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Lymphoma, Large B-Cell, DiffusePhase 1NCT02086604

Brentuximab Vedotin and Lenalidomide for Relapsed or Refractory Diffuse Large B-cell Lymphoma

A Phase 1 study testing Brentuximab vedotin and Lenalidomide in people with Lymphoma, Large B-Cell, Diffuse, run by Washington University School of Medicine 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 clinical trial studies the side effects and maximum tolerated dose (MTD) of the combination of brentuximab vedotin (BV) and lenalidomide in the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Large B-Cell, Diffuse
What is being tested?
Brentuximab vedotin and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesUnited States
Study dates
18 Sep 2014to 12 Jan 2022
Phase
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Relapsed or refractory de novo or transformed DLBCL disease following at least one prior systemic therapy (for DLBCL).
  • CD30 immunohistochemical staining using the anti-CD30 BerH2 antibody must be available on the most recent biopsy specimen. During dose escalation, patients can be either CD30 positive or CD30 negative. During dose expansion, 15 patients must be CD30 positive and 15 patients must be CD30 negative.
  • Post-ASCT or not a candidate for ASCT. Prior allogeneic stem cell transplant is allowed if patient is off all immunosuppressives and has no evidence of active GVHD.
  • Prior treatment with brentuximab vedotin is allowed provided the patient did not progress on BV or within 30 days of last dose of BV. Patients must be at least 3 months from the last dose of BV.
  • Bidimensional measurable disease of at least 1.5 cm in the greatest transverse diameter as documented by CT or PET/CT.
  • At least 18 years of age.
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  • ECOG performance status ≤ 2
  • Bone marrow and organ function as defined below:
  • Absolute neutrophil count (ANC) ≥ 1,000/mcl
  • Platelets ≥ 50,000/mcl
  • Serum bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) OR serum bilirubin ≤ 3.0 x IULN for patients with Gilbert's disease or documented hepatic involvement with NHL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x IULN OR ALT and AST ≤ 5.0 x IULN for patients with documented hepatic involvement with NHL
  • Creatinine clearance ≥ 60 mL/min/1.73 m2 as calculated by Cockcroft-Gault
  • Women of childbearing potential must follow pregnancy testing requirements as outlined in the Revlimid REMS® program material. This is defined as either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of contraception (one highly effective method and one additional effective method AT THE SAME TIME) at least 28 days prior to the start of lenalidomide, for the duration of study participation, and for 28 days following the last doses of brentuximab vedotin and lenalidomide. Women of childbearing potential must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a woman of childbearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • All study participants must be registered into the mandatory Revlimid REMS® program and be willing to comply with its requirements. Per standard Revlimid REMS® program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS® program.
  • Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Who cannot join

  • Primary mediastinal B-cell lymphoma
  • A history of other primary invasive malignancy that has not been in remission for at least 3 years or a current diagnosis of myelodysplastic syndrome (MDS) or an immature leukemia such as acute myeloid leukemia (AML).
  • Known active cerebral/meningeal lymphoma.
  • Present or history of progressive multifocal leukoencephalopathy (PML).
  • NYHA Class III or IV congestive heart failure.
  • Active CTCAE version 4.03 grade 3 or higher viral, bacterial, or fungal infection.
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  • Known to be positive for hepatitis B by surface antigen expression and hepatitis B core antibody.
  • Known to have active hepatitis C infection (positive by polymerase chain reaction) or on antiviral therapy for hepatitis C within 6 months prior to the first doses of brentuximab vedotin and lenalidomide.
  • Known to be positive for HIV.
  • Receiving chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed at least 3 weeks prior to study entry, unless underlying disease is progressing on therapy.
  • Currently receiving any other investigational agents.
  • Known hypersensitivity to any excipient contained in the drug formulation of brentuximab vedotin or lenalidomide.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide.
  • Receiving immunosuppressive therapy.
  • Refractory to prior therapy with brentuximab vedotin (evidence of progression within 30 days of the last dose).
  • Prior therapy with lenalidomide.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Ohio State University, James Cancer Hospital

    Columbus, Ohio, 43210

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I Trial of Brentuximab Vedotin in Combination With Lenalidomide in Relapsed or Refractory Diffuse Large B-cell Lymphoma

This Phase I clinical trial studies the side effects and maximum tolerated dose (MTD) of the combination of brentuximab vedotin (BV) and lenalidomide in the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Being tested
Brentuximab vedotin, Lenalidomide
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.

