ID

44206

Description

Phase 3 Multi-center Randomized Study to Compare Efficacy and Safety of Romidepsin CHOP (Ro-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01796002

Link

https://clinicaltrials.gov/show/NCT01796002

Keywords

Versions (3)
  1. 6/6/18 6/6/18 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  3. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Peripheral T-cell Lymphoma NCT01796002

English

Eligibility Peripheral T-cell Lymphoma NCT01796002

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males and females of 18 years of age to 80 years of age.
Description

patient gender and age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
3. able to adhere to the study visit schedule and other protocol requirements.
Description

protocol compliance, compliance behaviour

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C1321605
4. patients with histologically proven peripheral t-cell lymphoma (ptcl), not previously treated; the following subtypes as defined by the who classification (2008;2011) may be included, whatever the ann arbor stage (i - iv):
Description

untreated t-cell lymphoma, histologically proven | ann arbor stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0079772
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0432516
a. nodal types: i. ptcl, not otherwise specified ii. angioimmunoblastic t-cell lymphoma iii. anaplastic large cell lymphoma, alk-negative type
Description

Peripheral T-Cell Lymphoma | Angioimmunoblastic Lymphadenopathy | Anaplastic Large Cell Lymphoma, ALK-Negative

Data type

boolean

Alias
UMLS CUI [1]
C0079774
UMLS CUI [2]
C0020981
UMLS CUI [3]
C1332078
b. extra-nodal types: i. enteropathy-associated t-cell lymphoma ii. hepato-splenic t-cell lymphoma iii. subcutaneous panniculitis-like t-cell lymphoma iv. primary cutaneous gamma-delta t-cell lymphoma v. primary cutaneous cd8+ aggressive epidermotropic lymphoma vi. primary cutaneous cd4+ small/medium t-cell lymphoma
Description

Enteropathy-Associated T-Cell Lymphoma | Hepatosplenic T-Cell Lymphoma | Subcutaneous panniculitis-like T-cell lymphoma | Primary Cutaneous Gamma-Delta T-Cell Lymphoma | Primary Cutaneous CD8-Positive Aggressive Epidermotropic T-Cell Lymphoma | Primary Cutaneous CD4-Positive Small/Medium-Sized T-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0456889
UMLS CUI [2]
C0522627
UMLS CUI [3]
C0522624
UMLS CUI [4]
C1707547
UMLS CUI [5]
C4518232
UMLS CUI [6]
C1709654
c. other non classifiable peripheral t-cell lymphoma
Description

T-Cell lymphoma, not classified

Data type

boolean

Alias
UMLS CUI [1,1]
C0079772
UMLS CUI [1,2]
C0205426
5. ecog performance status 0, 1 or 2
Description

ECOG Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. negative pregnancy test for females of childbearing potential (fcbp)
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
7. female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; males must use an effective method of birth control during treatment period and 3 months thereafter.
Description

birth control

Data type

boolean

Alias
UMLS CUI [1]
C0700589
8. life expectancy of ≥ 90 days (3 months).
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
2. any condition that confounds the ability to interpret data from the study.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
3. other types of lymphomas, e.g. b-cell lymphoma
Description

other lymphomas | b-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0079731
4. the following types of t cell lymphomas:
Description

t-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0079772
1. adult t-cell lymphoma/leukemia (htlv-1 related t-cell lymphoma)
Description

Adult T-Cell Lymphoma/Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023493
2. extranodal t-cell/nk-cell lymphoma, nasal type
Description

Nasal Type Extranodal NK/T-Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0392788
3. anaplastic large cell lymphoma, alk-positive type
Description

Anaplastic Large Cell Lymphoma, ALK-Positive

Data type

boolean

Alias
UMLS CUI [1]
C1332079
4. cutaneous t cell lymphoma (mycosis fungoid, sézary syndrome)
Description

Lymphoma, T-Cell, Cutaneous | mycosis fungoid | Sezary Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0079773
UMLS CUI [2]
C0036920
5. primary cutaneous cd30+ t-cell lymphoproliferative disorder
Description

Primary Cutaneous CD30-Positive T-Cell Lymphoproliferative Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1371159
6. primary cutaneous anaplastic t-cell lymphoma
Description

