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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT01029366
Eligibility Criteria:
Inclusion
* Male and female subjects with CD19+ B cell malignancies 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
* CD19+ leukemia or lymphoma
* ALL in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor
* Follicular lymphoma, previously identified as CD19+:
* At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy
* Stage III-IV disease
* Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year)
* Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
* CLL:
* At least 2 prior chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy. Patients with high risk disease manifested by deletion chromosome 17p will be eligible if they fail to achieve a CR to initial therapy or progress within 2 years of 1 prior
* Less than 2 years between last chemotherapy and progression (i.e. most recent progression free interval \< 2 years)
* Not eligible or appropriate for conventional allogeneic SCT
* Patients who achieve only a partial response to FCR as initial therapy will be eligible.
* Mantle cell lymphoma:
* Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT
* Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc...)
* Relapsed after prior autologous SCT
* B-cell prolymphocytic leukemia (PLL) with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT
* Diffuse large cell lymphoma, previously identified as CD19+:
* Residual disease after primary therapy and not eligible for autologous SCT
* Relapsed after prior autologous SCT
* Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate of conventional allogeneic or autologous SCT
* Expected survival \> 12 weeks
* Creatinine \< 2.5 mg/dl
* ALT/AST \< 3x normal
* Bilirubin \< 2.0 mg/dl
* Any relapse after prior autologous 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
* 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/CD28 costimulation
* Any uncontrolled active medical disorder that would preclude participation as outlined
* HIV infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01029366
Study Brief:
Protocol Section:
NCT01029366