ID

39593

Description

Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line; ODM derived from: https://clinicaltrials.gov/show/NCT01127841

Link

https://clinicaltrials.gov/show/NCT01127841

Keywords

Versions (1)
  1. 2/1/20 2/1/20 -
Copyright Holder

See clinicaltrials.gov

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February 1, 2020

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License

Creative Commons BY 4.0
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Eligibility Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line. NCT01127841

English

Eligibility Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line. NCT01127841

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥ 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with follicular lymphoma grade 1, 2 or 3a, cd20 +, histologically confirmed lymph node biopsy or tissue.
Description

Follicular Lymphoma CD20 antigen positive Ann Arbor lymphoma staging system | Biopsy of lymph node | Biopsy tissue

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C3888518
UMLS CUI [1,3]
C0432516
UMLS CUI [2]
C0193842
UMLS CUI [3]
C3864006
3. follicular lymphoma patients previously treated with the combination of rituximab and chemotherapy (r-chop, r-cvp, r-fludarabine), having received rituximab maintenance, refractory to a first line (excluding radiotherapy) or relapsed after having achieved any response to previous treatment.
Description

Lymphoma, Follicular | Combined Modality Therapy | rituximab | Chemotherapy | R-CHOP Regimen | R-CVP Regimen | Rituximab-Fludarabine Regimen | Rituximab Maintenance | Unresponsive to First line treatment | Exception Therapeutic radiology procedure | Recurrent disease | Status post Response Prior Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0024301
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0393022
UMLS CUI [4]
C3665472
UMLS CUI [5]
C0393023
UMLS CUI [6]
C1882520
UMLS CUI [7]
C1882526
UMLS CUI [8,1]
C0393022
UMLS CUI [8,2]
C0024501
UMLS CUI [9,1]
C0205269
UMLS CUI [9,2]
C1708063
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C1522449
UMLS CUI [11]
C0277556
UMLS CUI [12,1]
C0231290
UMLS CUI [12,2]
C1704632
UMLS CUI [12,3]
C1514463
4. ecog ≤ 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. signed written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinical suspicion or documentation of histological transformation.
Description

Suspicion Transformation Histological | Transformation Histological

Data type

boolean

Alias
UMLS CUI [1,1]
C0242114
UMLS CUI [1,2]
C0040682
UMLS CUI [1,3]
C0205462
UMLS CUI [2,1]
C0040682
UMLS CUI [2,2]
C0205462
2. patients with hypersensitivity to rituximab.
Description

Hypersensitivity Rituximab

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0393022
3. prior autologous or allogeneic transplant.
Description

Transplantation, Autologous | Transplantation, Homologous

Data type

boolean

Alias
UMLS CUI [1]
C0040736
UMLS CUI [2]
C0040739
4. cns infiltration by lf (primary cns lymphoma or lymphomatous meningitis).
Description

Central Nervous System Infiltration Follicular Lymphoma | Primary central nervous system lymphoma | Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C0332448
UMLS CUI [1,3]
C0024301
UMLS CUI [2]
C0280803
UMLS CUI [3]
C0220654
5. past or active hepatitis b (at least one of the following markers hbsag, hbe ag, anti-hbc, hbv dna).
Description

Hepatitis B | Markers Quantity | Hepatitis B Surface Antigens | Hepatitis B e Antigens | Anti-HBc antibody | Hepatitis B virus DNA

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0019168
UMLS CUI [4]
C0019167
UMLS CUI [5]
C0948759
UMLS CUI [6]
C0369332
6. hcv infection. hiv infection or other conditions of severe immunosuppression.
Description

Hepatitis C | HIV Infection | Immunosuppression Severe

Data type

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2]
C0019693
UMLS CUI [3,1]
C4048329
UMLS CUI [3,2]
C0205082
7. previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated.
Description

Malignant Neoplasms Previous | Exception Skin carcinoma | Exception Cervix carcinoma | Exception Malignant Neoplasm Treated

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0302592
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
UMLS CUI [4,3]
C1522326
8. congestive heart failure> nyha grade 1.
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
9. impaired renal function (creatinine> 1.5 x upper limit of normal, uln) or creatinine clearance <50 ml / h, not related to lymphoma.
Description

Renal Insufficiency | Creatinine increased | Creatinine clearance measurement | Relationship Absent Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0151578
UMLS CUI [3]
C0373595
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0024299
10. impaired liver function (bilirubin, ast / alt or ggt> 2 x uln) were not related to lymphoma.
Description

Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Relationship Absent Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0741494
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0151662
UMLS CUI [6,1]
C0439849
UMLS CUI [6,2]
C0332197
UMLS CUI [6,3]
C0024299
11. women who are nursing or pregnant.
Description

Breast Feeding | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
12. patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma.
Description

Heart Disease | Lung disease | Nervous system disorder | Mental disorders | Metabolic Disease Severe | Independent of Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0004936
UMLS CUI [5,1]
C0025517
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0332291
UMLS CUI [6,2]
C0024299
13. severe acute or chronic infection in activity.
Description

Communicable Disease Severe | Chronic infectious disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0151317
14. any other concurrent medical or psychological comorbidity that might interfere with participation in this study.
Description

Comorbidity Interferes with Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
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Similar models

Eligibility Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line. NCT01127841