Primary Cutaneous Anaplastic Large Cell Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1301362
5. previous treatment for ptcl with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before randomization
Description

previous Peripheral T-Cell Lymphoma treatment - immunotherapy or chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0079774
UMLS CUI [1,2]
C0021083
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C0079774
UMLS CUI [2,2]
C3665472
UMLS CUI [2,3]
C0205156
6. previous radiotherapy for ptcl except if localized to one lymph node area
Description

previous radiotherapy for primary t cell lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0079774
UMLS CUI [1,2]
C1522449C0205156
7. patients planned for autologous or allogeneic transplant as consolidation in first line
Description

planned autologous or allogeneic transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0194037
UMLS CUI [1,2]
C0149615
UMLS CUI [1,3]
C1301732
8. central nervous system -meningeal involvement
Description

CNS involvment

Data type

boolean

Alias
UMLS CUI [1]
C4050309
9. contraindication to any drug contained in the chemotherapy regimen,
Description

experimental drug contraindication

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
10. subjects with hiv positivity
Description

hiv positiv

Data type

boolean

Alias
UMLS CUI [1]
C0019699
11. subjects with active hepatitis b or c. chronic carriers of hepatitis b without hbv dna positive blood are eligible. subjects with non-active hepatitis c (with normal transaminases) are eligible.
Description

active hepatitis b | active hepatitis c

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
12. any of the following laboratory abnormalities, except if secondary to the lymphoma:
Description

laboratory abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C1853129
1. absolute neutrophil count (anc) < 1,500 cells/mm3 (1.5 x 109/l),
Description

ANC

Data type

boolean

Alias
UMLS CUI [1]
C0948762
2. platelet count < 100,000/mm3 (100 x 109/l), or < 75,000/mm3 if bone marrow is involved,
Description

platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
3. serum sgot/ast or sgpt/alt ≥ 3.0 x upper limit of normal (uln),
Description

ast | alt

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
4. serum total bilirubin > 2 x uln, except in case of hemolytic anemia,
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
5. k+ and mg2+ levels < lln, except if corrected per protocol guidance before beginning the romidepsin infusion
Description

serum potassium | serum magnesium

Data type

boolean

Alias
UMLS CUI [1]
C0202194
UMLS CUI [2]
C0373675
13. serum creatinine > 2.0 x uln
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
14. prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
Description

medical history malignant neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
15. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
Description

informed consent unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
16. any known cardiac abnormalities such as:
Description

cardiac abnormalities

Data type

boolean

Alias
UMLS CUI [1]
C0018799
1. patients with congenital long qt syndrome
Description

congenital long qt syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1141890
2. corrected qt interval > 480 msec (using the fridericia formula)
Description

corrrected qt interval

Data type

boolean

Alias
UMLS CUI [1]
C0577807
3. myocardial infarction within 6 months of cycle 1 day 1
Description

history ofmyocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C1275835
4. history of or concomitant significant cardiovascular disease
Description

medical history concomitant cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0007222
5. ejection fraction <45% by muga scan or by echocardiogram;
Description

cardiac ejection fraction | muga scan | echocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C0521317
UMLS CUI [3]
C0013516
17. concomitant use of drugs that may cause a significant prolongation of the qtc
Description

concomitant drugs prolonging qtc

Data type

boolean

Alias
UMLS CUI [1,1]
C1560305
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C2347852
18. patients who have received more than 200 mg/m2 doxorubicin
Description

Doxorubicin

Data type

boolean

Alias
UMLS CUI [1]
C0013089
19. concomitant use of strong cyp3a4 inhibitors
Description

cyp3a4 inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3830624
20. concomitant use of therapeutic warfarin due to a potential drug interaction. use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted.
Description

warfarin

Data type

boolean

Alias
UMLS CUI [1]
C0043031
21. clinically significant active infection
Description

clinically significant active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
22. use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (day 1) of study drug
Description

standart anti-cancer drug | experimental anti-cancer drug

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0304229
23. pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study.
Description

pregnancy | lactation | contraceptive use

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C1999124
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Similar models

