ID

11991

Beschreibung

Safety & Efficacy of Lamivudine & Tenofovir to Lower Plasma Level of Viral RNA in Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01528865 Principal Investigator: Scott D Gitlin, MD

Link

https://clinicaltrials.gov/show/NCT01528865

Stichworte

Versionen (1)
  1. 30.08.15 30.08.15 -
Hochgeladen am

30. August 2015

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma NCT01528865

Englisch

Eligibility Lymphoma NCT01528865

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01528865
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Patients must have a histologically confirmed diagnosis of non-Hodgkin lymphoma (NHL)
Beschreibung

Patients must have a histologically confirmed diagnosis of non-Hodgkin lymphoma (NHL)

Datentyp

boolean

Alias
UMLS CUI [1]
C0024305
UMLS CUI [2]
C0011900
Must have HERV-K(HML2) viral load of ≥1x103 using a gag primer reverse transcriptase polymerase chain reaction (RT-PCR) assay.
Beschreibung

Must have HERV-K(HML2) viral load of ≥1x103 using a gag primer reverse transcriptase polymerase chain reaction (RT-PCR) assay

Datentyp

boolean

Alias
UMLS CUI [1]
C1012096
UMLS CUI [2]
C0599161
Must have bi-dimensionally measurable disease.
Beschreibung

Must have bi-dimensionally measurable disease.

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
Patients with lymphomas that are felt to be incurable with any therapy and for whom there are no standard treatments that would be anticipated to be necessary or beneficial within the next 5 months. These patients can have received any amount of prior chemotherapy to enter this trial.
Beschreibung

Patients with lymphomas that are felt to be incurable with any therapy and for whom there are no standard treatments that would be anticipated to be necessary or beneficial within the next 5 months. These patients can have received any amount of prior chemotherapy to enter this trial.

Datentyp

boolean

Alias
UMLS CUI [1]
C0024299
UMLS CUI [2]
C0175969
All previous therapies must have been discontinued at least 4 weeks prior to initiation of the administration of this study's drugs.
Beschreibung

All previous therapies must have been discontinued at least 4 weeks prior to initiation of the administration of this study's drugs.

Datentyp

boolean

Alias
UMLS CUI [1]
C0677162
HIV negative by standard blood testing.
Beschreibung

HIV negative by standard blood testing.

Datentyp

boolean

Alias
UMLS CUI [1]
C0481430
Have an expected life expectancy of at least 5 months.
Beschreibung

Have an expected life expectancy of at least 5 months.

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Have an Eastern Cooperative Oncology Group (ECOG) performance scale status of 0 - 2l) Must have a serum creatinine <2.0 and creatinine clearance >30 ml/min/m2. Other organ dysfunction is eligible at the discretion of the PI.
Beschreibung

Have an Eastern Cooperative Oncology Group (ECOG) performance scale status of 0 - 2l) Must have a serum creatinine <2.0 and creatinine clearance >30 ml/min/m2. Other organ dysfunction is eligible at the discretion of the PI.

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0600061
UMLS CUI [3]
C0812399
Agree to use a reliable method of birth control prior to drug initiation and for the duration of their study participation.
Beschreibung

Agree to use a reliable method of birth control prior to drug initiation and for the duration of their study participation.

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
a) Have received chemotherapy or radiotherapy within 4 weeks
Beschreibung

chemotherapy; radiotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C3665472
UMLS CUI [2]
C1522449
Have not recovered from the adverse effects or toxicities of lymphoma therapy most recently administered.
Beschreibung

Have not recovered from the adverse effects or toxicities of lymphoma therapy most recently administered.

Datentyp

boolean

Alias
UMLS CUI [1]
C0879626
UMLS CUI [2]
C0087111
Currently receiving any other investigational medication or therapy.
Beschreibung

Currently receiving any other investigational medication or therapy.

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
Patients with a second malignancy that might interfere with interpretation of the results of this study.
Beschreibung

Patients with a second malignancy that might interfere with interpretation of the results of this study.

Datentyp

boolean

Alias
UMLS CUI [1]
C0085183
Patients with known allergic reaction to lamivudine or tenofovir disoproxil fumarate (DF).
Beschreibung

Patients with known allergic reaction to lamivudine or tenofovir disoproxil fumarate (DF).

Datentyp

boolean

Alias
UMLS CUI [1]
C1527304
UMLS CUI [2]
C1099776
Patients on drugs that interfere with renal function or drugs that compete with tenofovir for active binding sites (i.e. intravenous cidofovir, acyclovir, ganciclovir, and valganciclovir).
Beschreibung

Patients on drugs that interfere with renal function or drugs that compete with tenofovir for active binding sites (i.e. intravenous cidofovir, acyclovir, ganciclovir, and valganciclovir).

