NCT01878708

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jul 2013

Typical duration for early_phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 6, 2017

Status Verified

March 1, 2017

Enrollment Period

3.6 years

First QC Date

May 23, 2013

Last Update Submit

March 2, 2017

Conditions

T-Cell LymphomaRelapsed T-Cell LymphomaRefractory T-Cell Lymphoma

Keywords

T-Cell LymphomaRelapsed T-Cell LymphomaRefractory T-Cell LymphomaOncaspar®PEG-L-asparaginase and dexamethasone

Outcome Measures

Primary Outcomes (1)

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

    24 weeks

Secondary Outcomes (9)

  • Duration of response for patients with PR or CR

    24 weeks

  • Grade 2 and above attributable toxicity of treatment.

    24 weeks

  • Progression-free survival.

    1 year

  • Complete remission (CR) rate.

    24 weeks

  • Partial remission (PR) rate.

    24 weeks

  • +4 more secondary outcomes

Study Arms (1)

PEG-L-asparaginase/Dexamethasone

EXPERIMENTAL

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-asparaginaseDrug: Dexamethasone acetate

Interventions

PEG-L-asparaginaseDRUG
Also known as: Oncaspar, PEG-asparaginase
PEG-L-asparaginase/Dexamethasone
Dexamethasone acetateDRUG

-dexamethasone 40mg daily for 4 days with every cycle.

PEG-L-asparaginase/Dexamethasone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

pegaspargasedexamethasone acetate

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Phillippe Armand, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2013

First Posted

June 17, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 6, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)