Eligibility Peripheral T-cell Lymphoma NCT01796002

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
patient gender and age
Item
1. males and females of 18 years of age to 80 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
informed consent
Item
2. understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
boolean
C0021430 (UMLS CUI [1])
protocol compliance, compliance behaviour
Item
3. able to adhere to the study visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
untreated t-cell lymphoma, histologically proven | ann arbor stage
Item
4. patients with histologically proven peripheral t-cell lymphoma (ptcl), not previously treated; the following subtypes as defined by the who classification (2008;2011) may be included, whatever the ann arbor stage (i - iv):
boolean
C0079772 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0432516 (UMLS CUI [2])
Peripheral T-Cell Lymphoma | Angioimmunoblastic Lymphadenopathy | Anaplastic Large Cell Lymphoma, ALK-Negative
Item
a. nodal types: i. ptcl, not otherwise specified ii. angioimmunoblastic t-cell lymphoma iii. anaplastic large cell lymphoma, alk-negative type
boolean
C0079774 (UMLS CUI [1])
C0020981 (UMLS CUI [2])
C1332078 (UMLS CUI [3])
Enteropathy-Associated T-Cell Lymphoma | Hepatosplenic T-Cell Lymphoma | Subcutaneous panniculitis-like T-cell lymphoma | Primary Cutaneous Gamma-Delta T-Cell Lymphoma | Primary Cutaneous CD8-Positive Aggressive Epidermotropic T-Cell Lymphoma | Primary Cutaneous CD4-Positive Small/Medium-Sized T-Cell Lymphoma
Item
b. extra-nodal types: i. enteropathy-associated t-cell lymphoma ii. hepato-splenic t-cell lymphoma iii. subcutaneous panniculitis-like t-cell lymphoma iv. primary cutaneous gamma-delta t-cell lymphoma v. primary cutaneous cd8+ aggressive epidermotropic lymphoma vi. primary cutaneous cd4+ small/medium t-cell lymphoma
boolean
C0456889 (UMLS CUI [1])
C0522627 (UMLS CUI [2])
C0522624 (UMLS CUI [3])
C1707547 (UMLS CUI [4])
C4518232 (UMLS CUI [5])
C1709654 (UMLS CUI [6])
T-Cell lymphoma, not classified
Item
c. other non classifiable peripheral t-cell lymphoma
boolean
C0079772 (UMLS CUI [1,1])
C0205426 (UMLS CUI [1,2])
ECOG Performance Status
Item
5. ecog performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
pregnancy
Item
6. negative pregnancy test for females of childbearing potential (fcbp)
boolean
C0032961 (UMLS CUI [1])
birth control
Item
7. female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; males must use an effective method of birth control during treatment period and 3 months thereafter.
boolean
C0700589 (UMLS CUI [1])
life expectancy
Item
8. life expectancy of ≥ 90 days (3 months).
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
1. any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
boolean
C0009488 (UMLS CUI [1])
comorbidity
Item
2. any condition that confounds the ability to interpret data from the study.
boolean
C0009488 (UMLS CUI [1])
other lymphomas | b-cell lymphoma
Item
3. other types of lymphomas, e.g. b-cell lymphoma
boolean
C0024299 (UMLS CUI [1,1])
C0079731 (UMLS CUI [1,2])
t-cell lymphoma
Item
4. the following types of t cell lymphomas:
boolean
C0079772 (UMLS CUI [1])
Adult T-Cell Lymphoma/Leukemia
Item
1. adult t-cell lymphoma/leukemia (htlv-1 related t-cell lymphoma)
boolean
C0023493 (UMLS CUI [1])
Nasal Type Extranodal NK/T-Cell Lymphoma
Item
2. extranodal t-cell/nk-cell lymphoma, nasal type
boolean
C0392788 (UMLS CUI [1])
Anaplastic Large Cell Lymphoma, ALK-Positive
Item
3. anaplastic large cell lymphoma, alk-positive type
boolean
C1332079 (UMLS CUI [1])
Lymphoma, T-Cell, Cutaneous | mycosis fungoid | Sezary Syndrome
Item
4. cutaneous t cell lymphoma (mycosis fungoid, sézary syndrome)
boolean
C0079773 (UMLS CUI [1])
C0036920 (UMLS CUI [2])
Primary Cutaneous CD30-Positive T-Cell Lymphoproliferative Disorder
Item
5. primary cutaneous cd30+ t-cell lymphoproliferative disorder
boolean
C1371159 (UMLS CUI [1])
Primary Cutaneous Anaplastic Large Cell Lymphoma
Item
6. primary cutaneous anaplastic t-cell lymphoma
boolean
C1301362 (UMLS CUI [1])
previous Peripheral T-Cell Lymphoma treatment - immunotherapy or chemotherapy
Item
5. previous treatment for ptcl with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before randomization
boolean
C0079774 (UMLS CUI [1,1])
