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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate (Complete and Partial Response)

Outcome Description:

Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of > 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.

Outcome Time Frame:

Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up.

Safety Issue:

No

Principal Investigator

Ranjana Advani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

CDR0000331864

NCT ID:

NCT00070291

Start Date:

September 2005

Completion Date:

May 2011

Related Keywords:

  • Lymphoma
  • angioimmunoblastic T-cell lymphoma
  • Immunoblastic Lymphadenopathy
  • Lymphoma
  • Lymphoma, T-Cell

Name

Location

CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
St. Rita's Medical CenterLima, Ohio  45801
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
Hematology and Oncology AssociatesChicago, Illinois  60611
Midwest Center for Hematology/OncologyJoliet, Illinois  60432
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
Stanford Cancer CenterStanford, California  94305-5824
Hematology Oncology Associates of Illinois - BerwynBerwyn, Illinois  60402
Saint Joseph HospitalChicago, Illinois  60657
La Grange Oncology Associates - GenevaNaperville, Illinois  60563
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714