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 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT01626495
Eligibility Criteria:
Inclusion Criteria:
Male and female subjects with CD 19+ 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:
1. Eligible diseases: CD 19+ leukemia or lymphoma
1. ALL without curative options for therapy, including those not eligible for allogeneic
SCT because of:
* age
* co-morbid disease
* other contraindications to TBI-based conditioning (required for ALL SCT)
* lack of suitable donor
* prior SCT
* Declines allo SCT (in CR3) as a therapeutic option after documented discussion about the role of SCT with a BMT physician not part of the study team. Note: Patient may be in any complete response, or patient may have active disease but responding or stable after most recent therapy. The intent is not to enroll patients with no degree of disease control, or rapidly increasing disease burden between enrollment and cell infusion.
2. 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).
3. CLL
* At least 2 prior chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy.
* Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \<1 year).
* Not eligible or appropriate for conventional allogeneic SCT
* Disease responding or stable after most recent therapy (chemotherapy, MoAb)
4. 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)
* Relapsed after prior autologous SCT
5. B-cell prolymphocytic leukemia (PLL) with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
6. Diffuse large cell lymphoma or other high-grade NHL, 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 for conventional allogeneic or autologous SCT
2. Age 1 to 24 years. Patients ages 22-24 will only be enrolled if they are currently being treated at CHOP or another pediatric facility/oncologist
3. Expected survival \> 12 weeks
4. Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
5. ALT ≤ 5x normal
6. Bilirubin \<2.0 mg/dl
7. Any relapse after prior SCT will make patient eligible regardless of other prior therapy
8. Patients with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and
1. Have no active GVHD and require no immunosuppression
2. Are more than 4 months from transplant
9. For those patients who require leukapheresis for T cell collection (i.e. no previously collected product exists), adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis
10. Voluntary informed consent is given
11. Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy (at infusion)
Exclusion Criteria:
1. 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
2. Uncontrolled active infection
3. Active hepatitis B or hepatitis C infection
4. Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of inhaled steroids, or hydrocortisone for physiological replacement in patients with adrenal insufficiency are permitted as well
5. Presence of grade 2-4 acute or extensive chronic GVHD
6. Under treatment for GVHD
7. Previous treatment with any gene therapy products
8. Any uncontrolled active medical disorder that would preclude participation as outlined.
9. HIV infection.
10. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
24 Years
Study:
NCT01626495
Study Brief:
Protocol Section:
NCT01626495