Status:
WITHDRAWN
Brentuximab Vedotin and Lenalidomide in Treating Patients With Relapsed or Refractory T-Cell Lymphomas
Lead Sponsor:
City of Hope Medical Center
Conditions:
CD30-Positive Neoplastic Cells Present
Folliculotropic Mycosis Fungoides
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD)/Recommended Phase 2 dose (RP2D) of brentuximab vedotin in combination with lenalidomide in patients with relapsed/ refractory cutaneo...
Eligibility Criteria
Inclusion
- 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
- If received prior brentuximab vedotin or lenalidomide, must be able to tolerate the dose level to which the participant will be enrolled to
- Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Absolute neutrophil count (ANC) \>= 1,000/mm\^3
- \* NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
- Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Platelets \>= 75,000/mm\^3
- \* NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
- Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Total bilirubin =\< 1.5 X upper limit of normal (ULN) OR if Gilbert's syndrome =\< 3.0 X ULN
- Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Aspartate aminotransferase (AST) =\< 2 x ULN
- Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Alanine aminotransferase (ALT) =\< 2 x ULN
- Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Creatinine clearance of \>= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula
- Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by WOCBP and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy \* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion
- 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
- Allergic reaction/hypersensitivity to lenalidomide or history of anaphylactic shock to brentuximab vedotin in the past
- Female only: pregnant or breastfeeding
- Acute infection requiring systemic treatment
- Known history of human immunodeficiency virus (HIV) infection
- Active hepatitis B or C infection
- Central nervous system involvement by lymphoma, including leptomeningeal involvement
- History of progressive multifocal leukoencephalopathy (PML)
- Current peripheral neuropathy \>= grade 2 or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
- Unstable cardiac disease as defined by one of the following:
- Cardiac events such as myocardial infarction (MI) within the past 6 months
- NYHA (New York Heart Association) heart failure class III-IV
- Uncontrolled atrial fibrillation or hypertension
- History of vascular disease (e.g. deep vein thrombosis, stroke)
- Major surgery (as defined by the investigator) within the 28 days prior to day 1 of protocol therapy
- Incidence of gastrointestinal disease that may significantly alter the absorption of lenalidomide
- Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/psychological issues, etc.
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03373305
Start Date
March 1 2019
End Date
April 26 2019
Last Update
April 30 2019
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010