NCT00031980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

3.2 years

First QC Date

March 8, 2002

Last Update Submit

July 1, 2016

Conditions

AnemiaLeukemiaNeutropeniaThrombocytopenia

Keywords

stage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiaT-cell large granular lymphocyte leukemiaanemianeutropeniathrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Frequency of cytopemic response

    Up to 10 years

Study Arms (1)

cyclosporine

EXPERIMENTAL

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.

Drug: cyclosporine

Interventions

cyclosporineDRUG
cyclosporine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

AnemiaLeukemiaNeutropeniaThrombocytopeniaLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Large Granular Lymphocytic

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersBlood Platelet DisordersLeukemia, B-CellLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, T-Cell

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Maria R. Baer, MD

    University of Maryland Greenebaum Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

March 1, 2002

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

US(1)