ID

37694

Description

Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01626495

Link

https://clinicaltrials.gov/show/NCT01626495

Keywords

Versions (1)
  1. 8/18/19 8/18/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 18, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility B Cell Leukemia NCT01626495

English

Eligibility B Cell Leukemia NCT01626495

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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:
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C2004493
UMLS CUI [2,2]
C4289895
UMLS CUI [3,1]
C1273390
UMLS CUI [3,2]
C0686905
UMLS CUI [4,1]
C1831743
UMLS CUI [4,2]
C0686905
UMLS CUI [5,1]
C2242529
UMLS CUI [5,2]
C0686905
UMLS CUI [6,1]
C0033325
UMLS CUI [6,2]
C0439801
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0470187
UMLS CUI [8]
C0023671
1. eligible diseases: cd19+ leukemia or lymphoma
Description

Leukemia CD19 Positive | Lymphoma CD19 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0023418
UMLS CUI [1,2]
C4289895
UMLS CUI [2,1]
C0024299
UMLS CUI [2,2]
C4289895
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1512714
UMLS CUI [3,2]
C2242529
UMLS CUI [4]
C0015127
UMLS CUI [5]
C0001779
UMLS CUI [6]
C0009488
UMLS CUI [7]
C1301624
UMLS CUI [8,1]
C0040288
UMLS CUI [8,2]
C3900053
UMLS CUI [8,3]
C0332268
UMLS CUI [9,1]
C1504389
UMLS CUI [9,2]
C0205156
UMLS CUI [10,1]
C1705576
UMLS CUI [10,2]
C1548437
. 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.
Description

In complete remission | Disease Response Post Therapy | Stable status Post Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C0205360
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0087111
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0079744
UMLS CUI [2,1]
C0024305
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C4289895
UMLS CUI [3,1]
C0543478
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C1708063
UMLS CUI [4,1]
C1512714
UMLS CUI [4,2]
C1831743
UMLS CUI [5,1]
C0277556
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C1831743
UMLS CUI [6]
C0277556
UMLS CUI [7]
C2983415
UMLS CUI [8,1]
C1512714
UMLS CUI [8,2]
C1705576
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.
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 < 2.5 mg/dl and less than 2.5x normal for age
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
5. alt <= 5x normal
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
6. bilirubin <2.0 mg/dl
Description

Serum total bilirubin measurement

Data type

boolean

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

Relapse Post Stem cell transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C1504389
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 Post Allogeneic Stem Cell Transplantation | Allogeneic Stem Cell Transplantation Myeloablative | Nonmyeloablative allogeneic hematopoietic stem cell transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C2242529
UMLS CUI [2,1]
C2242529
UMLS CUI [2,2]
C4319756
UMLS CUI [3]
C1831742
1. have no active gvhd and require no immunosuppression
Description

Graft-vs-Host Disease Absent | Requirement Absent Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1,1]
C0018133
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0021079
2. are more than 4 months from transplant (6 months at infusion)
Description

Transplantation Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0040732
UMLS CUI [1,2]
C0205156
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.
Description

Requirement Leukapheresis T cell Collection | Venous access patent Apheresis | Eligibility Catheter placement | Medical contraindication Absent Leukapheresis

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0023416
UMLS CUI [1,3]
C0039194
UMLS CUI [1,4]
C0200345
UMLS CUI [2,1]
C3164222
UMLS CUI [2,2]
C0005791
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0883301
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0023416
10. voluntary informed consent is given.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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 or urine pregnancy test performed within 48 hours before infusion.
Description

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

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]
C0430057
2. uncontrolled active infection.
Description

Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
3. active hepatitis b or hepatitis c infection.
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
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.
Description

Systemic steroids | Condition Requirement Steroid therapy | Inhaled steroids allowed | Hydrocortisone Adrenal gland hypofunction allowed

Data type

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0149783
UMLS CUI [3,1]
C2065041
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0020268
UMLS CUI [4,2]
C0001623
UMLS CUI [4,3]
C0683607
5. presence of grade 2-4 acute or extensive chronic gvhd.
Description

Graft-vs-Host Disease CTCAE Grades | Chronic graft-versus-host disease Extensive CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0018133
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0867389
UMLS CUI [2,2]
C0205231
UMLS CUI [2,3]
C1516728
6. under treatment for gvhd.
Description

Treatment Graft-vs-Host Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0018133
7. previous treatment with any gene therapy products.
Description

Gene Therapy Agent

Data type

boolean

Alias
UMLS CUI [1]
C1517496
8. feasibility assessment during screening shows insufficient expansion in response to cd3/cd28 costimulation.
Description

Response Inadequate CD3/CD28 Costimulated Autologous T-Cells

Data type

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C2347257
9. 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
10. hiv infection.
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
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.
Description

Central Nervous System Involvement

Data type

boolean

Alias
UMLS CUI [1]
C4050309
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Similar models

Eligibility B Cell Leukemia NCT01626495

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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