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 @ 6:39 PM
Ignite Modification Date:
2025-12-24 @ 6:39 PM
NCT ID:
NCT01596257
Eligibility Criteria:
Inclusion Criteria:
* Patients who are considered candidates for an allogeneic stem cell transplantation as treatment for any of the following hematologic disorders:
* Acute Leukemia
* Myelodysplastic syndrome
* Other myeloproliferative disorder (i.e. myelofibrosis, chronic myelomonocytic leukemia, or chronic myelogenous leukemia)
* Non Hodgkins Lymphoma
* Hodgkins Disease
* Multiple Myeloma
* Age includes from birth to \< 75 years old.
* Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status \> 70%
* Patients must have adequate organ function measured by:
* Cardiac: asymptomatic or if symptomatic then LVEF at rest must be \> 40%
* Hepatic: \< 5x ULN ALT and \< 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
* Renal: serum creatinine \<1.5 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 40 ml/min (measured or calculated/estimated)
* Pulmonary: asymptomatic or if symptomatic, DLCO \> 40% of predicted (corrected for hemoglobin).
Exclusion Criteria:
* Female patients who are pregnant or breast-feeding.
* Active viral, bacterial or fungal infection
* Patient seropositive for HIV-I/II; HTLV -I/II
* Presence of leukemia in the CNS
* Candidate for a protocol of higher priority. For the purpose of this study, the following protocols will be considered of higher priority: 10-051
Donor Inclusion Criteria:
* HLA compatible related or unrelated donor, (i.e. a fully matched unmanipulated grafts or 1-2 HLA allele disparate donor for CD34 selected grafts).
* Meets criteria outlined in the FACT-approved SOP for "DONOR EVALUATION AND SELECTION FOR ALLOGENEIC TRANSPLANTATION" in the Blood and Marrow Transplant Program Manual, document E-1 see http://mskweb5.mskcc.org/intranet/html/80312.cfm
* Donor must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter.
* Wt \>25kg
Donor Exclusion Criteria:
* Evidence of active infection (including urinary tract infection, or upper respiratory tract Infection) or viral hepatitis exposure (on screening), unless only HBS Ab+ and HBV DNA negative.
* Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis.
* Factors which place the donor at increased risk for complications from leukapheresis or GCSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy).
* Pregnancy (positive serum or urine β-HCG) or breastfeeding. Women of childbearing age must avoid becoming pregnant while on the study
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT01596257
Study Brief:
Protocol Section:
NCT01596257