CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma

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Brief Title

CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma

Official Title

Pilot Study of CPI-613, in Combination With Bendamustine, in Patients With Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma

Brief Summary

      The purpose of this study is to determine if it is possible to give CPI-613 with the drug
      Bendamustine for 2 days every 28 days without causing severe side effects. In addition, this
      study will also test the safety of CPI-613 when given in combination with Bendamustine.
    

Detailed Description

      Primary Objectives: A pilot Study to evaluate the feasibility, safety and tolerability of a
      two day course per cycle of Bendamustine plus CPI-613 in patients with relapsed and
      refractory T cell non-hodgkin lymphoma.

      Exploratory Objectives

      To evaluate:

        -  Overall response rate (ORR) and disease control rate (DCR) derived from the Lugano
           classification.

        -  Duration of response (DOR) derived from the Lugano classification.

        -  Progression-Free-Survival (PFS) derived from Lugano classification.

        -  Overall Survival (OS).

        -  Single cell transcriptomics from PMBCs pre- and post-treatment; for correlative analyses
           of blood PBMC (and possibly excess pre-treatment tumor biopsy) cell population diversity
           and functional states to reveal potential mechanisms of drug treatment with regard to
           patient response status.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants To Successfully Complete Therapy Regimen

Secondary Outcome

 Overall Response Rate

Condition

Relapsed T-Cell Lymphoma

Intervention

CPI 613

Study Arms / Comparison Groups

 CPI-613 in Combination with Bendamustine
Description:  CPI-613 at 2500 mg/m2 is infused intravenously (IV) via a central catheter over 2 hrs on Days 1and 2. Bendamustine at 90 mg/m2 is infused IV over 10 minutes on Days 1 and 2 of each treatment cycle, given immediately after CPI-613 administration.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

September 16, 2020

Completion Date

June 2025

Primary Completion Date

June 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must meet all of the following inclusion criteria before enrollment:

          -  Histologically or cytologically confirmed PTCL (all subtypes) or CTCL (mycosis
             fungoides/Sezary syndrome) as defined by 2016 World Health Organization (WHO)
             classification.

        For patients with PTCL:

          -  Patients must have relapsed/refractory disease to one or more systemic therapies.

          -  Patients with CD30-positive lymphoma must have received, be ineligible for, or
             intolerant to brentuximab vedotin.

          -  Patients with limited prior exposure to Bendamustine (less than 2 full cycles or ≤ 480
             mg/m2) may be included, based on PI discretion.

          -  Patients must have measurable disease (e.g., a tumor mass >1 cm or evidence of bone
             marrow involvement).

        For patients with CTCL, Stage IB-IVB mycosis fungoides or Sezary syndrome are eligible

          -  Patients must have relapsed/refractory disease to at least one previous systemic
             therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a
             systemic therapy.

          -  Male and female patients 18 years of age and older

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

          -  Expected survival greater than 3 months.

          -  Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically
             sterile) must use accepted contraceptive methods (abstinence, intrauterine device
             [IUD], oral contraceptive or double barrier device) during the study, and must have a
             negative serum or urine pregnancy test within 1 week prior to treatment initiation.

          -  Fertile men must practice effective contraceptive methods during the study, unless
             documentation of infertility exists.

          -  At least 2 weeks must have elapsed from prior chemotherapy drugs (other than steroids)
             or radiation

          -  At least 6 weeks must have elapsed from prior autologous stem cell transplant and 12
             weeks must have elapsed from prior allogeneic stem cell transplant.

          -  Laboratory values ≤2 weeks must be: Adequate hematological function (absolute
             neutrophil count [ANC] ≥1,500/mm3, platelets ≥100,000/mm3). In subjects with known
             bone marrow involvement, ANC must be ≥ 1000/mm3 and platelets ≥75,000/mm3; Adequate
             hepatic function (aspartate aminotransferase [AST/SGOT] less than or equal to 3x upper
             normal limit [UNL], alanine aminotransferase [ALT/SGPT] less than or equal to 3x UNL
             (≤5x UNL if liver metastases present), bilirubin less than or equal to 1.5x UNL);
             Adequate renal function (serum creatinine less than or equal to 1.5 mg/dL or 133
             µmol/L).

          -  No evidence of current infection.

          -  Mentally competent, ability to understand and willingness to sign the informed consent
             form.

        Exclusion Criteria:

          -  Patients with the following characteristics are excluded:

          -  Known cerebral metastases, central nervous system (CNS) or epidural tumor.

          -  History of prior malignancy and considered to be at greater than 30% risk of relapse

          -  Patients receiving any other standard or investigational treatment for their cancer,
             or any other investigational agent for any indication, within the past 2 weeks prior
             to initiation of treatment with study drugs (steroids are allowed)

          -  Patients with a history of allogeneic transplant must not have ≥ grade 3
             graft-versus-host disease (GVHD) or any clinically significant GVHD requiring systemic
             immunosuppression.

          -  Serious medical illness that would potentially increase patients' risk for toxicity.

          -  Pregnant women, or women of child-bearing potential not using reliable means of
             contraception (because the teratogenic potential of CPI-613 is unknown).

          -  Lactating females.

          -  Fertile men unwilling to practice contraceptive methods during the study period.

          -  Any condition or abnormality which may, in the opinion of the investigator, compromise
             the safety of patients.

          -  Unwilling or unable to follow protocol requirements.

          -  Active heart disease including but not limited to symptomatic congestive heart
             failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic
             myocardial infarction or symptomatic congestive heart failure.

          -  Evidence of current infection..

          -  Patients with known HIV infection, hepatitis B, or hepatitis C with positive viral
             load.

          -  Patients who have received cancer immunotherapy of any type within the past 2 weeks
             prior to initiation of CPI-613 treatment.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rakhee Vaidya, M.B.B.S., 336-716-5440, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04217317

Organization ID

IRB00062873

Secondary IDs

WFBCCC 28419

Responsible Party

Sponsor

Study Sponsor

Wake Forest University Health Sciences

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Rakhee Vaidya, M.B.B.S., Principal Investigator, Wake Forest University Health Sciences


Verification Date

August 2021