ID

15383

Beskrivning

Cord Blood Natural Killer (NK) Cells in Chronic Lymphocytic Leukemia (CLL); ODM derived from: https://clinicaltrials.gov/show/NCT02280525

Länk

https://clinicaltrials.gov/show/NCT02280525

Nyckelord

Versioner (1)
  1. 2016-05-29 2016-05-29 -
Uppladdad den

29 maj 2016

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia NCT02280525

Engelsk

Eligibility Leukemia NCT02280525

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02280525
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with history of b-cll who have received at least 2 lines of standard chemoimmunotherapy and have persistent disease.
Beskrivning

Chronic Lymphocytic Leukemia | Chemoimmunotherapy Standard | Persistent Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0023434
UMLS CUI [2,1]
C2986423
UMLS CUI [2,2]
C1442989
UMLS CUI [3]
C2983415
2. patients with acute lymphoblastic leukemia (all), acute myelogenous leukemia (aml), chronic myelogenous leukemia (cml) with relapsed or refractory disease.
Beskrivning

Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Myeloid Leukemia, Chronic | Recurrent disease | Refractory Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0023449
UMLS CUI [2]
C0023467
UMLS CUI [3]
C0023473
UMLS CUI [4]
C0277556
UMLS CUI [5]
C1514815
3. patients with histologically confirmed aggressive b cell nhl with chemotherapy-refractory disease. chemotherapy refractory disease is defined as one or more of the following: stable disease or progressive disease as best response to most recent chemotherapy containing regimen or disease progression or recurrence within 12 months of prior autologous or allogeneic stem cell transplant. subjects must have received adequate prior therapy including at a minimum: anti-cd20 monoclonal antibody unless tumor is cd20-negative, an anthracycline containing chemotherapy regimen. subjects with transformed fl must have received prior chemotherapy for follicular lymphoma and subsequently have chemo-refractory disease after transformation to diffuse large b-cell lymphoma (dlbcl).
Beskrivning

B-Cell Lymphomas | Chemotherapy Regimen | Refractory Disease | autologous hematopoietic stem cell transplant | allogenic hematopoietic stem cell transplant | rituximab | Chemotherapy Regimen Anthracyclines | Lymphoma, Follicular | Diffuse Large B-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0079731
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1514815
UMLS CUI [4]
C2193200
UMLS CUI [5]
C1456094
UMLS CUI [6]
C0393022
UMLS CUI [7,1]
C0392920
UMLS CUI [7,2]
C0282564
UMLS CUI [8]
C0024301
UMLS CUI [9]
C0079744
4. patient with hodgkin's lymphoma with relapsed or refractory disease.
Beskrivning

Hodgkin Disease | Recurrent disease | Refractory Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0019829
UMLS CUI [2]
C0277556
UMLS CUI [3]
C1514815
5. patients who are at least 3 weeks from the time of consent. patients may continue ibrutinib, idelalisib, or lenalidomide till the day of study consent.
Beskrivning

Ibrutinib | idelalisib | lenalidomide

Datatyp

boolean

Alias
UMLS CUI [1]
C3501358
UMLS CUI [2]
C2698692
UMLS CUI [3]
C1144149
6. karnofsky performance scale > 60%.
Beskrivning

Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0206065
7. adequate hepatic function, as defined by sgpt <3 x upper limit of normal; serum bilirubin and alkaline phosphatase <2 x upper limit of normal, or considered not clinically significant by the study doctor or designee, serum creatinine of </=2 mg/dl.
Beskrivning

Liver function | Alanine aminotransferase measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201850
UMLS CUI [5]
C0201976
8. able to provide written informed consent.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
9. 18-80 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
10. all study participants must be registered into the mandatory revlimid remstm program, and be willing and able to comply with the requirements of the revlimid remstm program. females of childbearing potential must adhere to the scheduled pregnancy testing and contraception as required in the revlimid remstm program. a female of childbearing potential (fcbp) is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Beskrivning

