AnemiaPhase 2NCT00031980
Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer
A Phase 2 study testing cyclosporine in people with Anemia and Leukemia, run by Alliance for Clinical Trials in Oncology at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Leukemia, Neutropenia
- What is being tested?
- cyclosporine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to May 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia
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.
Read the 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
- Being tested
- cyclosporine
- 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
- Medical subject headings
- Anemia, Leukemia, Neutropenia, Thrombocytopenia, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Large Granular Lymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporineDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of cytopemic response
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2002
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Maria R. Baer, MD, Study chair, University of Maryland Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031980
- Sponsor's protocol ID
- CALGB-10003
- Other IDs
- CALGB-10003, CDR0000069246
- Status last verified
- Jul 2016
- First submitted
- 8 Mar 2002
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00031980
- Acronym / sponsor ID
- CALGB-10003
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2002
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cyclosporine | Experimental | Drug: cyclosporinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cyclosporine | Drug | cyclosporine |
Primary outcome
Frequency of cytopemic response
Time frame: Up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria R. Baer, MD study chair
University of Maryland Greenebaum Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyclosporine in people with Anemia and Leukemia, run by Alliance for Clinical Trials in Oncology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of cytopemic response (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.