Datentyp

boolean

Alias
UMLS CUI [1]
C1547774
UMLS CUI [2]
C0232804
Uncontrolled concurrent illnesses, including, but not limited to, active/ongoing infection, symptomatic congestive heart failure, unstable angina pectoris.
Beschreibung

Uncontrolled concurrent illnesses, including, but not limited to, active/ongoing infection, symptomatic congestive heart failure, unstable angina pectoris.

Datentyp

boolean

Alias
UMLS CUI [1]
C0205420
UMLS CUI [2]
C0012634
Women who are pregnant, become pregnant, or are breast-feeding.
Beschreibung

Women who are pregnant, become pregnant, or are breast-feeding.

Datentyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
Standard blood tests that are positive for HIV infection
Beschreibung

Standard blood tests that are positive for HIV infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0745002
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Ähnliche Modelle

Eligibility Lymphoma NCT01528865

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT01528865
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
non-Hodgkin lymphoma (NHL); Diagnosis
Item
Patients must have a histologically confirmed diagnosis of non-Hodgkin lymphoma (NHL)
boolean
C0024305 (UMLS CUI [1])
C0011900 (UMLS CUI [2])
Human endogenous retrovirus K; Reverse Transcriptase Polymerase Chain Reaction
Item
Must have HERV-K(HML2) viral load of ≥1x103 using a gag primer reverse transcriptase polymerase chain reaction (RT-PCR) assay.
boolean
C1012096 (UMLS CUI [1])
C0599161 (UMLS CUI [2])
measurable disease
Item
Must have bi-dimensionally measurable disease.
boolean
C1513041 (UMLS CUI [1])
Lymphoma ;incurable diseases
Item
Patients with lymphomas that are felt to be incurable with any therapy and for whom there are no standard treatments that would be anticipated to be necessary or beneficial within the next 5 months. These patients can have received any amount of prior chemotherapy to enter this trial.
boolean
C0024299 (UMLS CUI [1])
C0175969 (UMLS CUI [2])
Recommend therapy discontinuation
Item
All previous therapies must have been discontinued at least 4 weeks prior to initiation of the administration of this study's drugs.
boolean
C0677162 (UMLS CUI [1])
HIV negative
Item
HIV negative by standard blood testing.
boolean
C0481430 (UMLS CUI [1])
life expectancy
Item
Have an expected life expectancy of at least 5 months.
boolean
C0023671 (UMLS CUI [1])
ECOG performance status; serum creatinine; creatinine clearance
Item
Have an Eastern Cooperative Oncology Group (ECOG) performance scale status of 0 - 2l) Must have a serum creatinine <2.0 and creatinine clearance >30 ml/min/m2. Other organ dysfunction is eligible at the discretion of the PI.
boolean
C1520224 (UMLS CUI [1])
C0600061 (UMLS CUI [2])
C0812399 (UMLS CUI [3])
birth control
Item
Agree to use a reliable method of birth control prior to drug initiation and for the duration of their study participation.
boolean
C0700589 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
chemotherapy; radiotherapy
Item
a) Have received chemotherapy or radiotherapy within 4 weeks
boolean
C3665472 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
Adverse effects; therapy
Item
Have not recovered from the adverse effects or toxicities of lymphoma therapy most recently administered.
boolean
C0879626 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Investigational New Drugs
Item
Currently receiving any other investigational medication or therapy.
boolean
C0013230 (UMLS CUI [1])
second malignancy
Item
Patients with a second malignancy that might interfere with interpretation of the results of this study.
boolean
C0085183 (UMLS CUI [1])
allergic reaction; Tenofovir disoproxil fumarate
Item
Patients with known allergic reaction to lamivudine or tenofovir disoproxil fumarate (DF).
boolean
C1527304 (UMLS CUI [1])
C1099776 (UMLS CUI [2])
Drug interference; renal function
Item
Patients on drugs that interfere with renal function or drugs that compete with tenofovir for active binding sites (i.e. intravenous cidofovir, acyclovir, ganciclovir, and valganciclovir).
boolean
C1547774 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
concurrent; Disease
Item
Uncontrolled concurrent illnesses, including, but not limited to, active/ongoing infection, symptomatic congestive heart failure, unstable angina pectoris.
boolean
C0205420 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
pregnant; Breast Feeding
Item
Women who are pregnant, become pregnant, or are breast-feeding.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV positive
Item
Standard blood tests that are positive for HIV infection
boolean
C0745002 (UMLS CUI [1])
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