ID

39083

Description

Feasibility Study Of Adding Bortezomib to R-ICE Chemotherapy To Treat Relapsed/ Refractory Diffuse Large B-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01226849

Link

https://clinicaltrials.gov/show/NCT01226849

Keywords

Versions (1)
  1. 11/29/19 11/29/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 29, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diffuse Large B-Cell Lymphoma NCT01226849

English

Eligibility Diffuse Large B-Cell Lymphoma NCT01226849

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically proven diffuse large b-cell lymphoma in first relapse after cr, less than pr or pr to first line treatment de novo dlbcl, dlbcl arising from transformed follicular lymphoma or chronic lymphocytic leukaemia are allowed.
Description

Diffuse Large B-Cell Lymphoma First Relapse | Status post Complete remission | Less Than Partial response | Partial response First line treatment Diffuse Large B-Cell Lymphoma de novo | Diffuse Large B-Cell Lymphoma Due to Follicular Lymphoma Transformed | Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C4054953
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0677874
UMLS CUI [3,1]
C0439092
UMLS CUI [3,2]
C1521726
UMLS CUI [4,1]
C1521726
UMLS CUI [4,2]
C1708063
UMLS CUI [4,3]
C0079744
UMLS CUI [4,4]
C1515568
UMLS CUI [5,1]
C0079744
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0024301
UMLS CUI [5,4]
C0457344
UMLS CUI [6]
C0023434
prior rituximab is allowed prior radiation is allowed prior autologous stem cell transplant is allowed cd20 negative relapses are allowed
Description

rituximab | Prior radiation therapy | Autologous hematopoietic stem cell transplant | Relapse CD20 Negative

Data type

boolean

Alias
UMLS CUI [1]
C0393022
UMLS CUI [2]
C0279134
UMLS CUI [3]
C2193200
UMLS CUI [4,1]
C0035020
UMLS CUI [4,2]
C4527200
2. age between 21-70
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
4. eastern cooperative oncology group (ecog) performance status of 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. minimum life expectancy of 3 months
Description

Life Expectancy Minimum

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C1524031
6. previously treated with chemotherapy containing anthracyclines and rituximab
Description

Prior Chemotherapy | Anthracyclines | rituximab

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0282564
UMLS CUI [3]
C0393022
7. negative urine or serum pregnancy test on females of childbearing potential
Description

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430061
8. female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
Description

Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Contraceptives, Oral, Hormonal | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0009907
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0042241
UMLS CUI [7]
C0087145
UMLS CUI [8]
C0221829
UMLS CUI [9]
C0036899
9. male subject agrees to use an acceptable method for contraception for the duration of the study.
Description

Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
10. no cns involvement
Description

Central Nervous System Involvement Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0332197
11. measurable disease on ct scan by international working group response criteria
Description

Measurable Disease CT scan

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior allogeneic transplantation
Description

Transplantation, Homologous

Data type

boolean

Alias
UMLS CUI [1]
C0040739
2. prior treatment with bortezomib
Description

bortezomib

Data type

boolean

Alias
UMLS CUI [1]
C1176309
3. concomitant use of any other anti-cancer therapy
Description

Cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
4. concomitant use of any other investigational agent
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
5. known infection with human immunodeficiency virus (hiv)
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
6. patient has known clinically active hepatitis b (carriers of hepatitis b are permitted to enter the study)
Description

Hepatitis B | Hepatitis B carrier allowed

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2,1]
C0262505
UMLS CUI [2,2]
C0683607
7. contraindication to any drug contained in chemotherapy regimens
Description

Medical contraindication Chemotherapeutic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003392
8. not previously treated with anthracycline-containing regimens
Description

Absence Regimen Containing Anthracyclines

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0040808
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0282564
9. impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule
Description

Liver Dysfunction | Renal Insufficiency | Organ dysfunction Interferes with Treatment Protocol | Exception Organ dysfunction caused by Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
UMLS CUI [3,1]
C0349410
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0040808
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0349410
UMLS CUI [4,3]
C0015127
UMLS CUI [4,4]
C0024299
10. poor bone marrow reserve (neutrophils <1.0 x 109/l or platelets <75 x 10(9)/l unless related to bone marrow infiltration
Description

Few mature neutrophils in the bone marrow | Neutrophil count | Platelet Count measurement | Exception Relationship Bone marrow infiltration

Data type

boolean

Alias
UMLS CUI [1]
C2748959
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0439849
UMLS CUI [4,3]
C3854434
11. subject has a calculated or measured creatinine clearance of <20 ml/minute within 14 days before enrollment.
Description

Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0373595
12. myocardial infarction within 6 months prior to enrollment or has new york hospital association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. prior to study entry, any ecg abnormality at screening has to be documented by the investigator as not medically relevant.
Description

Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia ECG | Conduction system abnormalities | ECG abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0205318
UMLS CUI [5,1]
C0022116
UMLS CUI [5,2]
C1623258
UMLS CUI [6]
C0151236
UMLS CUI [7]
C0522055
13. clinically significant active infection
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
14. subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
Description

Peripheral Neuropathy CTCAE Grades | Peripheral Neuropathy with Pain CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0031117
UMLS CUI [2,2]
C0332287
UMLS CUI [2,3]
C0030193
UMLS CUI [2,4]
C1516728
15. patients who are pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
16. coexistent second malignancy or history of prior malignancy within previous 3 years (excluding non-melanoma skin tumors or in situ carcinoma of the cervix)
Description

Second Cancer | Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
17. any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
Description

Medical condition Preventing Protocol Compliance | Mental condition Preventing Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3840291
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0525058
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Similar models

