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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
-dexamethasone 40mg daily for 4 days with every cycle.
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Overall response rate (complete + partial response) in evaluable patients.
Time frame: 24 weeks
Duration of response for patients with PR or CR
Time frame: 24 weeks
Grade 2 and above attributable toxicity of treatment.
Time frame: 24 weeks
Progression-free survival.
This will be assessed in both evaluable patients and in responders.
Time frame: 1 year
Complete remission (CR) rate.
This will be assessed both in the intent-to-treat and in the evaluable populations.
Time frame: 24 weeks
Partial remission (PR) rate.
This will be assessed both in the intent-to-treat and in the evaluable populations.
Time frame: 24 weeks
The stable disease (SD) rates in this population and in the intent-to-treat population
Time frame: 24 weeks
Progressive disease (PD) rate.
This will be assessed both in the intent-to-treat and in the evaluable populations.
Time frame: 24 weeks
Stable disease (SD) rate.
This will be assessed both in the intent-to-treat and in the evaluable populations.
Time frame: 24 weeks
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Overall survival
This will be assessed in both evaluable patients and in responders.
Time frame: 1 year