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Brentuximab Vedotin in Treating Patients with Relapsed or Refractory Mature T Cell Lymphoma

Trial Status: Active

This phase II trial studies how well brentuximab vedotin works in treating patients with mature T cell lymphoma that has returned after a period of improvement or has not responded to previous treatment. Immunotoxins, such as brentuximab vedotin, are antibodies linked to a toxic substance and may help find cancer cells that express cluster of differentiation (CD)30 and kill them without harming normal cells.

Inclusion Criteria

  • Patients must have histologically or cytologically confirmed relapsed/refractory CD30 low (< 10%) TCL: * Peripheral TCL not otherwise specified (PTCL NOS) * Angioimmunoblastic T cell lymphoma (AITL) * Hepato-splenic T cell lymphoma (HTCL) * Adult T cell leukemia/lymphoma (ATLL) * Enteropathy associated T cell lymphoma (EATL) * Natural killer (NK) T cell lymphoma (NK/TCL)
  • At least 1 prior chemotherapy regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2; ECOG performance status (PS) 3 will be permitted if the decreased PS is attributed to the lymphoma
  • Absolute neutrophil count >= 1,000/mcL (unless documented bone marrow involvement with lymphoma)
  • Platelet count >= 50,000/uL (unless documented bone marrow involvement with lymphoma)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3 x ULN even in patients with documented hepatic involvement with lymphoma
  • Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN even in patients with documented hepatic involvement with lymphoma
  • Serum creatinine clearance >= 30 ml/min
  • At least 6 weeks from autologous stem cell transplantation
  • At least 3 months from allogeneic stem cell transplantation and off immunosuppression and no evidence of graft versus host disease (GVHD)
  • Previous treatment with brentuximab vedotin will be allowed if it was done 6 months prior to enrollment and was not refractory to or had progressive disease (PD) on brentuximab vedotin (BV)
  • Measurable disease >= 1.5 cm seen on computed tomography (CT) scan and fludeoxyglucose F-18 (FDG) avid disease on positron emission tomography (PET) scan; splenomegaly measuring > 12 cm, if attributed to TCL and/or positive bone marrow involvement with lymphoma are also eligible
  • Females of childbearing potential must have a negative serum or urine pregnancy test result within 7 days prior to the first dose of study treatment; women of childbearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) for the duration of study participation and for 6 months after completing treatment; should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately; males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of study drug
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Myocardial infarction within the past 6 months
  • Patients who are receiving any other chemotherapy or investigational agents; radiation treatment will not be permitted during study treatment; patients can receive radiation therapy (XRT) 2 weeks prior to study drug administration or 4 weeks post study completion or discontinuation; steroids equivalent to prednisone 60 mg daily are permitted prior to study drug administration, but needs to be discontinued 1 day prior to BV administration; patients receiving steroids for lymphoma symptoms should have measurable disease as mentioned above on baseline scans
  • Presence of central nervous system (CNS) involvement requiring active treatment
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to brentuximab vedotin
  • Cutaneous T cell lymphomas except transformed mycosis fungoides (MF)
  • Prior treatment with brentuximab in the last 6 months or had refractory or progressive disease to prior BV treatment
  • Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • History of progressive multifocal leukoencephalopathy (PML)
  • Pregnancy or breast-feeding women; breastfeeding should be discontinued if the mother is treated with brentuximab vedotin
  • A known history of human immunodeficiency virus (HIV)
  • Presence of grade > 2 peripheral neuropathy or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
  • Prior malignancy within the past 3 years except non-melanoma skin cancer or other localized cancer treated with curative intent
  • Patients with the following medical conditions that could affect their participation in the study: * Any active acute or chronic or uncontrolled infection * Liver disease including history of viral hepatitis B or C, evidence of cirrhosis, chronic active or persistent hepatitis * Symptomatic cardiac disease, including congestive heart failure, coronary artery disease, and arrhythmias

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Ryan Wilcox
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE
Contact: Erlene Kuizon Seymour

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE
Contact: Tatyana A. Feldman
Phone: 551-996-3925

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE
Contact: Deepa Jagadeesh
Phone: 216-444-0857

PRIMARY OBJECTIVE:

I. To determine overall response rate (complete response [CR] + partial response [PR]) of brentuximab vedotin in CD30 low (< 10%) relapsed or refractory T cell lymphoma (TCL).

SECONDARY OBJECTIVES:

I. Complete remission (CR) rate.

II. Duration of response (DOR).

III. Progression free survival (PFS).

IV. Overall survival (OS).

V. Time to treatment failure (TTF).

LAB CORRELATIVE OBJECTIVE:

I. To assess and compare the sensitivity of immunohistochemistry (IHC) with multi spectral imaging analysis and reverse transcriptase-polymerase chain reaction (RT PCR) methods to detect CD30.

OUTLINE:

Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at for 30 days, and at 6, 12, 24, and 36 months.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Case Comprehensive Cancer Center

Principal Investigator
Deepa Jagadeesh

  • Primary ID CASE1415
  • Secondary IDs NCI-2016-00018
  • Clinicaltrials.gov ID NCT02588651