Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer

Leukemia Clinical Trial

Official title:

Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031980
• Other study ID #: CALGB-10003
• Secondary ID: CALGB-10003CDR00
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2002
• Last updated: July 1, 2016
• Start date: March 2002
• Est. completion date: May 2005

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia
• Leukemia
• Leukemia, Lymphoid
• Neutropenia
• Thrombocytopenia

Intervention

Drug:
• cyclosporine

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of cytopemic response		Up to 10 years	No