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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Dana-Farber Cancer Institute
Sponsor:
Collaborator:
Sigma Tau Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Philippe Armand, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01878708
First received: May 23, 2013
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
T-Cell Lymphoma
Relapsed T-Cell Lymphoma
Refractory T-Cell Lymphoma
Drug: PEG-L-asparaginase
Drug: Dexamethasone acetate
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Oncaspar® + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Overall response rate (complete + partial response) in evaluable patients. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response for patients with PR or CR [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Grade 2 and above attributable toxicity of treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Progression-free survival. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    This will be assessed in both evaluable patients and in responders.

  • Complete remission (CR) rate. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    This will be assessed both in the intent-to-treat and in the evaluable populations.

  • Partial remission (PR) rate. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    This will be assessed both in the intent-to-treat and in the evaluable populations.

  • The stable disease (SD) rates in this population and in the intent-to-treat population [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Progressive disease (PD) rate. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    This will be assessed both in the intent-to-treat and in the evaluable populations.

  • Stable disease (SD) rate. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    This will be assessed both in the intent-to-treat and in the evaluable populations.

  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    This will be assessed in both evaluable patients and in responders.


Estimated Enrollment: 11
Study Start Date: July 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG-L-asparaginase
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.
Drug: PEG-L-asparaginase
Other Names:
  • Oncaspar
  • PEG-asparaginase
Drug: Dexamethasone acetate
-dexamethasone 40mg daily for 4 days with every cycle.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878708

Contacts
Contact: Philippe Armand, MD (617) 632-2305 PARMAND@PARTNERS.ORG

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Phillippe Armand, MD    617-632-2305    PARMAND@PARTNERS.ORG   
Principal Investigator: Phillippe Armand, MD         
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeremy Abramson, MD    617-726-8743    jabramson@partners.org   
Principal Investigator: Jeremy Abramson, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Sigma Tau Pharmaceuticals, Inc.
Investigators
Principal Investigator: Phillippe Armand, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Philippe Armand, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01878708     History of Changes
Other Study ID Numbers: 13-165
Study First Received: May 23, 2013
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
T-Cell Lymphoma
Relapsed T-Cell Lymphoma
Refractory T-Cell Lymphoma
Oncaspar®
PEG-L-asparaginase and dexamethasone

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Pegaspargase
Asparaginase
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014