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:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT00891592
Eligibility Criteria:
Inclusion Criteria.
* Relapsed or persistent advanced hematologic malignancy; incurable with standard chemotherapy and eligible for allogeneic HSCT, including:
* CHRONIC MYELOGENOUS LEUKEMIA (CML). Subjects in accelerated or blast phase or subjects in chronic phase with inadequate response to Imatinib or intolerant to Imatinib.
* ACUTE MYELOGENOUS LEUKEMIA (AML). Subject with high risk disease in first complete remission (CR). High risk disease includes the following cytogenetic abnormalities: monosomy 7, deletion 5, trisomy 8, inversion 3, t(3;3), t(6;9), or t(6;11). Subjects with complex cytogenetic abnormalities (more than 3 chromosomal abnormalities).
* ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects with diagnosis of AML after receiving chemotherapy, radiation therapy or biopsy showing myelodysplastic syndrome.
* ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects with persistent AML after 2 cycles of standard induction chemotherapy.
* ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects in first complete remission.
* MYELODYSPLASTIC SYNDROME (MDS). Subjects with intermediate or high risk disease based upon International Prognostic Scoring System.
* ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). Subjects with Philadelphia Chromosome (have t(9;22) cytogenetic abnormality) or molecular documentation for BCR-ABL translocation.
* ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). Subjects with primary refractory disease or subjects in 1st complete remission.
* NHL or HODKIN'S DISEASE. Subjects who relapse following autologous Stem Cell Transplant.
* INDOLENT NHL. Subjects with progressive disease following \> 2 regimens.
* MULTIPLE MYELOMA. Subjects who relapse following following autologous Stem Cell Transplant.
* Adults age 21-50.
* Expected survival 4 weeks.
* Subjects with no suitable related or unrelated donor for Stem Cell Transplant.
* Subject has suitable Umbilical Cord Blood (UCB) unit available.
* Subject has: Ejection fraction \> 45%; DLCO.45% predicted; Creatinine \< 2; Total bilirubin \< 2X normal; Transaminases \< 2X normal.
* Subject is capable of giving informed consent.
Exclusion Criteria:
* Subject is pregnant or lactating.
* Subject has an uncontrolled infection.
* Subject has an active or untreated disease involving the central nervous system.
* Subject has an active or uncontrolled medical condition that would preclude participation in the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT00891592
Study Brief:
Protocol Section:
NCT00891592