Recurrent Chronic Lymphocytic LeukemiaPhase 2NCT04205409
Nivolumab for Relapsed, Refractory, or Detectable Disease Post Chimeric Antigen Receptor T-cell Treatment in Patients With Hematologic Malignancies
A Phase 2 study testing Nivolumab in people with Recurrent Chronic Lymphocytic Leukemia and Recurrent Diffuse Large B-Cell Lymphoma, run by University of Washington at 1 site in United States.
Trial summary
This phase II trial studies how well nivolumab works for the treatment of hematological malignancies that have come back (relapsed), does not respond (refractory), or is detectable after CAR T cell therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Chronic Lymphocytic Leukemia, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Follicular Lymphoma
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2020to 5 Jan 2026
- Phase
- Phase 2
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
- Diagnosis of the following tumor types
- Non Hodgkin-lymphoma, including:
- Diffuse large B-cell lymphoma: Histopathologic confirmation
- Mantle cell lymphoma: Histopathologic confirmation
- Follicular lymphoma, all grades: Histopathologic confirmation
- Marginal zone lymphoma: Histopathologic confirmation
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- Chronic lymphocytic leukemia: Histopathologic or flow cytometric confirmation
- Multiple myeloma: Histopathologic or flow confirmation
- Relapsed, refractory, or detectable disease after treatment with chimeric antigen receptor T-cells
- Multiple Myeloma: patients must have exhausted all treatment options known to provide clinical benefit, and are refractory to a minimum of 3 prior lines of therapy (including an immunomodulatory imide drug [IMiD], proteasome inhibitor [PI], or anti-CD38 monoclonal antibody)
- Have measurable disease, defined by histology:
- Non-Hodgkin's lymphoma, based on presence of lesions >= 1.5 cm that can be accurately measured in 2 dimensions by computed tomography (CT) (preferred) or magnetic resonance imaging (MRI), and are not included in any prior field of radiation therapy
- Chronic lymphocytic leukemia: circulating lymphocytes >= 5,000 / mm^3
- Multiple myeloma, based on the International Myeloma Working Group (IMWG) criteria of having one or more of the following findings:
- Serum M protein >= 1.0 g/dL
- Urine M protein >= 200 mg/24 hours
- Involved serum free light chain level >= 10 mg/dL with abnormal kappa/lambda ratio
- Measurable biopsy-proven plasmacytomas (>= 1 lesion has a single diameter >= 2 cm)
- Bone marrow plasma cells >= 30%
- Age 18 years and older, and have the capacity to give informed consent
- Anticipated survival of > 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Post CAR T cell receipt of intervening palliative radiation therapy is allowed
- Estimated glomerular filtration rate (eGFR) >= 20 ml/min
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
- Total bilirubin =< 2 x ULN
- Absolute neutrophil count (ANC) >= 1,000/uL
- Platelets >= 50,000/uL
- Hemoglobin >= 8 g/dL
Who cannot join
- Receipt of intervening therapy after CAR T-cell infusion
- History of another primary malignancy that has not been in remission for at least 1 year (with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer, curatively treated superficial bladder cancer and cervical carcinoma in site on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear)
- Active hepatitis B, hepatitis C at time of screening
- Known (human immunodeficiency virus [HIV]) seropositivity
- Subjects with uncontrolled infection
- Concurrent use of other anticancer agents or experimental treatments
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- Active autoimmune disease requiring immunosuppressive therapy with the exception of vitiligo and autoimmune alopecia
- Known active central nervous system (CNS) involvement
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses are permitted in absence of active autoimmune disease
- Known history of any active infectious pneumonitis
- Presence of acute or chronic graft-versus-host disease (GVHD) requiring active treatment unless limited to skin involvement and managed with topical steroid therapy alone
- Has active cytokine release syndrome
- Pregnancy or breastfeeding: Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (urine pregnancy test: minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 14 days of the first dose of study drug. Women must not be breastfeeding. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Females of childbearing potential and males who have partners of childbearing potential must agree to use 2 effective contraceptive methods during the study and for 8 months following the last dose of nivolumab
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Nivolumab for Relapsed or Refractory Disease Post Chimeric Antigen Receptor T-Cell Treatment in Patients With Hematologic Malignancies
This phase II trial studies how well nivolumab works for the treatment of hematological malignancies that have come back (relapsed), does not respond (refractory), or is detectable after CAR T cell therapy. 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.
Read the detailed description
OUTLINE:
Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then for up to 5 years.
- Conditions
- Recurrent Chronic Lymphocytic Leukemia, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Follicular Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma
- Being tested
- Nivolumab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Non-Hodgkin, Multiple Myeloma, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called 946414-94-4, BMS-936558, MDX-1106, NIVO
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (nivolumab) | Experimental | Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response Rate (ORR)
Assessed by disease-specific guidelines: multiple myeloma - International Myeloma Working Group response criteria, non-Hodgkin lymphoma - Response assessment will be based on the Lugano Criteria, and chronic lymphocytic leukemia - Response assessment based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria. ORR will be estimated, and its corresponding 95% exact binomial confidence interval (CI) will be provided.
Measured: Up to 1 year and 8 months
Secondary outcomes (4)
Overall Survival
Will employ Kaplan-Meier and Cox proportional hazard model methodology.
Measured: From the first study drug administration to death from any cause, up to 5 years
Progression-free Survival
Will employ Kaplan-Meier and Cox proportional hazard model methodology.
Measured: From first study drug administration to the first occurrence of disease progression or death from any cause, up to 1 year and 8 months
Duration of Response
Will employ Kaplan-Meier and Cox proportional hazard model methodology.
Measured: Up to 1 year and 7 months
Incidence of Adverse Events
Will be determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Safety data will be summarized descriptively. Adverse events will be summarized by severity, seriousness, and relationship to study drug.
Measured: Up to 30 days after the last dose of study drug, up to a maximum of 1 year and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start5 Jun 2020
- Primary completion20 Sep 2024
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Rahul Banerjee, MD, University of Washington
- Investigators
- Rahul Banerjee, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205409
- Sponsor's protocol ID
- RG1005491
- Other IDs
- NCI-2019-08192, 10388
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2019
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No