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Clinical Trials/PER-143-08
PER-143-08
Completed
未知

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

EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),0 sites0 target enrollmentMarch 9, 2009

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 9, 2009
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Not specified

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