Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	ECOG-2402 NCT00070291, E2402

Objectives

Primary

1. Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.

Secondary

1. Determine the disease-free, progression-free, and overall survival of patients treated with this drug.
2. Determine the toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed angioimmunoblastic T-cell lymphoma
  • Recurrent or refractory disease



• At least 1 measurable or evaluable disease parameter
  • Biopsy-proven skin disease alone may constitute evaluable disease
  • Constitutional symptoms and evidence of hemolysis alone do not constitute evaluable disease



• Failed at least 1 type of prior treatment (i.e., chemotherapy, autologous transplantation, or steroid treatment)

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• No prior allogeneic transplantation

Chemotherapy

• See Disease Characteristics
• No concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• Concurrent steroids allowed, but taper must be planned with goal of no steroids by week 3 of study treatment

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior cyclosporine
• No prior tacrolimus
• No concurrent allopurinol

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No liver failure
• Alkaline phosphatase no greater than 2 times upper limit of normal (ULN)
• AST and ALT no greater than 2 times ULN
• Bilirubin no greater than 2 times ULN
  • If total bilirubin is elevated, bilirubin should be fractionated and direct bilirubin must be normal

Renal

• No kidney failure
• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No congestive heart failure

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No history of hypersensitivity to cyclosporine and/or Cremophor EL (polyoxyethylated oil)
• No history of other malignancy except cured carcinoma in situ of the cervix or basal cell skin cancer
• No evidence of active infection
• No evidence of active neurological impairment
• No other severe comorbidity

Expected Enrollment

A total of 27 patients will be accrued for this study within 2.5 years.

Outcomes

Response rate (complete and partial response)

Toxicity
Disease-free survival
Progression-free survival
Overall survival

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Ranjana Advani, MD, Protocol chair		Ph: 650-724-8372; 800-756-9000
Sandra Horning, MD, Protocol co-chair		Ph: 650-725-6456; 800-756-9000

Registry Information
Official Title		A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma
Trial Start Date		2005-09-06
Trial Completion Date		2017-11-25 (estimated)
Registered in ClinicalTrials.gov		NCT00070291
Date Submitted to PDQ		2003-08-25
Information Last Verified		2009-03-24
NCI Grant/Contract Number		CA21115

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