Brentuximab Vedotin and Lenalidomide in Treating Patients With Relapsed or Refractory T-Cell Lymphomas

NCT03373305 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: 17347NCI-2017-02163
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of lenalidomide when given together with brentuximab vedotin in treating patients with T-cell lymphomas that have come back or do not respond to treatment. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin and lenalidomide may work better in treating patients with T-cell lymphomas.

Conditions

CD30-Positive Neoplastic Cells Present; Folliculotropic Mycosis Fungoides; Recurrent Mycosis Fungoides; Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Refractory Mycosis Fungoides; Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Sezary Syndrome

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity (DLT) assessed per CTCAE v4.0

  Up to 21 days

Secondary Outcomes (5)

• Rate of objective global response defined as proportion of patients achieving complete response (CR)/partial response (PR) that lasts at least 4 months

  At 4 months

• Complete response defined as proportion of patients achieving CR according to Olsen criteria

  Up to 1 year

• Progression free survival (PFS) according to Olsen criteria

  From start of protocol treatment to first observation of disease relapse/ progression or death from any cause, whichever occurs first, assessed up to 1 year

• Change in pruritus visual analogue scale (VAS)

  Up to 1 year

• CD30 expression assessed by lymph node and/or skin biopsies via immunochemistry

  Baseline

Study Arms (1)

Treatment (brentuximab vedotin, lenalidomide)

EXPERIMENTAL

Patients receive brentuximab vedotin IV over 30 minutes on day 1 and lenalidomide PO QD on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Drug: Brentuximab Vedotin; Drug: Lenalidomide; Other: Laboratory Biomarker Analysis

Interventions

Brentuximab Vedotin DRUG

Given IV

Also known as: 914088-09-8, ADC SGN-35, Adcetris, Anti-CD30 Antibody-Drug Conjugate SGN-35, Anti-CD30 Monoclonal Antibody-MMAE SGN-35, Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35, Brentuximab Vedotin, cAC10-vcMMAE, SGN-35

Treatment (brentuximab vedotin, lenalidomide)

Lenalidomide DRUG

Given PO

Also known as: 191732-72-6, 3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6-dione, 703813, CC-5013, CC5013, CDC 501, Revlimid

Treatment (brentuximab vedotin, lenalidomide)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (brentuximab vedotin, lenalidomide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative
• Registered into mandatory Revlimid Risk Evaluation and Mitigation Strategies (REMS) program
• Women of childbearing potential: adhere to scheduled pregnancy testing as required in the Revlimid REMS program
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Histologically confirmed cutaneous T-cell non-Hodgkin lymphoma (CTCL) per World Health Organization (WHO) classification 2016 including, mycosis fungoides (MF) or Sezary syndrome (SS); phase 1 : \>= stage IIB OR \>= stage IB-IIA folliculotropic/transformed MF; expansion cohort: \>= stage IB
• MF/SS stage of disease according to TNMB classification
• SS is defined as meeting T4 plus B2 criteria; where the biopsy of erythrodermic skin may only reveal suggestive but not diagnostic histopathologic features, the diagnosis may be based on either node biopsy or fulfillment of B2 criteria
• For MF where the histological diagnosis by light microscopic examination is not confirmed, diagnostic criteria that been recommended by the International Society for Cutaneous Lymphomas (ISCL) should be used
• Relapsed/refractory disease
• Failed \>= 2 prior systemic therapies
• CD30-positivity by immunohistochemistry of \>= 1%
• Measurable disease per modified Severity Weighted Assessment and/or Sezary count
• Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =\< grade 1
• May have received either brentuximab vedotin or lenalidomide/immunomodulatory imide drugs (IMiD) without dose modification/delay due to toxicity
• \* IMiDs defined as thalidomide analogues

You may not qualify if:

• Stem cell transplantation
• Monoclonal antibody within 28 days prior to day 1 of protocol therapy
• Any systemic therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating day 1 of protocol therapy
• Any skin-directed therapy within 14 days prior to day 1 of protocol therapy
• Any radiation therapy within 21 days prior to day 1 of protocol therapy
• Immunosuppressive medication within 14 days prior to day 1 of protocol therapy; the following are exceptions to this criterion:
• Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection) and are on stable dose for at least 28 days
• Systemic corticosteroids at physiologic doses of \< 10 mg/day of prednisone or equivalent
• Live, attenuated vaccine within 30 days prior to day 1 of protocol therapy
• Disease free of prior malignancies for \>= 5 years with the exception of:
• Currently treated squamous cell and basal cell carcinoma of the skin, or
• Carcinoma in situ of the cervix, or
• Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision , or
• Prostate cancer (T1a or T1b using the TNM \[tumor, nodes, metastasis\] clinical staging system) that has/have been surgically cured, or
• Any other malignancy that has/have been curatively treated with surgery and/or localized radiation

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous; Sezary Syndrome

Interventions

Brentuximab Vedotin; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jasmine Zain, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 14, 2017
• Study Start: March 1, 2019
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Locations

US (1)