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Follicular Lymphoma CD20 antigen positive Ann Arbor lymphoma staging system | Biopsy of lymph node | Biopsy tissue
Item
2. patients with follicular lymphoma grade 1, 2 or 3a, cd20 +, histologically confirmed lymph node biopsy or tissue.
boolean
C0024301 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
C0432516 (UMLS CUI [1,3])
C0193842 (UMLS CUI [2])
C3864006 (UMLS CUI [3])
Lymphoma, Follicular | Combined Modality Therapy | rituximab | Chemotherapy | R-CHOP Regimen | R-CVP Regimen | Rituximab-Fludarabine Regimen | Rituximab Maintenance | Unresponsive to First line treatment | Exception Therapeutic radiology procedure | Recurrent disease | Status post Response Prior Therapy
Item
3. follicular lymphoma patients previously treated with the combination of rituximab and chemotherapy (r-chop, r-cvp, r-fludarabine), having received rituximab maintenance, refractory to a first line (excluding radiotherapy) or relapsed after having achieved any response to previous treatment.
boolean
C0024301 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0393022 (UMLS CUI [3])
C3665472 (UMLS CUI [4])
C0393023 (UMLS CUI [5])
C1882520 (UMLS CUI [6])
C1882526 (UMLS CUI [7])
C0393022 (UMLS CUI [8,1])
C0024501 (UMLS CUI [8,2])
C0205269 (UMLS CUI [9,1])
C1708063 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C1522449 (UMLS CUI [10,2])
C0277556 (UMLS CUI [11])
C0231290 (UMLS CUI [12,1])
C1704632 (UMLS CUI [12,2])
C1514463 (UMLS CUI [12,3])
ECOG performance status
Item
4. ecog ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
5. signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Suspicion Transformation Histological | Transformation Histological
Item
1. clinical suspicion or documentation of histological transformation.
boolean
C0242114 (UMLS CUI [1,1])
C0040682 (UMLS CUI [1,2])
C0205462 (UMLS CUI [1,3])
C0040682 (UMLS CUI [2,1])
C0205462 (UMLS CUI [2,2])
Hypersensitivity Rituximab
Item
2. patients with hypersensitivity to rituximab.
boolean
C0020517 (UMLS CUI [1,1])
C0393022 (UMLS CUI [1,2])
Transplantation, Autologous | Transplantation, Homologous
Item
3. prior autologous or allogeneic transplant.
boolean
C0040736 (UMLS CUI [1])
C0040739 (UMLS CUI [2])
Central Nervous System Infiltration Follicular Lymphoma | Primary central nervous system lymphoma | Meningeal Carcinomatosis
Item
4. cns infiltration by lf (primary cns lymphoma or lymphomatous meningitis).
boolean
C3714787 (UMLS CUI [1,1])
C0332448 (UMLS CUI [1,2])
C0024301 (UMLS CUI [1,3])
C0280803 (UMLS CUI [2])
C0220654 (UMLS CUI [3])
Hepatitis B | Markers Quantity | Hepatitis B Surface Antigens | Hepatitis B e Antigens | Anti-HBc antibody | Hepatitis B virus DNA
Item
5. past or active hepatitis b (at least one of the following markers hbsag, hbe ag, anti-hbc, hbv dna).
boolean
C0019163 (UMLS CUI [1])
C0005516 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0019168 (UMLS CUI [3])
C0019167 (UMLS CUI [4])
C0948759 (UMLS CUI [5])
C0369332 (UMLS CUI [6])
Hepatitis C | HIV Infection | Immunosuppression Severe
Item
6. hcv infection. hiv infection or other conditions of severe immunosuppression.
boolean
C0019196 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C4048329 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Malignant Neoplasms Previous | Exception Skin carcinoma | Exception Cervix carcinoma | Exception Malignant Neoplasm Treated
Item
7. previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0302592 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Congestive heart failure New York Heart Association Classification
Item
8. congestive heart failure> nyha grade 1.
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Renal Insufficiency | Creatinine increased | Creatinine clearance measurement | Relationship Absent Lymphoma
Item
9. impaired renal function (creatinine> 1.5 x upper limit of normal, uln) or creatinine clearance <50 ml / h, not related to lymphoma.
boolean
C1565489 (UMLS CUI [1])
C0151578 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0439849 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0024299 (UMLS CUI [4,3])
Liver Dysfunction | Elevated total bilirubin | Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Relationship Absent Lymphoma
Item
10. impaired liver function (bilirubin, ast / alt or ggt> 2 x uln) were not related to lymphoma.
boolean
C0086565 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0151662 (UMLS CUI [5])
C0439849 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0024299 (UMLS CUI [6,3])
Breast Feeding | Pregnancy
Item
11. women who are nursing or pregnant.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Heart Disease | Lung disease | Nervous system disorder | Mental disorders | Metabolic Disease Severe | Independent of Lymphoma
Item
12. patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma.
boolean
C0018799 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0025517 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0332291 (UMLS CUI [6,1])
C0024299 (UMLS CUI [6,2])
Communicable Disease Severe | Chronic infectious disease
Item
13. severe acute or chronic infection in activity.
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0151317 (UMLS CUI [2])
Comorbidity Interferes with Study Subject Participation Status
Item
14. any other concurrent medical or psychological comorbidity that might interfere with participation in this study.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
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