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Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients

ConditionsMycosis FungoidesLymphomatoid PapulosisSezary Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The purpose of this study is to test any good and bad effects of the study drug called brentuximab vedotin at a lower dose than is FDA-approved.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed mycosis fungoides/sezary syndrome at the enrolling institution, disease stage IB (defined as patches, plaque, or papules that involve 10% of the skin surface viscera) or higher

Age ≥ 18 years

ECOG Performance Score ≤ 2

For Cohort 1, patients who have not received brentuximab vedotin are eligible.

Disqualifiers

Topical or systemic steroids (equivalent to ≤ 10 mg/day of prednisone) may be considered if dose has been constant and discontinuation may lead to rebound flare in disease, adrenal insufficiency, and/or unnecessary suffering, after discussion with PI.

If HIV+, patient must be on stable anti-retroviral treatment for 12 weeks prior to C1D1, with CD4 count >200 within 7 days prior to C1D1.

Females of childbearing potential must be on acceptable form of birth control per instutional standard.

Pathologically confirmed lymphomatoid papulosis at the enrolling institution

Trial design

Design model

Sequential

Treatments tested in this trial

  • brentuximab vedotin

    Drug

    MF/SS Brentuximab vedotin 0.9 mg/kg 0R 1.2 mg/kg.

  • brentuximab vedotin

    Drug

    LyP Brentuximab vedotin 0.9 mg/kg2

  • brentuximab vedotin

    Drug

    MF/SS prior brentuximab vedotin-Brentuximab vedotin dose to be determined from Cohort 1

Treatment groups

58 Participants
are divided into 3 treatment groups
Group A: not been previously treated with brentuximab vedotin.Experimental treatment 1 intervention
Group B: treated with reduced dose brentuximab vedotinExperimental treatment 1 intervention
Group C: Patients with LyPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

overall response

measure best overall response during treatment by the global response score, which incorporates the mSWAT, as well as CT scan for patients with baseline nodal/visceral involvement and flow cytometry for patients with baseline positive peripheral flow cytometry

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Seagen Inc.

Collaborator

Source ClinicalTrials.gov
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