Revlimid Program | Compliance behavior | Childbearing Potential Pregnancy Test Contraceptive methods | Hysterectomy | Bilateral oophorectomy | Postmenopausal state | Menstruation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1135145
UMLS CUI [1,2]
C3484370
UMLS CUI [2]
C1321605
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032976
UMLS CUI [3,3]
C0700589
UMLS CUI [4]
C0020699
UMLS CUI [5]
C0278321
UMLS CUI [6]
C0232970
UMLS CUI [7]
C0025344
11. men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy.
Beskrivning

Gender | Latex condom Use | Vasectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3873750
UMLS CUI [2,2]
C1524063
UMLS CUI [3]
C0042387
12. patients must have a cb unit available which is matched with the patient at 3, 4, 5, or 6/6 hla class i (serological) and ii (molecular) antigens.
Beskrivning

Umbilical Cord Blood Units Availability | Human Class I Antigens Serological | HLA class II antigen Molecular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162371
UMLS CUI [1,2]
C0439184
UMLS CUI [1,3]
C0470187
UMLS CUI [2,1]
C0008897
UMLS CUI [2,2]
C0205473
UMLS CUI [3,1]
C0312653
UMLS CUI [3,2]
C1521991
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. positive beta hcg in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
Beskrivning

Beta HCG positive | Childbearing Potential | Postmenopausal state | Female Sterilization | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0813152
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0006147
2. known positive serology for hiv.
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
3. presence of grade 3 or greater toxicity from the previous treatment.
Beskrivning

Toxicity Grade Due to Prior Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2826262
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514463
4. concomitant use of other investigational agents.
Beskrivning

Investigational New Drugs Other Simultaneous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0521115
5. not consenting to participate in lab00-099.
Beskrivning

Laboratory Procedure Participation Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0558080
6. patients with known hypersensitivity to lenalidomide and/or rituximab.
Beskrivning

Hypersensitivity lenalidomide | Hypersensitivity rituximab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1144149
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0393022
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Similar models