  • Brentuximab vedotinDrug

    Also called Adcetris®

  • LenalidomideDrug

    Also called Revlimid®

Study groups in NCT02086604
Study groupRoleWhat they receive
Starting Dose (brentuximab vedotin & lenalidomide)ExperimentalBrentuximab vedotin 1.2 mg/kg intravenously (IV) on Day 1 of every 21 day cycle. Lenalidomide 20 mg orally on Days 1-21 of every 21 day cycle.
Receives: Drug: Brentuximab vedotin; Drug: Lenalidomide
Dose Level 1 (brentuximab vedotin & lenalidomide)ExperimentalBrentuximab Vedotin 1.2 mg/kg intravenously (IV) on Day 1 of every 21 day cycle. Lenalidomide 20 mg orally on Days 1-21 of every 21 day cycle.
Receives: Drug: Brentuximab vedotin; Drug: Lenalidomide
Dose Level 2 (brentuximab vedotin & lenalidomide)ExperimentalBrentuximab Vedotin 1.2 mg/kg intravenously (IV) on Day 1 of every 21 day cycle. Lenalidomide 20 mg orally on Days 1-21 of every 21 day cycle.
Receives: Drug: Brentuximab vedotin; Drug: Lenalidomide

What is being measured

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

  1. Safety as measured by grade and frequency of adverse events

    Adverse events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Measured: 30 days after completion of treatment

  2. Maximum Tolerated Dose (MTD) as measured by the number of dose-limiting toxicities in each dose level (cohort)

    MTD is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed until the MTD has been reached.

    Measured: Completion of the first cycle for all participants in dose expansion phase (approximately 12 months)

Secondary outcomes (4)

  1. Objective response rate as measured by CD30 expression

    The objective response rate by CD30 expression (proportion of positive cells, staining intensity, or both) is defined as the proportion of patients with CR or PR stratified by different values or categories of CD30 expression. Positive CD30 expression is defined as ≥1% staining of the malignant cells.

    Measured: Up to 2 years after discontinuation of treatment

  2. Overall response rate

    Complete response rate (CR) + Partial response rate (PR) = Overall response rate according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).

    Measured: Up to 2 years after discontinuation of treatment

  3. Duration of response

    Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (including radiographic and clinical progression) or to death due to any cause, whichever comes first.

    Duration of response data will be censored on the day following the date of the last disease assessment documenting absence of progressive disease for patients who do not have tumor progression and are still on study at the time of an analysis, are given antitumor treatment (including stem cell transplant) other than the study treatment, or are removed from study prior to documentation of tumor progression.

    Duration of response will only be calculated for the subgroup of patients achieving a CR or PR.

    Measured: Up to 2 years after discontinuation of treatment

  4. Progression-free survival (PFS)

    PFS is defined as the time from start of study treatment to first documentation of tumor progression (including radiographic and clinical progression) or to death due to any cause, whichever comes first.

    PFS data will be censored on the day following the date of the last disease assessment documenting absence of progressive disease for patients who do not have tumor progression and are still on study at the time of an analysis, are given antitumor treatment (including stem cell transplant) other than the study treatment, or are removed from study prior to documentation of tumor progression. Patients lacking an evaluation of tumor response after their first dose will have their event time censored at 1 day.

    Measured: Up to 2 years after discontinuation of treatment

Timeline

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

  1. First posted13 Mar 2014 (estimated)
  2. Study start18 Sep 2014
  3. Primary completion9 Jun 2017
  4. Study completion12 Jan 2022

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02086604
Sponsor's protocol ID
201404056
Status last verified
Feb 2022
First submitted
11 Mar 2014
Last updated
17 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ward JP, Berrien-Elliott MM, Gomez F, Luo J, Becker-Hapak M, Cashen AF, Wagner-Johnston ND, Maddocks K, Mosior M, Foster M, Krysiak K, Schmidt A, Skidmore ZL, Desai S, Watkins MP, Fischer A, Griffith M, Griffith OL, Fehniger TA, Bartlett NL. Phase 1/dose expansion trial of brentuximab vedotin and lenalidomide in relapsed or refractory diffuse large B-cell lymphoma. Blood. 2022 Mar 31;139(13):1999-2010. doi: 10.1182/blood.2021011894.

    PubMed 34780623

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Brentuximab vedotin and Lenalidomide in people with Lymphoma, Large B-Cell, Diffuse, run by Washington University School of Medicine 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 16 inclusion and 16 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 17 Feb 2022. 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 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.

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?

Safety as measured by grade and frequency of adverse events (time frame: 30 days after completion of treatment). 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 NCT02086604, which also lists 1 linked publication.

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 Feb 2022; AzTrials last refreshed its copy on 29 Oct 2026.

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