Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma

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).

* Disease responding or stable after most recent therapy (chemotherapy, MoAb)

4. Mantle cell lymphoma

* Disease responding or stable after most recent therapy (chemotherapy, MoAb)

* Relapsed after prior autologous SCT

6. Diffuse large cell lymphoma or other high-grade NHL, previously identified as CD19+

* Relapsed after prior 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

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

What this study is about