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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT00810602
Eligibility Criteria:
Inclusion Criteria:
* Have a 7/8 or 8/8 HLA A, B, C and DR, HLA-matched related donor willing and able to donate allogeneic stem cells.
* For patients with multiple myeloma, CLL, and lymphoma: must be in CR, PR, or stable disease.
* For MDS, acute leukemia or CML: must have \<20% blasts on marrow exam.
* For all other diseases: must have non-refractory disease.
and meet at least ONE of the next three criteria:
* Any patient ≥ 18 years of age with a hematological malignancy and not considered a candidate for allogeneic myeloablative transplant due to illness and/or age (≥55 years).
* Any patient ≥ 18 years of age who has relapsed following prior autologous or allogeneic transplant for a hematologic malignancy.
* Any patient ≥ 18 years of age diagnosed with a hematological malignancy for which reduced intensity transplant is institutionally preferred over myeloablative transplant (eg, chronic lymphocytic leukemia).
Exclusion Criteria:
* Less than 18 years of age.
* Currently taking any HDAC inhibitors, or have taken an HDAC inhibitor within 30 days of the trial.
* Positive serum tests for HIV, HTLV1 / HTLV2.
* Detectable hepatitis B virus (HBV), hepatitis C (HCV) or Epstein-Barr (EBV).
* Pregnancy.
* One or more of the following organ system function criteria
* Cardiac: Ejection fraction ≤ 40%
* Renal: Estimated or actual GFR ≤ 40 ml/min (corrected for BSA)
* Pulmonary: FEV1, FVC, or DLCO ≤ 40% predicted
* Hepatic: Total bilirubin ≥3 mg% and AST/ALT \>5 x institutional normal for age
* Karnofsky score ≤50 (Requires considerable assistance and frequent medical care).
* Persistent invasive infections not controlled by antimicrobial medication.
* Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00810602
Study Brief:
Protocol Section:
NCT00810602