ID

36592

Description

Phase IIa Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRz and 4-Signaling Domains in Patients With Chemotherapy Relapsed or Refractory CD19+ Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT02030834

Link

https://clinicaltrials.gov/show/NCT02030834

Keywords

Versions (1)
  1. 5/24/19 5/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-Hodgkins Lymphoma (NHL) Patients, With CD19+B Cell Lymphomas With no Available Potentially NCT02030834

English

Eligibility Non-Hodgkins Lymphoma (NHL) Patients, With CD19+B Cell Lymphomas With no Available Potentially NCT02030834

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subjects with cd19+ b cell lymphomas with no available curative treatment options (such as autologous or allogeneic sct) who have a limited prognosis (several months to <2 year survival) with currently available therapies will be enrolled. the study will enroll 30 patients, but will ensure that at least 8 patients each with dlbcl, mcl and fl are included.
Description

B-Cell Lymphoma CD19 Positive | Curative treatment Unavailable | Autologous hematopoietic stem cell transplant Unavailable | Allogeneic hematopoietic stem cell transplant Unavailable | Prognosis Limited | Life Expectancy | Therapeutic procedure Available | Diffuse Large B-Cell Lymphoma | Mantle cell lymphoma | Lymphoma, Follicular

Data type

boolean

Alias
UMLS CUI [1,1]
C0079731
UMLS CUI [1,2]
C4289895
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C0686905
UMLS CUI [3,1]
C2193200
UMLS CUI [3,2]
C0686905
UMLS CUI [4,1]
C4255274
UMLS CUI [4,2]
C0686905
UMLS CUI [5,1]
C0033325
UMLS CUI [5,2]
C0439801
UMLS CUI [6]
C0023671
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0470187
UMLS CUI [8]
C0079744
UMLS CUI [9]
C0334634
UMLS CUI [10]
C0024301
1. cd19+ lymphoma
Description

Lymphoma CD19 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C4289895
a. follicular lymphoma, previously identified as cd19+ i. at least 2 prior chemotherapy or immunochemotherapy regimens (not including single agent monoclonal antibody therapy) ii. patients who progress within 2 years after second or higher line of therapy will be eligible. for instance, patients who have progression of lymphoma < 2 years after second or greater line therapy, but who have responded to their most recent treatment (3rd line or higher) will be eligible. patients may have progression, stable disease or responding disease at the time of enrollment.
Description

Follicular Lymphoma CD19 Positive | Prior Chemotherapy Quantity | Immunochemotherapy Quantity | Monoclonal Antibody Therapy Absent | Disease Progression | Status post Second line treatment | Stable Disease | Disease Response

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C4289895
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C4087148
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0279694
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0242656
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C1710038
UMLS CUI [7]
C0677946
UMLS CUI [8]
C1704632
iii. patients with a history of large cell transformation are eligible. b. mantle cell lymphoma i. beyond 1st cr with relapsed disease, progressive disease during first line rituximab-chemotherapy combination, or persistent disease after first line rituximab-chemotherapy combination and not eligible or appropriate for conventional allogeneic or autologous sct.
Description

Large cell transformation | Mantle cell lymphoma | Recurrent disease | Disease Progression | rituximab | Combination Chemotherapy | Persistent Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1513997
UMLS CUI [1,2]
C0040682
UMLS CUI [2]
C0334634
UMLS CUI [3]
C0277556
UMLS CUI [4]
C0242656
UMLS CUI [5]
C0393022
UMLS CUI [6]
C1521750
UMLS CUI [7]
C2983415
ii. relapsed after prior autologous sct. c. diffuse large b cell lymphoma, previously identified as cd19+ i. residual disease after primary therapy and not eligible for autologous sct ii. relapsed or persistent disease after prior autologous sct iii. beyond 1st cr with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous sct iv. patients with an antecedent history of follicular lymphoma or cll/sll are eligible.
Description

Recurrent disease | Status post Transplantation of autologous hematopoietic stem cell | Diffuse Large B-Cell Lymphoma CD19 Positive | Residual Tumor Post First line treatment | Persistent Disease | Status post Transplantation of autologous hematopoietic stem cell | Lymphoma, Follicular | CLL/SLL

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1831743
UMLS CUI [3,1]
C0079744
UMLS CUI [3,2]
C4289895
UMLS CUI [4,1]
C0543478
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C1708063
UMLS CUI [5]
C2983415
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C1831743
UMLS CUI [7]
C0024301
UMLS CUI [8]
C1302547
2. age ≥18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. expected survival > 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
4. creatinine < 1.6 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
5. alt/ast < 3x upper limit of normal
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
6. bilirubin <2.0 mg/dl, unless subject has gilbert's syndrome (<3.0 mg/dl)
Description