C0021083 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0079774 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
previous radiotherapy for primary t cell lymphoma
Item
6. previous radiotherapy for ptcl except if localized to one lymph node area
boolean
C0079774 (UMLS CUI [1,1])
C1522449C0205156 (UMLS CUI [1,2])
planned autologous or allogeneic transplant
Item
7. patients planned for autologous or allogeneic transplant as consolidation in first line
boolean
C0194037 (UMLS CUI [1,1])
C0149615 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CNS involvment
Item
8. central nervous system -meningeal involvement
boolean
C4050309 (UMLS CUI [1])
experimental drug contraindication
Item
9. contraindication to any drug contained in the chemotherapy regimen,
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
hiv positiv
Item
10. subjects with hiv positivity
boolean
C0019699 (UMLS CUI [1])
active hepatitis b | active hepatitis c
Item
11. subjects with active hepatitis b or c. chronic carriers of hepatitis b without hbv dna positive blood are eligible. subjects with non-active hepatitis c (with normal transaminases) are eligible.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
laboratory abnormalities
Item
12. any of the following laboratory abnormalities, except if secondary to the lymphoma:
boolean
C1853129 (UMLS CUI [1])
ANC
Item
1. absolute neutrophil count (anc) < 1,500 cells/mm3 (1.5 x 109/l),
boolean
C0948762 (UMLS CUI [1])
platelet count
Item
2. platelet count < 100,000/mm3 (100 x 109/l), or < 75,000/mm3 if bone marrow is involved,
boolean
C0032181 (UMLS CUI [1])
ast | alt
Item
3. serum sgot/ast or sgpt/alt ≥ 3.0 x upper limit of normal (uln),
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
bilirubin
Item
4. serum total bilirubin > 2 x uln, except in case of hemolytic anemia,
boolean
C1278039 (UMLS CUI [1])
serum potassium | serum magnesium
Item
5. k+ and mg2+ levels < lln, except if corrected per protocol guidance before beginning the romidepsin infusion
boolean
C0202194 (UMLS CUI [1])
C0373675 (UMLS CUI [2])
serum creatinine
Item
13. serum creatinine > 2.0 x uln
boolean
C0201976 (UMLS CUI [1])
medical history malignant neoplasms
Item
14. prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
informed consent unable
Item
15. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
cardiac abnormalities
Item
16. any known cardiac abnormalities such as:
boolean
C0018799 (UMLS CUI [1])
congenital long qt syndrome
Item
1. patients with congenital long qt syndrome
boolean
C1141890 (UMLS CUI [1])
corrrected qt interval
Item
2. corrected qt interval > 480 msec (using the fridericia formula)
boolean
C0577807 (UMLS CUI [1])
history ofmyocardial infarction
Item
3. myocardial infarction within 6 months of cycle 1 day 1
boolean
C1275835 (UMLS CUI [1])
medical history concomitant cardiovascular disease
Item
4. history of or concomitant significant cardiovascular disease
boolean
C0262926 (UMLS CUI [1,1])
C0007222 (UMLS CUI [1,2])
cardiac ejection fraction | muga scan | echocardiography
Item
5. ejection fraction <45% by muga scan or by echocardiogram;
boolean
C0232174 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
concomitant drugs prolonging qtc
Item
17. concomitant use of drugs that may cause a significant prolongation of the qtc
boolean
C1560305 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,3])
Doxorubicin
Item
18. patients who have received more than 200 mg/m2 doxorubicin
boolean
C0013089 (UMLS CUI [1])
cyp3a4 inhibitors
Item
19. concomitant use of strong cyp3a4 inhibitors
boolean
C3830624 (UMLS CUI [1])
warfarin
Item
20. concomitant use of therapeutic warfarin due to a potential drug interaction. use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted.
boolean
C0043031 (UMLS CUI [1])
clinically significant active infection
Item
21. clinically significant active infection
boolean
C0009450 (UMLS CUI [1])
standart anti-cancer drug | experimental anti-cancer drug
Item
22. use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (day 1) of study drug
boolean
C0920425 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
pregnancy | lactation | contraceptive use
Item
23. pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C1999124 (UMLS CUI [1,3])
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