< 2 weeks prior to registration and documented history of cerebrovascular event (stroke or transient ischemic attack [TIA]) =< 6 months prior to registration

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: A Phase II Trial of PET-Directed Therapy Using AVD (Doxorubicin, Vinblastine, and Dacarbazine) Plus Brentuximab Vedotin Induction Chemotherapy, With or Without Brentuximab Vedotin Plus Nivolumab, Followed by Nivolumab Consolidation for Patients With Previously Untreated Non-Bulky Limited Stage Hodgkin Lymphoma

This phase II trial evaluates how well AVD (doxorubicin, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab may improve survival of patients with stage I-II Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To estimate progression-free survival (PFS) at 3 years in patients with previously untreated stage I or II non-bulky Hodgkin lymphoma (HL) who received doxorubicin, vinblastine, dacarbazine (AVD) plus brentuximab vedotin (BV) induction therapy followed by nivolumab (N)VB consolidation therapy.

SECONDARY OBJECTIVES:

  1. To estimate the overall survival (OS) rate at 3 years in patients with previously untreated stage I or II non-bulky HL who received AVD plus BV induction therapy followed by NVB consolidation therapy.

II. To estimate the percentage of patients with untreated stage I or II non-bulky HL who are positron emission tomography (PET) positive versus PET negative after 3 cycles of AVD plus BV induction therapy.

III. To estimate PFS and OS at 3 and 5 years separately for patients who are PET negative versus PET positive after 3 cycles of AVD plus BV induction followed by NVB consolidation therapy.

IV. To estimate time to progression (TTP) in patients with previously untreated stage I or II non-bulky HL who received AVD plus BV induction therapy followed by NVB consolidation therapy.

  1. To estimate the overall response rate and the number of patients who convert to complete response (CMR) after NVB in patients with partial response (PMR) at the end of AVD plus BV induction therapy.

VI. To estimate the duration of response in patients with previously untreated stage I or II non-bulky Hodgkin's lymphoma who received AVD plus BV induction therapy followed by NVB consolidation therapy.

VII. To evaluate the toxicity and tolerability of AVD plus BV induction followed by NVB consolidation therapy as assessed via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v]4).

EXPLORATORY OBJECTIVES:

  1. Optional biopsy tissue samples will be collected for future analysis. II. Optional blood sample will be collected for future analysis. III. Cost-benefit analysis of AVD plus BV followed by NVB consolidation, compared to the current standard therapy with adriamycin, bleomycin, vinblastine plus dacarbazine (ABVD) with or without radiation therapy.

OUTLINE:

Patients receive doxorubicin intravenously (IV) over 3-5 minutes, vinblastine IV over 3-5 minutes, and dacarbazine IV over >= 30 minutes, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET-positive then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. PET-positive patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. PET-negative patients receive nivolumab IV over 30 minutes on day 1 starting after AVD and BV treatment. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 and 8 weeks, every 3 or 6 months for 2 years, and then once a year for 3 years.

Being tested
Brentuximab Vedotin, Dacarbazine, Doxorubicin, Laboratory Biomarker Analysis, Nivolumab

What participants receive

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

  • Brentuximab VedotinDrug

    Also called ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35

    Given IV

  • DacarbazineDrug

    Also called 4-(Dimethyltriazeno)imidazole-5-carboxamide, 5-(Dimethyltriazeno)imidazole-4-carboxamide, Asercit, Biocarbazine

    Given IV

  • DoxorubicinDrug

    Also called Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • NivolumabBiological

    Also called BMS-936558, MDX-1106, NIVO, ONO-4538

    Given IV

  • VinblastineDrug

    Also called Vincaleucoblastine, VLB

    Given IV

Study groups in NCT03233347
Study groupRoleWhat they receive
Treatment (combination chemotherapy, nivolumab)ExperimentalPatients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and dacarbazine IV over >= 30 minutes, and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with PET-positive then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. PET-positive patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity. PET-negative patients receive nivolumab IV over 30 minutes on day 1 starting after AVD and BV treatment. Treatment repeats every 2 weeks for 8 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Brentuximab Vedotin; Drug: Dacarbazine; Drug: Doxorubicin; Other: Laboratory Biomarker Analysis; Biological: Nivolumab; Drug: Vinblastine

What is being measured

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

  1. Progression Free Survival

    The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier. 3 year PFS with 95% CI will be reported.

