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Recurrent Hodgkin LymphomaPhase 1/2NCT03739619

Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

A Phase 1/2 study testing Bendamustine, Gemcitabine and Nivolumab in people with Recurrent Hodgkin Lymphoma and Refractory Hodgkin Lymphoma, run by Emory University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I/II trial studies the side effects and best dose of gemcitabine, bendamustine, and nivolumab when given together and to see how well they work in treating patients with classic Hodgkin lymphoma that has come back or does not respond to treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bendamustine, Gemcitabine and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesUnited States
Study dates
26 Nov 2018to 30 Apr 2025
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically documented classical Hodgkin lymphoma that is recurrent or refractory after standard chemotherapy. Core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping. Bone marrow biopsies as the sole means of diagnosis are not acceptable. At least one biopsy-proven relapse is required for enrollment, but patients who have multiply relapsed disease do not require repeat biopsy if not clinically indicated
  • Prior treatment: patients must have relapsed or progressed after at least one prior therapy
  • Patients with relapsed or refractory disease following autologous stem cell transplantation are permitted. Due to the risk of treatment-refractory graft versus host disease (GVHD), patients who have previously completed an allogeneic transplant are excluded.
  • Patients may have received gemcitabine, bendamustine, or nivolumab in the past but may not have discontinued therapy due to toxicity felt to be related to that specific drug
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Measurable disease must be present either on physical examination or imaging studies. Non-measurable disease alone is not acceptable
Show all 31Show fewer
  • Measurable disease
  • Lesions that can be accurately measured in at least two dimensions as ≥ 1.0 x 1.0 cm by computerized tomography (CT), positron emission tomography (PET)/CT (positron emission tomography/CT), or magnetic resonance imaging (MRI).
  • If identified by PET/CT, there must be at least one lesion that demonstrates abnormal fludeoxyglucose (FDG) avidity, consistent with active disease. Ultrasound or physical examination alone may not be utilized to confirm measurable disease
  • Non-measurable disease
  • All other lesions, including small lesions (less than 1.0 x 1.0 cm) and truly non-measurable lesions
  • Lesions that are considered non-measurable include the following:
  • Bone lesions (lesions if present should be noted)
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Bone marrow (involvement by Hodgkin lymphoma should be noted)
  • Non-pregnant and non-nursing. Women and men of reproductive potential should agree to use an effective means of birth control
  • Patients with human immunodeficiency virus (HIV) infection are eligible. Patients with HIV infection must meet the following: no evidence of co-infection with hepatitis B or C; cluster of differentiation 4+ (CD4+) count ≥ 400/mm; no evidence of resistant strains of HIV; on anti-HIV therapy with an HIV viral load < 50 copies HIV ribonucleic acid (RNA)/mL. Patients with HIV must have ongoing follow-up with an infectious disease specialist and must have been evaluated within 90 days of cycle 1 day 1
  • Patients with a history of hepatitis C are eligible as long as the hepatitis C has been treated and cleared and they have no evidence of hepatic dysfunction related to hepatitis C. Patients must have been seen by a hepatologist within 6 months of cycle 1 day 1
  • Patients who test positive for hepatitis B core antibody may enroll on the study as long as they test negative for both hepatitis B surface antigen and hepatitis B deoxyribonucleic acid (DNA), and if they have no evidence of hepatic dysfunction that is felt to be related to hepatitis B
  • Patients must have adequate pulmonary function, defined as the following:
  • No history of drug-related, radiation-induced, or autoimmune pneumonitis requiring hospital admission
  • Baseline pulse oximetry reading of ≥ 92% on room air
  • Patients with a history of asthma or chronic obstructive pulmonary disease (COPD) must have no oxygen requirement, must have not had a hospital admission for COPD/asthma exacerbation within the past 2 years, and must not have received systemic steroids (≥ 10 mg prednisone for more than 7 days) for asthma/COPD within the past 2 years
  • Patients with hypothyroidism or type 1 diabetes mellitus that are on chronic hormonal therapy and which are well-controlled are eligible
  • Granulocytes ≥ 1000/µl
  • Platelet count ≥ 75,000/µl
  • Creatinine clearance ≥ 50 mL/min
  • Bilirubin ≤ 2.0 mg/dL
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.0 x upper limits of normal

