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

Primary Purpose

Anemia, Leukemia, Neutropenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cyclosporine
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anemia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cyclosporine

Arm Description

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.

Outcomes

Primary Outcome Measures

Frequency of cytopemic response

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
July 1, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00031980
Brief Title
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cyclosporine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Primary Outcome Measure Information:
Title
Frequency of cytopemic response
Time Frame
Up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria R. Baer, MD
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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

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