A Pilot Study of Oncaspar® + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma

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Brief Title

A Pilot Study of Oncaspar® + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma

Official Title

A Pilot Study of Oncaspar® + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma

Brief Summary

      This is an open-label, single-arm pilot study of Oncaspar® with dexamethasone for patients
      with relapsed or refractory peripheral T-cell lymphoma (PTCL), excluding extranodal NK/T cell
      lymphoma (ENKTL). Patients will receive up to 8 courses of treatment.
    

Detailed Description

      This is an open-label, investigator-initiated, single-arm pilot study. Patients with relapsed
      or refractory (R/R) peripheral T-cell lymphoma (PTCL) will receive Oncaspar® every 3 weeks up
      to a maximum of 8 courses or until disease progression or unacceptable toxicity. They will
      also receive dexamethasone 40mg daily for 4 days with every cycle. They will be restaged
      after 2 courses (6 weeks) and after 8 courses (24 weeks).

      Both Oncaspar and dexamethasone have been used together to treat ALL and ENKTL, which is
      another subtype of T cell lymphoma. The combination may provide a collaborative attack
      against the cancer cell; moreover, the dexamethasone could also prevent some of the side
      effects of Oncaspar; especially allergic reactions. This study will test these two drugs
      together to determine if they are an effective treatment for T-Cell Lymphoma. Each drug is
      commercially available to the drug market.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Overall response rate (complete + partial response) in evaluable patients.

Secondary Outcome

 Duration of response for patients with PR or CR

Condition

T-Cell Lymphoma

Intervention

PEG-L-asparaginase

Study Arms / Comparison Groups

 PEG-L-asparaginase/Dexamethasone
Description:  Patients will receive Oncaspar® (PEG-asparaginase) at a dose of 2,000 IU/m2 administered intramuscularly on day 3 of each 3 week cycle, with dexamethasone 40mg given orally on days 1-4.

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

2

Start Date

July 2013

Completion Date

February 2017

Primary Completion Date

February 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must meet the following criteria on screening examination to be eligible to
             participate in the study:

          -  Patients must have histologically confirmed peripheral T-cell lymphoma, with the
             diagnostic specimen reviewed at one of the DFHCC hematopathology laboratories.
             Eligible histologies include:

          -  PTCL-NOS

          -  Systemic T cell/null anaplastic large cell lymphoma (ALCL), regardless of Alk status

          -  Angioimmunoblastic T-cell lymphoma (AITL)

          -  Hepatosplenic (alpha-beta or gamma-delta) lymphoma (HSL)

          -  Enteropathy-associated T-cell lymphoma (EATL)

          -  Adult T-cell leukemia/lymphoma (ATLL), lymphomatous subtype

          -  Subcutaneous panniculitis-like T-cell lymphoma

          -  T-cell Prolymphocytic Leukemia (T-PLL)

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >
             20 mm with conventional techniques or as > 10 mm with spiral CT scan

          -  Patients must have relapsed or progressed after at least 1 prior course of
             anti-lymphoma therapy.

          -  Age 18-65 years.

          -  ECOG performance status <2 (see Appendix A).

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Patients who exhibit any of the following conditions at screening will not be eligible
             for admission into the study.

          -  Patients with cutaneous disease only are not eligible.

          -  Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events due to agents administered more than 3 weeks earlier to
             grade 1 or below (unless approved by the Study Chair).

          -  Patients may not be receiving any other study agents at the time of first treatment.

          -  History of treatment with an asparaginase agent.

          -  Patients with a history of alcohol abuse, or patients unwilling or unable to remain
             completely abstinent of alcohol during the study period.

          -  Hepatitis B or C seropositivity (except for hepatitis B with negative surface antigen
             and hepatitis B viral load).

          -  Total bilirubin > institutional upper limit of normal (ULN), unless due to hemolysis
             or Gilbert's disease).

          -  AST/ALT ≥ 3 x ULN.

          -  History of pancreatitis, or amylase > ULN or lipase > ULN.

          -  History of thromboembolic disease.

          -  Grade 2 or above neuropathy.

          -  Diabetes mellitus, unless it is type II diabetes adequately controlled with
             anti-diabetic agents (A1c < 7).

          -  History of CNS hemorrhage or thrombosis. Patients with a history of CNS lymphomatous
             involvement are eligible only if their CNS disease is in remission at the time of
             study entry.

          -  Uncontrolled intercurrent illness including, but not limited to uncontrolled active
             infection, symptomatic congestive heart failure (New York Hospital Association (NYHA)
             class II-IV, resulting in at least slight limitation of activity), unstable angina
             pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
             limit compliance with study requirements.

          -  Inability to provide informed consent

          -  Pregnancy or lactation.

          -  Individuals with a history of a different malignancy are ineligible except for the
             following circumstances. Individuals with a history of other malignancies are eligible
             if they have been disease-free for at least 3 years and are deemed by the investigator
             to be at low risk for recurrence of that malignancy. Individuals with the following
             cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer
             in situ, and basal cell or squamous cell carcinoma of the skin.

          -  HIV-positive individuals on combination antiretroviral therapy are ineligible.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Phillippe Armand, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01878708

Organization ID

13-165


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Leadiant Biosciences, Inc.

Study Sponsor

Phillippe Armand, MD, Principal Investigator, Dana-Farber Cancer Institute


Verification Date

March 2017