NCT00070291

Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma

A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma. PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.

Detailed description

OBJECTIVES: Primary * Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine. Secondary * Determine the disease-free, progression-free, and overall survival of patients treated with this drug. * Determine the toxicity of this drug in these patients. OUTLINE: Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6. Patients experiencing disease progression during weeks 7-36, receive an additional 36 weeks of therapy. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 2.5 years.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	cyclosporine	Cyclosporine doses will be based on actual body weight unless actual body weight is \> 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6, starting dose will begin at cyclosporine 3 mg/kg by mouth two times a day (PO BID)) and 150-250 ng/mL during the maintenance period (weeks 7-36, maintenance dose will begin at cyclosporine 2 mg/kg PO BID) in the absence of renal toxicity

Timeline

• Start date: 2006-01-24
• Primary completion: 2009-03-01
• Completion: 2011-05-01
• First posted: 2003-10-07
• Last updated: 2023-06-29
• Results posted: 2013-02-08

Locations

23 sites across 1 country: United States