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

Stopped early · Phase 2

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT00070291

Run by

Eastern Cooperative Oncology Group

People needed

4

Starts

2006-01-24

Expected to finish

2011-05-01

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination.
• At least one objective measurable or evaluable disease parameter.
• Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. Patients may not receive concurrent chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Adequate renal function as indicated by creatinine <= 1.5 the upper limit of normal (ULN).
• Adequate liver function as indicated by alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 2x the upper limit of normal.
• Total bilirubin <= 2x the upper limit of normal.
• Age 18 or older.

You may not qualify if…

• Prior cyclosporine or Tacrolimus (FK506).
• Prior allogeneic transplant.
• Evidence of active infection.
• Congestive heart failure, kidney failure, liver failure, or other severe co-morbidities.
• Evidence of active neurological impairment.
• Previous history of hypersensitivity to cyclosporine and/or Cremorphor EL (polyoxyethylated oil).
• History of other malignancies (other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin).
• pregnant or breastfeeding women.
• Human immunodeficiency virus (HIV) positive.

Where it is running

• Stanford Cancer Center — Stanford, California, United States
• Rush-Copley Cancer Care Center — Aurora, Illinois, United States
• Hematology Oncology Associates of Illinois - Berwyn — Berwyn, Illinois, United States
• Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
• Hematology and Oncology Associates — Chicago, Illinois, United States
• Saint Joseph Hospital — Chicago, Illinois, United States
• Midwest Center for Hematology/Oncology — Joliet, Illinois, United States
• Joliet Oncology-Hematology Associates, Limited - West — Joliet, Illinois, United States
• North Shore Oncology and Hematology Associates, Limited - Libertyville — Libertyville, Illinois, United States
• La Grange Oncology Associates - Geneva — Naperville, Illinois, United States
• Cancer Care and Hematology Specialists of Chicagoland - Niles — Niles, Illinois, United States
• Hematology Oncology Associates - Skokie — Skokie, Illinois, United States
• Carle Cancer Center at Carle Foundation Hospital — Urbana, Illinois, United States
• CCOP - Carle Cancer Center — Urbana, Illinois, United States
• Saint Anthony Memorial Health Centers — Michigan City, Indiana, United States
• Siouxland Hematology-Oncology Associates, LLP — Sioux City, Iowa, United States
• Mercy Medical Center - Sioux City — Sioux City, Iowa, United States
• St. Luke's Regional Medical Center — Sioux City, Iowa, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Borgess Medical Center — Kalamazoo, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Bronson Methodist Hospital — Kalamazoo, Michigan, United States
• St. Rita's Medical Center — Lima, Ohio, United States

Full record on ClinicalTrials.gov

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