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

NCT ID: NCT00031980

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2005-05-31

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.

Conditions

Anemia; Leukemia; Neutropenia; Thrombocytopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

cyclosporine

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.

Group Type: EXPERIMENTAL

cyclosporine

Intervention Type: DRUG

Interventions

cyclosporine

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria R. Baer, MD

Role: STUDY_CHAIR

University of Maryland Greenebaum Cancer Center

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

CALGB-10003

Identifier Type: -

Identifier Source: secondary_id

CDR0000069246

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-10003

Identifier Type: -

Identifier Source: org_study_id