ID

39093

Beschreibung

Safety and Efficacy of BKM120 in Relapsed and Refractory NHL; ODM derived from: https://clinicaltrials.gov/show/NCT01693614

Link

https://clinicaltrials.gov/show/NCT01693614

Stichworte

Versionen (1)
  1. 01.12.19 01.12.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

1. Dezember 2019

DOI

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Creative Commons BY 4.0
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Eligibility Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma NCT01693614

Englisch

Eligibility Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma NCT01693614

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient has a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large b cell lymphoma.
Beschreibung

Mantle cell lymphoma | Lymphoma, Follicular | Diffuse Large B-Cell Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0334634
UMLS CUI [2]
C0024301
UMLS CUI [3]
C0079744
2. patient has relapsed or refractory disease and received at least one prior therapy.
Beschreibung

Recurrent disease | Refractory Disease | Prior Therapy Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C1265611
3. patient with diffuse large b cell lymphoma has received or is ineligible for autologous or allogeneic stem cell transplant.
Beschreibung

Diffuse Large B-Cell Lymphoma | Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant | Patient Ineligible Autologous hematopoietic stem cell transplant | Patient Ineligible Allogeneic hematopoietic stem cell transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C0079744
UMLS CUI [2]
C2193200
UMLS CUI [3]
C4255274
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1512714
UMLS CUI [4,3]
C2193200
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C1512714
UMLS CUI [5,3]
C4255274
4. patient has at least one measurable nodal lesion (≥2 cm) according to cheson criteria (cheson 2007). in case where the patient has no measurable nodal lesions ≥ 2 cm in the long axis at baseline, then the patient must have at least one measurable extra-nodal lesion.
Beschreibung

Lesion nodal Quantity | Measurable lesion nodal Size | Measurable lesion Extranodal Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0443268
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0443268
UMLS CUI [2,3]
C0456389
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C1517067
UMLS CUI [3,3]
C1265611
5. patient has an eastern cooperative oncology group (ecog) performance status ≤ 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. patient has adequate bone marrow and organ function.
Beschreibung

Bone Marrow function | Organ function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0678852
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has received previous treatment with pi3k inhibitors
Beschreibung

PI3K inhibitor

Datentyp

boolean

Alias
UMLS CUI [1]
C1519050
2. patient has evidence of graft versus host disease (gvhd).
Beschreibung

Graft-vs-Host Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018133
3. patient has active or history of central nervous system (cns) disease.
Beschreibung

CNS disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0007682
4. patient has a concurrent malignancy or has a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).
Beschreibung

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Skin carcinoma Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
UMLS CUI [4,3]
C1522326
5. patient has a score ≥ 12 on the phq-9 questionnaire.
Beschreibung

Patient Health Questionnaire - 9 Item

Datentyp

boolean

Alias
UMLS CUI [1]
C4083201
6. patient has a gad-7 mood scale score ≥ 15.
Beschreibung

GAD-7

Datentyp

boolean

Alias
UMLS CUI [1]
C3641330
7. pregnant or nursing women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. patient who does not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.
Beschreibung

Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0332197
other protocol-defined inclusion/exclusion criteria may apply.
Beschreibung

Eligibility Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Ähnliche Modelle

Eligibility Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma NCT01693614

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Mantle cell lymphoma | Lymphoma, Follicular | Diffuse Large B-Cell Lymphoma
Item
1. patient has a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large b cell lymphoma.
boolean
C0334634 (UMLS CUI [1])
C0024301 (UMLS CUI [2])
C0079744 (UMLS CUI [3])
Recurrent disease | Refractory Disease | Prior Therapy Quantity
Item
2. patient has relapsed or refractory disease and received at least one prior therapy.
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C1514463 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Diffuse Large B-Cell Lymphoma | Autologous hematopoietic stem cell transplant | Allogeneic hematopoietic stem cell transplant | Patient Ineligible Autologous hematopoietic stem cell transplant | Patient Ineligible Allogeneic hematopoietic stem cell transplant
Item
3. patient with diffuse large b cell lymphoma has received or is ineligible for autologous or allogeneic stem cell transplant.
boolean
C0079744 (UMLS CUI [1])
C2193200 (UMLS CUI [2])
C4255274 (UMLS CUI [3])
C0030705 (UMLS CUI [4,1])
C1512714 (UMLS CUI [4,2])
C2193200 (UMLS CUI [4,3])
C0030705 (UMLS CUI [5,1])
C1512714 (UMLS CUI [5,2])
C4255274 (UMLS CUI [5,3])
Lesion nodal Quantity | Measurable lesion nodal Size | Measurable lesion Extranodal Quantity
Item
4. patient has at least one measurable nodal lesion (≥2 cm) according to cheson criteria (cheson 2007). in case where the patient has no measurable nodal lesions ≥ 2 cm in the long axis at baseline, then the patient must have at least one measurable extra-nodal lesion.
boolean
C0221198 (UMLS CUI [1,1])
C0443268 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0443268 (UMLS CUI [2,2])
C0456389 (UMLS CUI [2,3])
C1513041 (UMLS CUI [3,1])
C1517067 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
ECOG performance status
Item
5. patient has an eastern cooperative oncology group (ecog) performance status ≤ 2.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Organ function
Item
6. patient has adequate bone marrow and organ function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
PI3K inhibitor
Item
1. patient has received previous treatment with pi3k inhibitors
boolean
C1519050 (UMLS CUI [1])
Graft-vs-Host Disease
Item
2. patient has evidence of graft versus host disease (gvhd).
boolean
C0018133 (UMLS CUI [1])
CNS disorder
Item
3. patient has active or history of central nervous system (cns) disease.
boolean
C0007682 (UMLS CUI [1])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Skin carcinoma Treated
Item
4. patient has a concurrent malignancy or has a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Patient Health Questionnaire - 9 Item
Item
5. patient has a score ≥ 12 on the phq-9 questionnaire.
boolean
C4083201 (UMLS CUI [1])
GAD-7
Item
6. patient has a gad-7 mood scale score ≥ 15.
boolean
C3641330 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
7. pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Absent
Item
8. patient who does not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.
boolean
C0700589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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