ID

31755

Beschrijving

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

Trefwoorden

Versies (2)
  1. 26-09-18 26-09-18 -
  2. 26-09-18 26-09-18 -
Houder van rechten

See clinicaltrials.gov

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26 september 2018

DOI

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Creative Commons BY-NC 3.0
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Eligibility Relapsed Follicular Lymphoma NCT00715208

Engels

Eligibility Relapsed Follicular Lymphoma NCT00715208

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Recurrent disease Following Cancer treatment | Disease Progression Following Cancer treatment

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Central nervous system lymphoma Absent

Datatype

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)
Beschrijving

Karnofsky Performance Status | ECOG performance status

Datatype

boolean

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

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.
Beschrijving

Malignant Neoplasms | Cancer treatment | Exception Non-Hodgkin Lymphoma | Radiology marker Malignant Neoplasms | Biochemical Marker Malignant Neoplasms | 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

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024305
UMLS CUI [4,1]
C0181741
UMLS CUI [4,2]
C0006826
UMLS CUI [5,1]
C0206015
UMLS CUI [5,2]
C0006826
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:
Beschrijving

Therapeutic procedure

Datatype

boolean

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

Velcade

Datatype

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)
Beschrijving

Doxorubicin Cumulative Dose

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Nitrosoureas

Datatype

boolean

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

Radioimmunoconjugates

Datatype

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
Beschrijving

Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant

Datatype

boolean

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

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility Relapsed Follicular Lymphoma NCT00715208

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 | Radiology marker Malignant Neoplasms | Biochemical Marker Malignant Neoplasms | 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])
C0181741 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
C0206015 (UMLS CUI [5,1])
C0006826 (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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