AzTrials
AzTrials

T-Cell LymphomaEarly Phase 1NCT01878708

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

A Early Phase 1 study testing PEG-L-asparaginase and Dexamethasone acetate in people with T-Cell Lymphoma and Relapsed T-Cell Lymphoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
PEG-L-asparaginase and Dexamethasone acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
2 sitesUnited States
Study dates
Jul 2013to Feb 2017
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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.

Read the 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.

Being tested
PEG-L-asparaginase, Dexamethasone acetate
Keywords
T-Cell Lymphoma, Relapsed T-Cell Lymphoma, Refractory T-Cell Lymphoma, Oncaspar®, PEG-L-asparaginase and dexamethasone
Medical subject headings
Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG-L-asparaginaseDrug

    Also called Oncaspar, PEG-asparaginase

  • Dexamethasone acetateDrug

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

Study groups in NCT01878708
Study groupRoleWhat they receive
PEG-L-asparaginase/DexamethasoneExperimentalPatients 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.
Receives: Drug: PEG-L-asparaginase; Drug: Dexamethasone acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 weeks

Secondary outcomes (9)

  1. Duration of response for patients with PR or CR

    Measured: 24 weeks

  2. Grade 2 and above attributable toxicity of treatment.

    Measured: 24 weeks

  3. Progression-free survival.

    This will be assessed in both evaluable patients and in responders.

    Measured: 1 year

  4. Complete remission (CR) rate.

    This will be assessed both in the intent-to-treat and in the evaluable populations.

    Measured: 24 weeks

  5. Partial remission (PR) rate.

    This will be assessed both in the intent-to-treat and in the evaluable populations.

    Measured: 24 weeks

  6. The stable disease (SD) rates in this population and in the intent-to-treat population

    Measured: 24 weeks

  7. Progressive disease (PD) rate.

    This will be assessed both in the intent-to-treat and in the evaluable populations.

    Measured: 24 weeks

  8. Stable disease (SD) rate.

    This will be assessed both in the intent-to-treat and in the evaluable populations.

    Measured: 24 weeks

  9. Overall survival

    This will be assessed in both evaluable patients and in responders.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Why it stopped: Slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01878708
Sponsor's protocol ID
13-165
Status last verified
Mar 2017
First submitted
23 May 2013
Last updated
6 Mar 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing PEG-L-asparaginase and Dexamethasone acetate in people with T-Cell Lymphoma and Relapsed T-Cell Lymphoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (complete + partial response) in evaluable patients. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01878708.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in