Gender | B-Cell Leukemia CD19 Positive | Curative treatment Unavailable | Transplantation of autologous hematopoietic stem cell Unavailable | Allogeneic Stem Cell Transplantation Unavailable | Prognosis Limited | Therapy Available | Life Expectancy
Item
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:
boolean
C0079399 (UMLS CUI [1])
C2004493 (UMLS CUI [2,1])
C4289895 (UMLS CUI [2,2])
C1273390 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C1831743 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
C2242529 (UMLS CUI [5,1])
C0686905 (UMLS CUI [5,2])
C0033325 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0087111 (UMLS CUI [7,1])
C0470187 (UMLS CUI [7,2])
C0023671 (UMLS CUI [8])
Leukemia CD19 Positive | Lymphoma CD19 Positive
Item
1. eligible diseases: cd19+ leukemia or lymphoma
boolean
C0023418 (UMLS CUI [1,1])
C4289895 (UMLS CUI [1,2])
C0024299 (UMLS CUI [2,1])
C4289895 (UMLS CUI [2,2])
Acute lymphocytic leukemia | Curative treatment Absent | Ineligibility Allogeneic Stem Cell Transplantation | Etiology aspects | Age | Comorbidity | Medical contraindication | Donor Suitable Lacking | Stem cell transplant Previous | Allogeneic Hematopoietic Stem Cell Transplantation Rejected
Item
a. all without curative options for therapy, including those not eligible for allogeneic sct because of: i. age ii. comorbid disease iii. other contraindications to tbi-based conditioning (required for all sct) iv. lack of suitable donor v. prior sct vi. 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
boolean
C0023449 (UMLS CUI [1])
C1273390 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1512714 (UMLS CUI [3,1])
C2242529 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4])
C0001779 (UMLS CUI [5])
C0009488 (UMLS CUI [6])
C1301624 (UMLS CUI [7])
C0040288 (UMLS CUI [8,1])
C3900053 (UMLS CUI [8,2])
C0332268 (UMLS CUI [8,3])
C1504389 (UMLS CUI [9,1])
C0205156 (UMLS CUI [9,2])
C1705576 (UMLS CUI [10,1])
C1548437 (UMLS CUI [10,2])
In complete remission | Disease Response Post Therapy | Stable status Post Therapy
Item
. 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.
boolean
C0677874 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0205360 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
Diffuse Large B-Cell Lymphoma | Non-Hodgkin Lymphoma High grade CD19 Positive | Residual disease Post Primary therapy | Ineligibility Transplantation of autologous hematopoietic stem cell | Recurrent disease Post Transplantation of autologous hematopoietic stem cell | Recurrent disease | Persistent Disease | Ineligibility Allogeneic Hematopoietic Stem Cell Transplantation
Item
b. diffuse large cell lymphoma or other high-grade nhl, previously identified as cd19+ i. residual disease after primary therapy and not eligible for autologous sct. ii. relapsed after prior autologous sct. iii. beyond 1st cr with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous sct.
boolean
C0079744 (UMLS CUI [1])
C0024305 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4289895 (UMLS CUI [2,3])
C0543478 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1708063 (UMLS CUI [3,3])
C1512714 (UMLS CUI [4,1])
C1831743 (UMLS CUI [4,2])
C0277556 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C1831743 (UMLS CUI [5,3])
C0277556 (UMLS CUI [6])
C2983415 (UMLS CUI [7])
C1512714 (UMLS CUI [8,1])
C1705576 (UMLS CUI [8,2])
Age
Item
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.
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
3. expected survival > 12 weeks
boolean
C0023671 (UMLS CUI [1])
Creatinine measurement, serum
Item
4. creatinine < 2.5 mg/dl and less than 2.5x normal for age
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
5. alt <= 5x normal
boolean
C0201836 (UMLS CUI [1])
Serum total bilirubin measurement
Item
6. bilirubin <2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Relapse Post Stem cell transplantation
Item
7. any relapse after prior sct will make patient eligible regardless of other prior therapy.
boolean
C0035020 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C1504389 (UMLS CUI [1,3])
Recurrent disease Post Allogeneic Stem Cell Transplantation | Allogeneic Stem Cell Transplantation Myeloablative | Nonmyeloablative allogeneic hematopoietic stem cell transplantation
Item
8. patients with relapsed disease after prior allogeneic sct (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2242529 (UMLS CUI [1,3])
C2242529 (UMLS CUI [2,1])
C4319756 (UMLS CUI [2,2])
C1831742 (UMLS CUI [3])
Graft-vs-Host Disease Absent | Requirement Absent Therapeutic immunosuppression
Item
1. have no active gvhd and require no immunosuppression
boolean
C0018133 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021079 (UMLS CUI [2,3])
Transplantation Previous
Item
2. are more than 4 months from transplant (6 months at infusion)
boolean
C0040732 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Requirement Leukapheresis T cell Collection | Venous access patent Apheresis | Eligibility Catheter placement | Medical contraindication Absent Leukapheresis
Item
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.
boolean
C1514873 (UMLS CUI [1,1])
C0023416 (UMLS CUI [1,2])
C0039194 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,4])
C3164222 (UMLS CUI [2,1])
C0005791 (UMLS CUI [2,2])
C1548635 (UMLS CUI [3,1])
C0883301 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0023416 (UMLS CUI [4,3])
Informed Consent
Item
10. voluntary informed consent is given.
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
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.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
Communicable Disease Uncontrolled
Item
2. uncontrolled active infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Hepatitis B | Hepatitis C
Item
3. active hepatitis b or hepatitis c infection.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Systemic steroids | Condition Requirement Steroid therapy | Inhaled steroids allowed | Hydrocortisone Adrenal gland hypofunction allowed
Item
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.
boolean
C2825233 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0149783 (UMLS CUI [2,3])
C2065041 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0020268 (UMLS CUI [4,1])
C0001623 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Graft-vs-Host Disease CTCAE Grades | Chronic graft-versus-host disease Extensive CTCAE Grades
Item
5. presence of grade 2-4 acute or extensive chronic gvhd.
boolean
C0018133 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0867389 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
Treatment Graft-vs-Host Disease
Item
6. under treatment for gvhd.
boolean
C0087111 (UMLS CUI [1,1])
C0018133 (UMLS CUI [1,2])
Gene Therapy Agent
Item
7. previous treatment with any gene therapy products.
boolean
C1517496 (UMLS CUI [1])
Response Inadequate CD3/CD28 Costimulated Autologous T-Cells
Item
8. feasibility assessment during screening shows insufficient expansion in response to cd3/cd28 costimulation.
boolean
C1704632 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C2347257 (UMLS CUI [1,3])
Disease Uncontrolled | Study Subject Participation Status Excluded
Item
9. any uncontrolled active medical disorder that would preclude participation as outlined.
boolean
C0012634 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
HIV Infection
Item
10. hiv infection.
boolean
C0019693 (UMLS CUI [1])
Central Nervous System Involvement
Item
11. patients with active cns involvement with malignancy (i.e. cns3 for all). patients with prior cns disease that has been effectively treated will be eligible. routine cns prophylaxis for all is permitted.
boolean
C4050309 (UMLS CUI [1])