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

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ClinicalTrials.gov Identifier: NCT04217317
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE December 31, 2019
First Posted Date  ICMJE January 3, 2020
Last Update Posted Date July 7, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2019)
Number of Participants To Successfully Complete Therapy Regimen [ Time Frame: 8 weeks after first dose ]
Feasibility will be defined as 75% of patients being successfully able to complete 80% of their therapy regimens. Toxicity data will be collected on all patients who receive at least one dose of treatment on the study
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2019)
  • Overall Response Rate [ Time Frame: Up to 12 weeks post treatment ]
    Overall response rate is defined as the proportion of patients who achieve a best overall response complete response or partial response during or following study treatment according to the Lugano Classification (Stage I - involvement in a single lymph node region to Stage IV diffuse or disseminated involvement of one or more extranodal organs or tissue).
  • Disease Control Rate [ Time Frame: Up to 12 weeks post treatment ]
    Disease control rate defined as the proportion of patients who achieve a best overall response of complete response, partial response, or stable disease (SD). Best overall response of stable disease must have met the response stable disease criteria at least once ≥12 weeks after start of study treatment.
  • Duration of Response [ Time Frame: Up to 12 weeks post treatment ]
    Duration of Response will be defined for responders (patients with a best overall response of complete response or partial response). It is the time from the date of the first documented complete response or partial response until the date of the first date of progressive disease, or death due to any cause, whichever occurs first. If a patient has not progressed or died by the analysis cutoff date, duration of response will be censored at the time of the last adequate tumor assessment on or before the cutoff date.
  • Progression Free Survival [ Time Frame: Up to 12 weeks post treatment ]
    Progression free survival defined as the time from the start of study treatment until the first date of progressive disease, or death due to any cause, whichever occurs first. If a patient has not progressed or died by the analysis cutoff date, progression free survival will be censored at the time of the last adequate tumor assessment on or before the cutoff date.
  • Overall Survival [ Time Frame: Up to 5 years post treatment ]
    Overall survival is measured from the start of study treatment until death due to any cause. If a patient is not known to have died at the date of the analysis cut-off, overall survival will be censored at the last date that: Patient is documented to be alive. At the time of single cell sequencing.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsed T-Cell Lymphoma
  • Refractory T-Cell Lymphoma
  • Non Hodgkin Lymphoma
Intervention  ICMJE
  • Drug: CPI 613
    CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
    Other Name: devimistat
  • Drug: Bendamustine
    Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
    Other Names:
    • Bendeka
    • Treanda
    • Bendamustine Hydrochloride
Study Arms  ICMJE Experimental: CPI-613 in Combination with Bendamustine
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.
Interventions:
  • Drug: CPI 613
  • Drug: Bendamustine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 31, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brittany Mabe, RN 336-716-5440 bmabe@wakehealth.edu
Contact: Tong Chen, RN tchen@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04217317
Other Study ID Numbers  ICMJE IRB00062873
WFBCCC 28419 ( Other Identifier: IRB - Wake Forest University Health Science )
P30CA012197 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Rakhee Vaidya, M.B.B.S. Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP