NCT01878708

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• T-Cell Lymphoma
• Relapsed T-Cell Lymphoma
• Refractory T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	PEG-L-asparaginase
DRUG	Dexamethasone acetate	-dexamethasone 40mg daily for 4 days with every cycle.

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2013-06-17
• Last updated: 2017-03-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study