Clinical trial · Interventional
Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer
Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia
NCT00031980CI-TRIAL-00022899completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Neutropenia | — | UNRESOLVED | — |
| Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclosporine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cyclosporine
- 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.
- interventionNames
- Drug: cyclosporine
Primary outcomes (1)
- measure
- Frequency of cytopemic response
- timeFrame
- Up to 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.