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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT01864902
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects with CD33+ acute myeloid leukemia in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled
* CD33+ acute myeloid leukemia CR can not be achieved after at least 2 prior combination chemotherapy regimens.
AML in CR(complete remission)2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor.
Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year).
Relapsed after prior autologous or allogenic SCT. AML patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
Residual disease after primary therapy and not eligible for autologous SCT
* Expected survival \> 12 weeks
* Creatinine \< 2.5 mg/dl
* ALT(alanine aminotransferase)/AST (aspartate aminotransferase)\< 3x normal
* Bilirubin \< 2.0 mg/dl
* Any relapse after prior SCT will make patient eligible regardless of other prior therapy
* Adequate venous access for apheresis, and no other contraindications for leukapheresis
* Voluntary informed consent is given
Exclusion Criteria:
* Pregnant or lactating women
* The safety of this therapy on unborn children is not known
* Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
* Uncontrolled active infection
* Active hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
* Previously treatment with any gene therapy products
* Feasibility assessment during screening demonstrates \< 30% transduction of target lymphocytes, or insufficient expansion (\< 5-fold) in response to CD3/CD137 costimulation
* Any uncontrolled active medical disorder that would preclude participation as outlined
* HIV infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
90 Years
Study:
NCT01864902
Study Brief:
Protocol Section:
NCT01864902