ID

29377

Description

A Phase II Study of VELCADE (Bortezomib) in Combination With Bendamustine and Rituximab in Subjects With Relapsed or Refractory Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00636792

Link

https://clinicaltrials.gov/show/NCT00636792

Keywords

Versions (1)
  1. 3/21/18 3/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT00636792

English

Eligibility Follicular Lymphoma NCT00636792

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female subject 18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pathological diagnosis of follicular lymphoma (any grade)
Description

Follicular Lymphoma Grade Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C1552551
documented relapse or progression following prior antineoplastic therapy
Description

Recurrent disease Post Antineoplastic Therapy | Disease Progression Post Antineoplastic Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C2346834
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C2346834
have received 4 or more prior doses of rituximab
Description

Rituximab Dose Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1265611
at least 1 measurable tumor mass (>1.5 cm in the long axis and >1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation
Description

Tumor Mass Measurable Quantity | Tumor Mass Long axis | Tumor Mass Short axis | Prior radiation therapy Absent | Tumor growth Post Prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3273930
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3273930
UMLS CUI [2,2]
C0522487
UMLS CUI [3,1]
C3273930
UMLS CUI [3,2]
C0522488
UMLS CUI [4,1]
C0279134
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0598934
UMLS CUI [5,2]
C0687676
UMLS CUI [5,3]
C0279134
no clinically significant central nervous system lymphoma
Description

Central nervous system lymphoma Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0742472
UMLS CUI [1,2]
C0332197
karnofsky performance status (kps) ≥50 (equivalent to eastern cooperative group oncology group [ecog] status ≤2
Description

Karnofsky Performance Status | ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosed or treated for a malignancy other than non-hodgkin's lymphoma (nhl) within 2 years of first dose, or who were previously diagnosed with a malignancy other than nhl and have any radiographic or biochemical marker evidence of malignancy. subjects with prostate cancer who were treated with definitive radiotherapy and have a serum prostate-specific antigen (psa) <1 ng/ml are not excluded. subjects are also not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in situ malignancy that was adequately treated.
Description

Malignant Neoplasms | Cancer treatment | Exception Non-Hodgkin Lymphoma | Exception Therapeutic radiology procedure Prostate carcinoma | Exception Prostate specific antigen measurement | Exception Complete excision Basal cell carcinoma | Exception Complete excision Squamous cell carcinoma of skin | Exception Carcinoma in Situ Treated

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024305
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1522449
UMLS CUI [4,3]
C0600139
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0201544
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0015250
UMLS CUI [6,3]
C0007117
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0015250
UMLS CUI [7,3]
C0553723
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0007099
UMLS CUI [8,3]
C1522326
prior treatment with velcade® or bendamustine
Description

Velcade | Bendamustine

Data type

boolean

Alias
UMLS CUI [1]
C1174739
UMLS CUI [2]
C0525079
antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before day 1 of cycle 1
Description

Antineoplastic Therapy | Monoclonal antibody unconjugated therapy | Toxin Immunoconjugates | Therapies, Investigational | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C2346834
UMLS CUI [2]
C0854644
UMLS CUI [3,1]
C0040549
UMLS CUI [3,2]
C0243020
UMLS CUI [4]
C0949266
UMLS CUI [5]
C1522449
nitrosoureas within 6 weeks before day 1 of cycle 1
Description

Nitrosourea

Data type

boolean

Alias
UMLS CUI [1]
C0028210
radioimmunoconjugates within 10 weeks before day 1 of cycle 1
Description

Radioimmunoconjugates

Data type

boolean

Alias
UMLS CUI [1]
C0243019
autologous stem cell transplant within 3 months before day 1 of cycle 1, or prior allogeneic stem cell transplant at any time
Description

Transplantation of autologous hematopoietic stem cell | Allogeneic Stem Cell Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C1831743
UMLS CUI [2]
C2242529
major surgery within 2 weeks before day 1 of cycle 1
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
platelet transfusion within 7 days of day 1 of cycle 1 (applies to subjects enrolled in the dose escalation phase only. this does not apply to subjects enrolled in phase 2 of the study).
Description

Platelet Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0086818
ongoing therapy with corticosteroids. prednisone ≤15 mg per day or its equivalent is allowed.
Description

Steroid therapy | Prednisone U/day allowed | Prednisone Equivalent allowed

Data type

boolean

Alias
UMLS CUI [1]
C0149783
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C0205163
UMLS CUI [3,3]
C0683607
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Similar models

Eligibility Follicular Lymphoma NCT00636792

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female subject 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Follicular Lymphoma Grade Any
Item
pathological diagnosis of follicular lymphoma (any grade)
boolean
C0024301 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Recurrent disease Post Antineoplastic Therapy | Disease Progression Post Antineoplastic Therapy
Item
documented relapse or progression following prior antineoplastic therapy
boolean
C0277556 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C2346834 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C2346834 (UMLS CUI [2,3])
Rituximab Dose Quantity
Item
have received 4 or more prior doses of rituximab
boolean
C0393022 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Tumor Mass Measurable Quantity | Tumor Mass Long axis | Tumor Mass Short axis | Prior radiation therapy Absent | Tumor growth Post Prior radiation therapy
Item
at least 1 measurable tumor mass (>1.5 cm in the long axis and >1.0 cm in the short axis that has not been previously irradiated, or has grown since previous irradiation
boolean
C3273930 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3273930 (UMLS CUI [2,1])
C0522487 (UMLS CUI [2,2])
C3273930 (UMLS CUI [3,1])
C0522488 (UMLS CUI [3,2])
C0279134 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0598934 (UMLS CUI [5,1])
C0687676 (UMLS CUI [5,2])
C0279134 (UMLS CUI [5,3])
Central nervous system lymphoma Absent
Item
no clinically significant central nervous system lymphoma
boolean
C0742472 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Karnofsky Performance Status | ECOG performance status
Item
karnofsky performance status (kps) ≥50 (equivalent to eastern cooperative group oncology group [ecog] status ≤2
boolean
C0206065 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Cancer treatment | Exception Non-Hodgkin Lymphoma | Exception Therapeutic radiology procedure Prostate carcinoma | Exception Prostate specific antigen measurement | Exception Complete excision Basal cell carcinoma | Exception Complete excision Squamous cell carcinoma of skin | Exception Carcinoma in Situ Treated
Item
diagnosed or treated for a malignancy other than non-hodgkin's lymphoma (nhl) within 2 years of first dose, or who were previously diagnosed with a malignancy other than nhl and have any radiographic or biochemical marker evidence of malignancy. subjects with prostate cancer who were treated with definitive radiotherapy and have a serum prostate-specific antigen (psa) <1 ng/ml are not excluded. subjects are also not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in situ malignancy that was adequately treated.
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0024305 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
C0600139 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0201544 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0015250 (UMLS CUI [6,2])
C0007117 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0015250 (UMLS CUI [7,2])
C0553723 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0007099 (UMLS CUI [8,2])
C1522326 (UMLS CUI [8,3])
Velcade | Bendamustine
Item
prior treatment with velcade® or bendamustine
boolean
C1174739 (UMLS CUI [1])
C0525079 (UMLS CUI [2])
Antineoplastic Therapy | Monoclonal antibody unconjugated therapy | Toxin Immunoconjugates | Therapies, Investigational | Therapeutic radiology procedure
Item
antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before day 1 of cycle 1
boolean
C2346834 (UMLS CUI [1])
C0854644 (UMLS CUI [2])
C0040549 (UMLS CUI [3,1])
C0243020 (UMLS CUI [3,2])
C0949266 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Nitrosourea
Item
nitrosoureas within 6 weeks before day 1 of cycle 1
boolean
C0028210 (UMLS CUI [1])
Radioimmunoconjugates
Item
radioimmunoconjugates within 10 weeks before day 1 of cycle 1
boolean
C0243019 (UMLS CUI [1])
Transplantation of autologous hematopoietic stem cell | Allogeneic Stem Cell Transplantation
Item
autologous stem cell transplant within 3 months before day 1 of cycle 1, or prior allogeneic stem cell transplant at any time
boolean
C1831743 (UMLS CUI [1])
C2242529 (UMLS CUI [2])
Major surgery
Item
major surgery within 2 weeks before day 1 of cycle 1
boolean
C0679637 (UMLS CUI [1])
Platelet Transfusion
Item
platelet transfusion within 7 days of day 1 of cycle 1 (applies to subjects enrolled in the dose escalation phase only. this does not apply to subjects enrolled in phase 2 of the study).
boolean
C0086818 (UMLS CUI [1])
Steroid therapy | Prednisone U/day allowed | Prednisone Equivalent allowed
Item
ongoing therapy with corticosteroids. prednisone ≤15 mg per day or its equivalent is allowed.
boolean
C0149783 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0032952 (UMLS CUI [3,1])
C0205163 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
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