Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT00005967
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed hematologic malignancy refractory to standard therapy or for which no known effective therapy exists
* Hodgkin's or non-Hodgkin's lymphoma
* Known bone marrow involvement
* Acute myeloid leukemia
* Chronic myelogenous leukemia
* Chronic phase
* No significant symptoms after treatment
* No features of accelerated phase or blastic phase
* Accelerated phase
* WBC difficult to control with conventional busulfan or hydroxyurea in terms of dose requirement or shortening of intervals between courses
* Rapid doubling of WBC (less than 5 days)
* At least 10% blasts in blood or marrow
* At least 20% blasts plus promyelocytes in blood or marrow
* At least 20% basophils plus eosinophils in blood
* Anemia or thrombocytopenia unresponsive to busulfan or hydroxyurea
* Persistent thrombocytosis
* Additional chromosome changes
* Increasing splenomegaly
* Development of chloromas or myelofibrosis
* Blastic phase
* At least 30% blasts plus promyelocytes in blood or bone marrow
* Acute lymphoblastic leukemia
* Chronic lymphocytic leukemia
* Myelodysplastic syndromes
* Refractory anemia with excess blasts (RAEB)
* Chronic myelomonocytic leukemia
* RAEB in transformation
* Multiple myeloma
* Chronic myeloproliferative diseases including, but not limited to, myelofibrosis with myeloid metaplasia
* Measurable or evaluable disease documented by radiographic, hematologic, bone marrow, or clinical examination parameters
* Refusal of allogeneic bone marrow transplantation allowed
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* Albumin at least 2.5 g/dL
Renal:
* Creatinine less than 2.0 mg/dL
Other:
* No other uncontrolled medical disorder
* No active inflammatory bowel disease, ileus, or other chronic malabsorption syndromes
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 2 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
* At least 3 days since prior hydroxyurea
Endocrine therapy:
* At least 4 weeks since prior systemic steroids for multiple myeloma
Radiotherapy:
* At least 4 weeks since prior radiotherapy
Surgery:
* No prior total gastrectomy or total ileocolectomy
Other:
* No prior tipifarnib
* No concurrent proton pump inhibitors (e.g., omeprazole)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00005967
Study Brief:
Protocol Section:
NCT00005967