Serum total bilirubin measurement | Exception Gilbert Disease

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0017551
7. any relapse after prior autologous sct will make patient eligible regardless of other prior therapy.
Description

Recurrent disease | Status post Transplantation of autologous hematopoietic stem cell

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1831743
8. patients with relapsed disease after prior allogeneic sct (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and
Description

Recurrent disease | Status post Allogeneic Stem Cell Transplantation | Myeloablation | Myeloablation Absent

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C2242529
UMLS CUI [3]
C4319756
UMLS CUI [4,1]
C4319756
UMLS CUI [4,2]
C0332197
1. have experienced graft rejection (no evidence of donor cells by str analysis on 2 occasions separated by at least 1 month).
Description

Graft Rejection

Data type

boolean

Alias
UMLS CUI [1]
C0018129
2. have no active gvhd and require no immunosuppression
Description

Graft-vs-Host Disease Absent | Therapeutic immunosuppression Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0018133
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0332197
3. are more than 6 months from transplant
Description

Transplantation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C0205156
9. measurable or assessable disease according to the "revised response criteria for malignant lymphoma" (cheson et al., j. clin. onc., 1999)105. patients in complete remission with no evidence of disease are not eligible.
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
10. performance status (ecog) 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
11. written informed consent is given.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
12. successful t cell test expansion (first 10 subjects
Description

T-Lymphocyte expansion

Data type

boolean

Alias
UMLS CUI [1,1]
C0039194
UMLS CUI [1,2]
C0007595
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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 pregnancy test at enrollment. a urine pregnancy test will be performed within 48 hours before infusion.
Description

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test requested

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0420639
2. uncontrolled active infection. 3. active hepatitis b or hepatitis c infection. 4. concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary.
Description

Communicable Disease Uncontrolled | Hepatitis B | Hepatitis C | Systemic steroids | Inhaled steroids allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C2825233
UMLS CUI [5,1]
C2065041
UMLS CUI [5,2]
C0683607
5. any uncontrolled active medical disorder that would preclude participation as outlined.
Description

Disease Uncontrolled | Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332196
6. hiv infection. 7. patients with active cns involvement by malignancy. patients with prior cns disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment 8. patients in complete remission with no assessable disease.
Description

HIV Infection | Central Nervous System Involvement | Complete remission

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C4050309
UMLS CUI [3]
C0677874
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Similar models

Eligibility Non-Hodgkins Lymphoma (NHL) Patients, With CD19+B Cell Lymphomas With no Available Potentially NCT02030834