    Measured: 3 years

Secondary outcomes (10)

  1. Overall Survival

    Overall survival time is defined as the time from registration to death due to any cause. The distribution of overall survival time will be estimated using the method of Kaplan-Meier. The rate of overall survival at 3 years and 5 years will be estimated.

    Measured: Time from registration to death due to any cause, assessed at 3 and 5 years

  2. The Proportion of Patients Who Are Positron Emission Tomography (PET) Negative

    The proportion of patients who are PET negative after 3 cycles of treatment will be estimated by the number of patients who are PET negative divided by the total number of evaluable patients. PET will be considered negative if the patient is given a Deauville score of ≤ 3.

    Measured: 3 courses (84 days)

  3. Proportion of Patients Who Are Positron Emission Tomography (PET) Positive

    The proportion of patients who are PET positive after 3 cycles of treatment will be estimated by the number of patients who are PET positive divided by the total number of evaluable patients.

    Measured: 3 courses (84 days)

  4. Progression Free Survival

    Progression-free survival will be evaluated by PET status after 3 cycles of treatment (PET positive vs. PET negative) in patients who complete the cycle 3 response assessment. PFS will be defined as the time from registration to relapse or death due to any cause.

    Measured: From registration, where progression is by CT-based or PET-CT based criteria, assessed at 3 years

  5. Progression Free Survival

    Progression-free survival will be evaluated by PET status after 3 cycles of treatment (PET positive vs. PET negative) in patients who complete the cycle 3 response assessment. PFS will be defined as the time from registration to relapse or death due to any cause.

    Measured: From registration, where progression is by CT-based or PET-CT based criteria, assessed at 5 years

  6. Overall Response Rate (ORR)

    The ORR will be estimated by the number of patients with an complete response (CR)/complete metabolic response/partial response (PR)/partial metabolic response or better divided by the total number of evaluable patients. The ORR may be analysed when all patients are off treatment.

    Measured: 5 years

  7. Time to Progression

    Time to progression is defined as the time from registration to the earliest date of documentation of disease progression (PD or PMD).> Patients who are progression-free will be censored on the date of their last disease assessment. The distribution of time to progression will be estimated using the method of Kaplan-Meier.

    Measured: 5 years

  8. The Proportion of Patients Who Convert From Partial Response at the End of Induction Therapy to Complete Response After Brentuximab Vedotin Plus Nivolumab (NVB)

    The proportion of patients who convert from partial response (PMR) at the end of AVD plus BV induction therapy to complete response> (CMR) after NVB will be estimated by the number of patients who convert divided by the total number of evaluable patients who receive at least one dose of NVB induction therapy. Exact binomial 95% confidence intervals for the true conversion rate will be calculated.

    Measured: 5 years

  9. Median Duration of Response

    Duration of response is defined for all evaluable patients who have achieved a PR or CR as the date at which the patient's objective status is first noted to be a response to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.

    Measured: 5 years

  10. Number of Patients Experiencing Grade 3+ Adverse Events

    Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The number of patients experiencing at least one grade 3 or greater AE regardless of attribution will be reported.

    Measured: 5 years

Timeline

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

  1. First posted28 Jul 2017
  2. Study start13 Oct 2017
  3. Primary completion1 Jul 2025
  4. Study completion8 Jul 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03233347
Sponsor's protocol ID
ACCRU-LY-1601
Other IDs
NCI-2017-01308, ACCRU-LY-1601, P30CA015083
Status last verified
Aug 2026
First submitted
26 Jul 2017
Last updated
15 Sep 2026
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 Brentuximab Vedotin, Dacarbazine and Doxorubicin in people with Ann Arbor Stage I Hodgkin Lymphoma and Ann Arbor Stage IA Hodgkin Lymphoma, run by Academic and Community Cancer Research United at 9 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 18 inclusion and 30 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Yes. Results are posted in the registry (first posted 15 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (time frame: 3 years). 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 NCT03233347.

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 15 Sep 2026.

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