Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma
Completed · Phase 1/Phase 2
Conditions studied: B Cell Leukemia, B Cell Lymphoma
In brief
This is a study for children who have been previously treated for Leukemia/Lymphoma. In particular, it is a study for people who have a type of Leukemia/Lymphoma that involves B cells (a type of white cell), which contain the cancer. This is a new approach for treatment of Leukemia/Lymphoma that involves B cells (tumor cells). This study will take the subject's white blood cells (T cells) and modify them in order to target the cancer. The subject's T cells will be modified in one or two different ways that will allow the cells to identify and kill the tumor cells (B cells). Both ways of modifying the cells tells the T cells to go to the B cells (tumor cells) and turn "on" and potentially kill the B cells (tumor cells). The modification is a genetic change to the T cells, or gene transfer, in order to allow the modified T cells to recognize your tumor cells but not other normal cells in the subject's body. These modified cells are called chimeric antigen receptor 19 (CART19) T-cells.
Key facts
- Study ID
- NCT01626495
- Run by
- University of Pennsylvania
- People needed
- 73
- Starts
- 2011-08-17
- Expected to finish
- 2019-07-11
- Last updated by the study team
- 2020-03-23
Who can join
Age: 1 and older, up to 24. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Eligible diseases: CD 19+ leukemia or lymphoma
- 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.
- 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).
- 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)
- 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
- B-cell prolymphocytic leukemia (PLL) with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
You may not qualify if…
- 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 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
- Presence of grade 2-4 acute or extensive chronic GVHD
- Under treatment for GVHD
- Previous treatment with any gene therapy products
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- HIV infection.
- CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity
Where it is running
- CHOP - http://www.chop.edu/service/oncology/pediatric-cancer-research/cart-19-trial.html — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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