Clinical trial NCT00031980: Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer
Official title: Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Leukemia
Neutropenia
Thrombocytopenia
Keywords: stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
T-cell large granular lymphocyte leukemia
anemia
neutropenia
thrombocytopenia
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Cyclosporine may improve low blood counts caused by hematologic cancer.

PURPOSE: Phase II trial to study the effectiveness of cyclosporine in treating patients who have low blood counts caused by hematologic cancer.

Detailed description: OBJECTIVES:

* Determine the frequency of cytopenic response in patients with T-cell large granular lymphocytic leukemia treated with cyclosporine.

OUTLINE: This is a multicenter study.

Patients receive oral cyclosporine every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 4 months for 1 year and then every 6 months for 9 years.

PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 3 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of T-cell large granular lymphocytic leukemia

  * Increased numbers of large granular lymphocytes in peripheral blood smears
  * CD3+CD8+CD57+ immunophenotype by flow cytometry AND
  * CD3+CD57+ cell count at least 2,000/mm\^3 OR
  * CD3+CD57+ cell count at least 500/mm\^3 with clonal T-cell receptor beta gene rearrangement
* Patients must have at least 1 of the following:

  * Severe neutropenia (absolute neutrophil count (ANC) less than 500/mm\^3)
  * Neutropenia (ANC less than 1,000/mm\^3) and recurrent infections
  * Anemia (hemoglobin less than 9 g/dL)
  * Thrombocytopenia (platelet count less than 50,000/mm\^3)

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* NCI CTC 0-3

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 2 times ULN

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Endocrine therapy:

* No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)
* No concurrent dexamethasone or other steroidal antiemetics

Other:

* No prior cyclosporine therapy for this leukemia

Primary outcomes:
measure: Frequency of cytopemic response
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: University of Maryland Greenebaum Cancer Center
name: Maria R. Baer, MD
role: STUDY_CHAIR
References: