ID

31767

Description

Phase 2 Study of VELCADE (Bortezomib) in Patients With Relapsed Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00715208

Link

https://clinicaltrials.gov/show/NCT00715208

Keywords

Versions (2)
  1. 9/26/18 9/26/18 -
  2. 9/26/18 9/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 26, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Relapsed Follicular Lymphoma NCT00715208

English

Eligibility Relapsed Follicular Lymphoma NCT00715208

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pathological diagnosis of follicular lymphoma (any grade) or marginal zone lymphoma. patients with transformed follicular lymphoma are eligible, provided there has previously been pathologic documentation of follicular lymphoma.
Description

Follicular Lymphoma Ann Arbor lymphoma staging system | Marginal Zone Lymphoma | Follicular Lymphoma transformed

Data type

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0432516
UMLS CUI [2]
C1367654
UMLS CUI [3,1]
C0024301
UMLS CUI [3,2]
C1510411
documented relapse or progression following prior antineoplastic therapy
Description

Recurrent disease Following Cancer treatment | Disease Progression Following Cancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0920425
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C0920425
at least 1 measurable tumor mass that is greater than 1.5 cm in the long axis and greater than 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 Size Long axis | Tumor Mass Size Short axis | Prior radiation therapy Absent | Tumor Mass Increased size Since 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]
C0456389
UMLS CUI [2,3]
C0522487
UMLS CUI [3,1]
C3273930
UMLS CUI [3,2]
C0456389
UMLS CUI [3,3]
C0522488
UMLS CUI [4,1]
C0279134
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C3273930
UMLS CUI [5,2]
C0332509
UMLS CUI [5,3]
C1711239
UMLS CUI [5,4]
C0279134
no clinically significant evidence of active 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. patients with prostate cancer who were treated with definitive radiotherapy who have a serum prostate-specific antigen <1 ng/ml are not excluded. patients are 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 | Malignant Neoplasms Radiology marker | Malignant Neoplasms Biochemical Marker | 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]
C0006826
UMLS CUI [4,2]
C0181741
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0206015
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1522449
UMLS CUI [6,3]
C0600139
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0201544
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0015250
UMLS CUI [8,3]
C0007117
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0015250
UMLS CUI [9,3]
C0553723
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0007099
UMLS CUI [10,3]
C1522326
received any of the following treatments or procedures outside of the specified timeframes:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
prior treatment with velcade
Description

Velcade

Data type

boolean

Alias
UMLS CUI [1]
C1174739
prior treatment with a cumulative dose of doxorubicin of more than 100 mg/m2, if assigned to arm a (velcade-r-cap)
Description

Doxorubicin Cumulative Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
antineoplastic (including unconjugated therapeutic antibodies and toxin immunoconjugates), experimental, or radiation therapy within 3 weeks before day 1 of cycle 1
Description

Antineoplastic Drug/Agent Therapy | Monoclonal antibody unconjugated therapy | Immunoconjugates | Therapies, Investigational | Therapeutic radiology procedure

Data type

boolean

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

Nitrosoureas

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

Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C2193200
UMLS CUI [2]
C4255274
major surgery within 2 weeks before day 1 of cycle 1
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility Relapsed Follicular Lymphoma NCT00715208

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patient 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Follicular Lymphoma Ann Arbor lymphoma staging system | Marginal Zone Lymphoma | Follicular Lymphoma transformed
Item
pathological diagnosis of follicular lymphoma (any grade) or marginal zone lymphoma. patients with transformed follicular lymphoma are eligible, provided there has previously been pathologic documentation of follicular lymphoma.
boolean
C0024301 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
C1367654 (UMLS CUI [2])
C0024301 (UMLS CUI [3,1])
C1510411 (UMLS CUI [3,2])
Recurrent disease Following Cancer treatment | Disease Progression Following Cancer treatment
Item
documented relapse or progression following prior antineoplastic therapy
boolean
C0277556 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C0920425 (UMLS CUI [2,3])
Tumor Mass Measurable Quantity | Tumor Mass Size Long axis | Tumor Mass Size Short axis | Prior radiation therapy Absent | Tumor Mass Increased size Since Prior radiation therapy
Item
at least 1 measurable tumor mass that is greater than 1.5 cm in the long axis and greater than 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])
C0456389 (UMLS CUI [2,2])
C0522487 (UMLS CUI [2,3])
C3273930 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0522488 (UMLS CUI [3,3])
C0279134 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C3273930 (UMLS CUI [5,1])
C0332509 (UMLS CUI [5,2])
C1711239 (UMLS CUI [5,3])
C0279134 (UMLS CUI [5,4])
Central nervous system lymphoma Absent
Item
no clinically significant evidence of active 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 | Malignant Neoplasms Radiology marker | Malignant Neoplasms Biochemical Marker | 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. patients with prostate cancer who were treated with definitive radiotherapy who have a serum prostate-specific antigen <1 ng/ml are not excluded. patients are 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])
C0006826 (UMLS CUI [4,1])
C0181741 (UMLS CUI [4,2])
C0006826 (UMLS CUI [5,1])
C0206015 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C1522449 (UMLS CUI [6,2])
C0600139 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0201544 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0015250 (UMLS CUI [8,2])
C0007117 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0015250 (UMLS CUI [9,2])
C0553723 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0007099 (UMLS CUI [10,2])
C1522326 (UMLS CUI [10,3])
Therapeutic procedure
Item
received any of the following treatments or procedures outside of the specified timeframes:
boolean
C0087111 (UMLS CUI [1])
Velcade
Item
prior treatment with velcade
boolean
C1174739 (UMLS CUI [1])
Doxorubicin Cumulative Dose
Item
prior treatment with a cumulative dose of doxorubicin of more than 100 mg/m2, if assigned to arm a (velcade-r-cap)
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Antineoplastic Drug/Agent Therapy | Monoclonal antibody unconjugated therapy | 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])
C0243020 (UMLS CUI [3])
C0949266 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Nitrosoureas
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])
Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant
Item
autologous stem cell transplant within 3 months before day 1 of cycle 1, or prior allogeneic stem cell transplant at any time
boolean
C2193200 (UMLS CUI [1])
C4255274 (UMLS CUI [2])
Major surgery
Item
major surgery within 2 weeks before day 1 of cycle 1
boolean
C0679637 (UMLS CUI [1])
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