A Pilot Study of Oncaspar® + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT01878708|
Recruitment Status : Terminated (Slow accrual)
First Posted : June 17, 2013
Last Update Posted : March 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|T-Cell Lymphoma Relapsed T-Cell Lymphoma Refractory T-Cell Lymphoma||Drug: PEG-L-asparaginase Drug: Dexamethasone acetate||Early Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Oncaspar® + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
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: Dexamethasone acetate
-dexamethasone 40mg daily for 4 days with every cycle.
- 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. [ Time Frame: 1 year ]This will be assessed in both evaluable patients and in responders.
- Complete remission (CR) rate. [ Time Frame: 24 weeks ]This will be assessed both in the intent-to-treat and in the evaluable populations.
- Partial remission (PR) rate. [ Time Frame: 24 weeks ]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 ]
- Progressive disease (PD) rate. [ Time Frame: 24 weeks ]This will be assessed both in the intent-to-treat and in the evaluable populations.
- Stable disease (SD) rate. [ Time Frame: 24 weeks ]This will be assessed both in the intent-to-treat and in the evaluable populations.
- Overall survival [ Time Frame: 1 year ]This will be assessed in both evaluable patients and in responders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878708
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Phillippe Armand, MD||Dana-Farber Cancer Institute|