Eligibility Leukemia NCT02280525

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT02280525
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Lymphocytic Leukemia | Chemoimmunotherapy Standard | Persistent Disease
Item
1. patients with history of b-cll who have received at least 2 lines of standard chemoimmunotherapy and have persistent disease.
boolean
C0023434 (UMLS CUI [1])
C2986423 (UMLS CUI [2,1])
C1442989 (UMLS CUI [2,2])
C2983415 (UMLS CUI [3])
Acute lymphocytic leukemia | Leukemia, Myelocytic, Acute | Myeloid Leukemia, Chronic | Recurrent disease | Refractory Disease
Item
2. patients with acute lymphoblastic leukemia (all), acute myelogenous leukemia (aml), chronic myelogenous leukemia (cml) with relapsed or refractory disease.
boolean
C0023449 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C0023473 (UMLS CUI [3])
C0277556 (UMLS CUI [4])
C1514815 (UMLS CUI [5])
B-Cell Lymphomas | Chemotherapy Regimen | Refractory Disease | autologous hematopoietic stem cell transplant | allogenic hematopoietic stem cell transplant | rituximab | Chemotherapy Regimen Anthracyclines | Lymphoma, Follicular | Diffuse Large B-Cell Lymphoma
Item
3. patients with histologically confirmed aggressive b cell nhl with chemotherapy-refractory disease. chemotherapy refractory disease is defined as one or more of the following: stable disease or progressive disease as best response to most recent chemotherapy containing regimen or disease progression or recurrence within 12 months of prior autologous or allogeneic stem cell transplant. subjects must have received adequate prior therapy including at a minimum: anti-cd20 monoclonal antibody unless tumor is cd20-negative, an anthracycline containing chemotherapy regimen. subjects with transformed fl must have received prior chemotherapy for follicular lymphoma and subsequently have chemo-refractory disease after transformation to diffuse large b-cell lymphoma (dlbcl).
boolean
C0079731 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
C2193200 (UMLS CUI [4])
C1456094 (UMLS CUI [5])
C0393022 (UMLS CUI [6])
C0392920 (UMLS CUI [7,1])
C0282564 (UMLS CUI [7,2])
C0024301 (UMLS CUI [8])
C0079744 (UMLS CUI [9])
Hodgkin Disease | Recurrent disease | Refractory Disease
Item
4. patient with hodgkin's lymphoma with relapsed or refractory disease.
boolean
C0019829 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C1514815 (UMLS CUI [3])
Ibrutinib | idelalisib | lenalidomide
Item
5. patients who are at least 3 weeks from the time of consent. patients may continue ibrutinib, idelalisib, or lenalidomide till the day of study consent.
boolean
C3501358 (UMLS CUI [1])
C2698692 (UMLS CUI [2])
C1144149 (UMLS CUI [3])
Karnofsky Performance Status
Item
6. karnofsky performance scale > 60%.
boolean
C0206065 (UMLS CUI [1])
Liver function | Alanine aminotransferase measurement | Serum total bilirubin measurement | Alkaline phosphatase measurement | Creatinine measurement, serum
Item
7. adequate hepatic function, as defined by sgpt <3 x upper limit of normal; serum bilirubin and alkaline phosphatase <2 x upper limit of normal, or considered not clinically significant by the study doctor or designee, serum creatinine of </=2 mg/dl.
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0201976 (UMLS CUI [5])
Informed consent
Item
8. able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
9. 18-80 years of age.
boolean
C0001779 (UMLS CUI [1])
Revlimid Program | Compliance behavior | Childbearing Potential Pregnancy Test Contraceptive methods | Hysterectomy | Bilateral oophorectomy | Postmenopausal state | Menstruation
Item
10. all study participants must be registered into the mandatory revlimid remstm program, and be willing and able to comply with the requirements of the revlimid remstm program. females of childbearing potential must adhere to the scheduled pregnancy testing and contraception as required in the revlimid remstm program. a female of childbearing potential (fcbp) is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
boolean
C1135145 (UMLS CUI [1,1])
C3484370 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0020699 (UMLS CUI [4])
C0278321 (UMLS CUI [5])
C0232970 (UMLS CUI [6])
C0025344 (UMLS CUI [7])
Gender | Latex condom Use | Vasectomy
Item
11. men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy.
boolean
C0079399 (UMLS CUI [1])
C3873750 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0042387 (UMLS CUI [3])
Umbilical Cord Blood Units Availability | Human Class I Antigens Serological | HLA class II antigen Molecular
Item
12. patients must have a cb unit available which is matched with the patient at 3, 4, 5, or 6/6 hla class i (serological) and ii (molecular) antigens.
boolean
C0162371 (UMLS CUI [1,1])
C0439184 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0008897 (UMLS CUI [2,1])
C0205473 (UMLS CUI [2,2])
C0312653 (UMLS CUI [3,1])
C1521991 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Beta HCG positive | Childbearing Potential | Postmenopausal state | Female Sterilization | Breast Feeding
Item
1. positive beta hcg in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
boolean
C0813152 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
HIV Seropositivity
Item
2. known positive serology for hiv.
boolean
C0019699 (UMLS CUI [1])
Toxicity Grade Due to Prior Therapy
Item
3. presence of grade 3 or greater toxicity from the previous treatment.
boolean
C2826262 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
Investigational New Drugs Other Simultaneous
Item
4. concomitant use of other investigational agents.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0521115 (UMLS CUI [1,3])
Laboratory Procedure Participation Unwilling
Item
5. not consenting to participate in lab00-099.
boolean
C0022885 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Hypersensitivity lenalidomide | Hypersensitivity rituximab
Item
6. patients with known hypersensitivity to lenalidomide and/or rituximab.
boolean
C0020517 (UMLS CUI [1,1])
C1144149 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0393022 (UMLS CUI [2,2])
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