Eligibility Diffuse Large B-Cell Lymphoma NCT01226849

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma First Relapse | Status post Complete remission | Less Than Partial response | Partial response First line treatment Diffuse Large B-Cell Lymphoma de novo | Diffuse Large B-Cell Lymphoma Due to Follicular Lymphoma Transformed | Chronic Lymphocytic Leukemia
Item
1. histologically proven diffuse large b-cell lymphoma in first relapse after cr, less than pr or pr to first line treatment de novo dlbcl, dlbcl arising from transformed follicular lymphoma or chronic lymphocytic leukaemia are allowed.
boolean
C0079744 (UMLS CUI [1,1])
C4054953 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
C0439092 (UMLS CUI [3,1])
C1521726 (UMLS CUI [3,2])
C1521726 (UMLS CUI [4,1])
C1708063 (UMLS CUI [4,2])
C0079744 (UMLS CUI [4,3])
C1515568 (UMLS CUI [4,4])
C0079744 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0024301 (UMLS CUI [5,3])
C0457344 (UMLS CUI [5,4])
C0023434 (UMLS CUI [6])
rituximab | Prior radiation therapy | Autologous hematopoietic stem cell transplant | Relapse CD20 Negative
Item
prior rituximab is allowed prior radiation is allowed prior autologous stem cell transplant is allowed cd20 negative relapses are allowed
boolean
C0393022 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
C2193200 (UMLS CUI [3])
C0035020 (UMLS CUI [4,1])
C4527200 (UMLS CUI [4,2])
Age
Item
2. age between 21-70
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
3. written informed consent
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy Minimum
Item
5. minimum life expectancy of 3 months
boolean
C0023671 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
Prior Chemotherapy | Anthracyclines | rituximab
Item
6. previously treated with chemotherapy containing anthracyclines and rituximab
boolean
C1514457 (UMLS CUI [1])
C0282564 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
7. negative urine or serum pregnancy test on females of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Contraceptives, Oral, Hormonal | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Sexual Abstinence
Item
8. female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0009907 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0221829 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
Gender Contraceptive methods
Item
9. male subject agrees to use an acceptable method for contraception for the duration of the study.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Central Nervous System Involvement Absent
Item
10. no cns involvement
boolean
C4050309 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Measurable Disease CT scan
Item
11. measurable disease on ct scan by international working group response criteria
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Transplantation, Homologous
Item
1. prior allogeneic transplantation
boolean
C0040739 (UMLS CUI [1])
bortezomib
Item
2. prior treatment with bortezomib
boolean
C1176309 (UMLS CUI [1])
Cancer treatment
Item
3. concomitant use of any other anti-cancer therapy
boolean
C0920425 (UMLS CUI [1])
Investigational New Drugs
Item
4. concomitant use of any other investigational agent
boolean
C0013230 (UMLS CUI [1])
HIV Infection
Item
5. known infection with human immunodeficiency virus (hiv)
boolean
C0019693 (UMLS CUI [1])
Hepatitis B | Hepatitis B carrier allowed
Item
6. patient has known clinically active hepatitis b (carriers of hepatitis b are permitted to enter the study)
boolean
C0019163 (UMLS CUI [1])
C0262505 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Medical contraindication Chemotherapeutic Agents
Item
7. contraindication to any drug contained in chemotherapy regimens
boolean
C1301624 (UMLS CUI [1,1])
C0003392 (UMLS CUI [1,2])
Absence Regimen Containing Anthracyclines
Item
8. not previously treated with anthracycline-containing regimens
boolean
C0332197 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0282564 (UMLS CUI [1,4])
Liver Dysfunction | Renal Insufficiency | Organ dysfunction Interferes with Treatment Protocol | Exception Organ dysfunction caused by Lymphoma
Item
9. impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0349410 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0040808 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0349410 (UMLS CUI [4,2])
C0015127 (UMLS CUI [4,3])
C0024299 (UMLS CUI [4,4])
Few mature neutrophils in the bone marrow | Neutrophil count | Platelet Count measurement | Exception Relationship Bone marrow infiltration
Item
10. poor bone marrow reserve (neutrophils <1.0 x 109/l or platelets <75 x 10(9)/l unless related to bone marrow infiltration
boolean
C2748959 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0439849 (UMLS CUI [4,2])
C3854434 (UMLS CUI [4,3])
Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
Item
11. subject has a calculated or measured creatinine clearance of <20 ml/minute within 14 days before enrollment.
boolean
C2711451 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Ventricular arrhythmia Severe Uncontrolled | Ischemia ECG | Conduction system abnormalities | ECG abnormal
Item
12. myocardial infarction within 6 months prior to enrollment or has new york hospital association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. prior to study entry, any ecg abnormality at screening has to be documented by the investigator as not medically relevant.
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0022116 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C0151236 (UMLS CUI [6])
C0522055 (UMLS CUI [7])
Communicable Disease
Item
13. clinically significant active infection
boolean
C0009450 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades | Peripheral Neuropathy with Pain CTCAE Grades
Item
14. subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0031117 (UMLS CUI [2,1])
C0332287 (UMLS CUI [2,2])
C0030193 (UMLS CUI [2,3])
C1516728 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
15. patients who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Second Cancer | Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
16. coexistent second malignancy or history of prior malignancy within previous 3 years (excluding non-melanoma skin tumors or in situ carcinoma of the cervix)
boolean
C0751623 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Medical condition Preventing Protocol Compliance | Mental condition Preventing Protocol Compliance
Item
17. any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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