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
B-Cell Lymphoma CD19 Positive | Curative treatment Unavailable | Autologous hematopoietic stem cell transplant Unavailable | Allogeneic hematopoietic stem cell transplant Unavailable | Prognosis Limited | Life Expectancy | Therapeutic procedure Available | Diffuse Large B-Cell Lymphoma | Mantle cell lymphoma | Lymphoma, Follicular
Item
male or female subjects with cd19+ b cell lymphomas with no available curative treatment options (such as autologous or allogeneic sct) who have a limited prognosis (several months to <2 year survival) with currently available therapies will be enrolled. the study will enroll 30 patients, but will ensure that at least 8 patients each with dlbcl, mcl and fl are included.
boolean
C0079731 (UMLS CUI [1,1])
C4289895 (UMLS CUI [1,2])
C1273390 (UMLS CUI [2,1])
C0686905 (UMLS CUI [2,2])
C2193200 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C4255274 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
C0033325 (UMLS CUI [5,1])
C0439801 (UMLS CUI [5,2])
C0023671 (UMLS CUI [6])
C0087111 (UMLS CUI [7,1])
C0470187 (UMLS CUI [7,2])
C0079744 (UMLS CUI [8])
C0334634 (UMLS CUI [9])
C0024301 (UMLS CUI [10])
Lymphoma CD19 Positive
Item
1. cd19+ lymphoma
boolean
C0024299 (UMLS CUI [1,1])
C4289895 (UMLS CUI [1,2])
Follicular Lymphoma CD19 Positive | Prior Chemotherapy Quantity | Immunochemotherapy Quantity | Monoclonal Antibody Therapy Absent | Disease Progression | Status post Second line treatment | Stable Disease | Disease Response
Item
a. follicular lymphoma, previously identified as cd19+ i. at least 2 prior chemotherapy or immunochemotherapy regimens (not including single agent monoclonal antibody therapy) ii. patients who progress within 2 years after second or higher line of therapy will be eligible. for instance, patients who have progression of lymphoma < 2 years after second or greater line therapy, but who have responded to their most recent treatment (3rd line or higher) will be eligible. patients may have progression, stable disease or responding disease at the time of enrollment.
boolean
C0024301 (UMLS CUI [1,1])
C4289895 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C4087148 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0279694 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0242656 (UMLS CUI [5])
C0231290 (UMLS CUI [6,1])
C1710038 (UMLS CUI [6,2])
C0677946 (UMLS CUI [7])
C1704632 (UMLS CUI [8])
Large cell transformation | Mantle cell lymphoma | Recurrent disease | Disease Progression | rituximab | Combination Chemotherapy | Persistent Disease
Item
iii. patients with a history of large cell transformation are eligible. b. mantle cell lymphoma i. beyond 1st cr with relapsed disease, progressive disease during first line rituximab-chemotherapy combination, or persistent disease after first line rituximab-chemotherapy combination and not eligible or appropriate for conventional allogeneic or autologous sct.
boolean
C1513997 (UMLS CUI [1,1])
C0040682 (UMLS CUI [1,2])
C0334634 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
C0393022 (UMLS CUI [5])
C1521750 (UMLS CUI [6])
C2983415 (UMLS CUI [7])
Recurrent disease | Status post Transplantation of autologous hematopoietic stem cell | Diffuse Large B-Cell Lymphoma CD19 Positive | Residual Tumor Post First line treatment | Persistent Disease | Status post Transplantation of autologous hematopoietic stem cell | Lymphoma, Follicular | CLL/SLL
Item
ii. relapsed after prior autologous sct. c. diffuse large b cell lymphoma, previously identified as cd19+ i. residual disease after primary therapy and not eligible for autologous sct ii. relapsed or persistent disease after prior autologous sct iii. beyond 1st cr with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous sct iv. patients with an antecedent history of follicular lymphoma or cll/sll are eligible.
boolean
C0277556 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1831743 (UMLS CUI [2,2])
C0079744 (UMLS CUI [3,1])
C4289895 (UMLS CUI [3,2])
C0543478 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C1708063 (UMLS CUI [4,3])
C2983415 (UMLS CUI [5])
C0231290 (UMLS CUI [6,1])
C1831743 (UMLS CUI [6,2])
C0024301 (UMLS CUI [7])
C1302547 (UMLS CUI [8])
Age
Item
2. age ≥18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
3. expected survival > 12 weeks
boolean
C0023671 (UMLS CUI [1])
Creatinine measurement, serum
Item
4. creatinine < 1.6 mg/dl
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
5. alt/ast < 3x upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Serum total bilirubin measurement | Exception Gilbert Disease
Item
6. bilirubin <2.0 mg/dl, unless subject has gilbert's syndrome (<3.0 mg/dl)
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0017551 (UMLS CUI [2,2])
Recurrent disease | Status post Transplantation of autologous hematopoietic stem cell
Item
7. any relapse after prior autologous sct will make patient eligible regardless of other prior therapy.
boolean
C0277556 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1831743 (UMLS CUI [2,2])
Recurrent disease | Status post Allogeneic Stem Cell Transplantation | Myeloablation | Myeloablation Absent
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])
C0231290 (UMLS CUI [2,1])
C2242529 (UMLS CUI [2,2])
C4319756 (UMLS CUI [3])
C4319756 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Graft Rejection
Item
1. have experienced graft rejection (no evidence of donor cells by str analysis on 2 occasions separated by at least 1 month).
boolean
C0018129 (UMLS CUI [1])
Graft-vs-Host Disease Absent | Therapeutic immunosuppression Absent
Item
2. have no active gvhd and require no immunosuppression
boolean
C0018133 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Transplantation Previous
Item
3. are more than 6 months from transplant
boolean
C0040732 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Measurable Disease | Evaluable Disease
Item
9. measurable or assessable disease according to the "revised response criteria for malignant lymphoma" (cheson et al., j. clin. onc., 1999)105. patients in complete remission with no evidence of disease are not eligible.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
ECOG performance status
Item
10. performance status (ecog) 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
11. written informed consent is given.
boolean
C0021430 (UMLS CUI [1])
T-Lymphocyte expansion
Item
12. successful t cell test expansion (first 10 subjects
boolean
C0039194 (UMLS CUI [1,1])
C0007595 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test requested
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 pregnancy test at enrollment. a urine pregnancy test will be 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])
C0420639 (UMLS CUI [4,2])
Communicable Disease Uncontrolled | Hepatitis B | Hepatitis C | Systemic steroids | Inhaled steroids allowed
Item
2. uncontrolled active infection. 3. active hepatitis b or hepatitis c infection. 4. concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C2825233 (UMLS CUI [4])
C2065041 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
Disease Uncontrolled | Study Subject Participation Status Excluded
Item
5. 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 | Central Nervous System Involvement | Complete remission
Item
6. hiv infection. 7. patients with active cns involvement by malignancy. patients with prior cns disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment 8. patients in complete remission with no assessable disease.
boolean
C0019693 (UMLS CUI [1])
C4050309 (UMLS CUI [2])
C0677874 (UMLS CUI [3])
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