Who cannot join

  • Due to the teratogenic potential of these agents, pregnant or nursing patients may not be enrolled
  • Patients may not have an auto-immune disease requiring systemic immunosuppression, biologic therapy, and/or steroid use (≥ 10 mg daily of prednisone or equivalent)
  • Patients with current or prior central nervous system (CNS) involvement with lymphoma are not eligible

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

Other trials in United States

About this study

Official title: A Phase I/II Study of Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

This phase I/II trial studies the side effects and best dose of gemcitabine, bendamustine, and nivolumab when given together and to see how well they work in treating patients with classic Hodgkin lymphoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as gemcitabine and bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving gemcitabine, bendamustine, and nivolumab may work better in treating patients with classic Hodgkin lymphoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the toxicity and determine the maximum tolerated dose (MTD) of combined gemcitabine, bendamustine, and nivolumab in patients with relapsed/refractory classical Hodgkin lymphoma.

II. To determine the efficacy of bendamustine, gemcitabine, and nivolumab in patients with relapsed/refractory classical Hodgkin lymphoma.

SECONDARY OBJECTIVES:

  1. To evaluate the duration of response, progression-free survival, and overall survival for patients with relapsed/refractory classical Hodgkin lymphoma who receive gemcitabine, bendamustine, and nivolumab, including those who receive nivolumab maintenance.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive gemcitabine intravenously (IV) over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Medical subject headings
Hodgkin Disease

What participants receive

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

  • BendamustineDrug

    Also called Bendamustine Hydrochloride, Cytostasan Hydrochloride, Levact, Ribomustin

    Given IV

  • GemcitabineDrug

    Also called dFdC, dFdCyd, Difluorodeoxycytidine

    Given IV

  • NivolumabBiological

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

    Given IV

Study groups in NCT03739619
Study groupRoleWhat they receive
Gemcitabine, bendamustine, nivolumabExperimentalPatients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Bendamustine; Drug: Gemcitabine; Biological: Nivolumab

What is being measured

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

  1. Maximum Tolerable Dose (Phase I)

    Maximum tolerable dose will be defined as the highest dose level where at most 1 of 6 patients experience dose limiting toxicity (DLT).

    Measured: Up to completion of course 2 at 42 days after study start

  2. Complete Response (CR) Rate (Phase II)

    Complete response rate will be determined by dividing the number of CRs (per Lugano criteria) by the total number of evaluable patients.

    Measured: Up to 2 years from discontinuation of study therapy

Secondary outcomes (4)

  1. Overall Response Rate (Phase II)

    Overall response rate will be evaluated using Lugano criteria of response. Overall response rate will be defined as the total number of patients achieving a partial response or CR as best response through cycle 6 divided by total number of patients treated.

    Measured: Up to 2 years from discontinuation of study therapy

  2. Duration of Response (Phase II)

    Duration of response will be evaluated using Lugano criteria of response and will be determined from date of best response to progression or death.

    Measured: Up to 2 years from discontinuation of study therapy

  3. Progression Free Survival (PFS) (Phase II)

    Progression free survival will be evaluated using Lugano criteria and will be determined from date of first dose of study drug to progression or death.

    Measured: Up to 2 years from discontinuation of study therapy

  4. Overall Survival (OS) (Phase II)

    Overall survival will be evaluated using Lugano criteria and will be determined from date of first dose of study drug to death from any cause.

    Measured: Up to 2 years from discontinuation of study therapy

Timeline

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

  1. First posted14 Nov 2018
  2. Study start26 Nov 2018
  3. Primary completion22 Dec 2023
  4. Study completion30 Apr 2025

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03739619
Sponsor's protocol ID
IRB00104033
Other IDs
NCI-2018-02221, Winship4388-18, P30CA138292
Status last verified
Jul 2025
First submitted
1 Nov 2018
Last updated
6 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bendamustine, Gemcitabine and Nivolumab in people with Recurrent Hodgkin Lymphoma and Refractory Hodgkin Lymphoma, run by Emory University at 2 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 31 inclusion and 3 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 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 6 Aug 2025). 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?

Maximum Tolerable Dose (Phase I) (time frame: Up to completion of course 2 at 42 days after study start). The study lists 2 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 NCT03739619.

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 6 Aug 2025.

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