ID

4465

Beschreibung

Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma DISEASE CHARACTERISTICS: - Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) by an excisional biopsy of a lymph node or an extensive biopsy of an extranodal involvement (if there is no lymph node involvement) - CD20^+ B-cell lymphoma or CD20^- B-cell and T-cell lymphoma allowed - B-cell NHL including the following: Stage III follicular lymphoma; Stage III follicular lymphoma and diffuse B-cell lymphoma; Lymphoblastic precursor B-cell lymphoma; Diffuse large cell B-cell lymphoma; Centroblastic; Immunoblastic; Plasmablastic; Anaplastic large cell; T-cell-rich B-cell lymphoma; Primary effusion lymphoma; Intravasal B-cell lymphoma; Primary mediastinal B-cell lymphoma; Mantle zone lymphoma, blastoid; Burkitt's lymphoma; Burkitt-like lymphoma; Aggressive marginal zone lymphoma (monocytoid); - T-cell NHL including the following: Lymphoblastic precursor T-cell lymphoma; Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS); Lennert's lymphoma; T-zone lymphoma; T-cell lymphoma of the angioimmunoblastic lymphadenopathy with dysproteinemia (AILD) type; Anaplastic large cell lymphoma; ALK^+ - ALK^-; Extranodal NK/T-cell lymphoma, nasal type; Intestinal T/NK-cell lymphoma (with or without enteropathy); Hepatosplenic gamma-delta lymphoma; Subcutaneous panniculitis-like PTCL; Aggressive T/NK PTCL; Anaplastic large-cell NHL, NOS - Bone marrow involvement no more than 25% - No lymphoma that is clearly restricted to the CNS or originating from the gastrointestinal tract PATIENT CHARACTERISTICS: Age - 61 to 80 Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - WBC at least 2,500/mm^3; Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN); No active hepatitis infection Renal - Creatinine no greater than 2 times ULN Cardiovascular - No Canadian Cardiovascular Society class III or IV angina pectoris - No New York Heart Association class III or IV cardiac failure - Ejection fraction at least 50% - Fractional shortenings at least 25% by echocardiography or nuclear medicine examination Pulmonary - FEV1 at least 50% - Diffusion capacity at least 50% Other - No uncontrolled diabetes mellitus - No known hypersensitivity to any study medications - No other concurrent malignancy - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy Surgery - Not specified Other - Must not have already initiated lymphoma therapy (except for the prephase treatment specified for this study) - No other concurrent lymphoma therapy - No concurrent participation in another treatment study

Stichworte

Versionen (2)
  1. 09.12.13 09.12.13 - Martin Dugas
  2. 22.12.14 22.12.14 - Martin Dugas
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9. Dezember 2013

DOI

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Eligibility NCT00052936 NHL

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Disease characteristics
Beschreibung

Disease characteristics

Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) by an excisional biopsy of a lymph node or an extensive biopsy of an extranodal involvement (if there is no lymph node involvement); CD20^+ B-cell lymphoma or CD20^- B-cell and T-cell lymphoma allowed
Beschreibung

Aggressive non-Hodgkin's lymphoma (NHL)

Datentyp

boolean

B-cell NHL including the following: Stage III follicular lymphoma; Stage III follicular lymphoma and diffuse B-cell lymphoma; Lymphoblastic precursor B-cell lymphoma; Diffuse large cell B-cell lymphoma; Centroblastic; Immunoblastic; Plasmablastic; Anaplastic large cell; T-cell-rich B-cell lymphoma; Primary effusion lymphoma; Intravasal B-cell lymphoma; Primary mediastinal B-cell lymphoma; Mantle zone lymphoma, blastoid; Burkitt's lymphoma; Burkitt-like lymphoma; Aggressive marginal zone lymphoma (monocytoid)
Beschreibung

B-cell NHL

Datentyp

boolean

T-cell NHL including the following: Lymphoblastic precursor T-cell lymphoma; Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS); Lennert's lymphoma; T-zone lymphoma; T-cell lymphoma of the angioimmunoblastic lymphadenopathy with dysproteinemia (AILD) type; Anaplastic large cell lymphoma; ALK^+ - ALK^-; Extranodal NK/T-cell lymphoma, nasal type; Intestinal T/NK-cell lymphoma (with or without enteropathy); Hepatosplenic gamma-delta lymphoma; Subcutaneous panniculitis-like PTCL; Aggressive T/NK PTCL; Anaplastic large-cell NHL, NOS
Beschreibung

T-cell NHL

Datentyp

boolean

Bone marrow involvement no more than 25%
Beschreibung

Bone marrow

Datentyp

boolean

No lymphoma that is clearly restricted to the CNS or originating from the gastrointestinal tract
Beschreibung

CNS / GI

Datentyp

boolean

Patient characteristics and prior concurrent therapy
Beschreibung

Patient characteristics and prior concurrent therapy

Age 61 to 80
Beschreibung

Age

Datentyp

boolean

ECOG 0-2 OR - Karnofsky 60-100%
Beschreibung

Performance Status

Datentyp

boolean

WBC at least 2,500/mm^3; Platelet count at least 100,000/mm^3
Beschreibung

Hematopoietic

Datentyp

boolean

Bilirubin no greater than 2 times upper limit of normal (ULN); No active hepatitis infection
Beschreibung

Hepatic

Datentyp

boolean

Creatinine no greater than 2 times ULN
Beschreibung

Renal

Datentyp

boolean

No Canadian Cardiovascular Society class III or IV angina pectoris; No New York Heart Association class III or IV cardiac failure; Ejection fraction at least 50%; Fractional shortenings at least 25% by echocardiography or nuclear medicine examination
Beschreibung

Cardiovascular

Datentyp

boolean

FEV1 at least 50%; Diffusion capacity at least 50%
Beschreibung

Pulmonary

Datentyp

boolean

No uncontrolled diabetes mellitus; No known hypersensitivity to any study medications; No other concurrent malignancy; HIV negative
Beschreibung

Other

Datentyp

boolean

No prior chemotherapy; No prior radiotherapy; Must not have already initiated lymphoma therapy (except for the prephase treatment specified for this study); No other concurrent lymphoma therapy; No concurrent participation in another treatment study
Beschreibung

Prior concurrent therapy

Datentyp

boolean

Medical Concepts
Beschreibung

Medical Concepts

Diagnosis
Beschreibung

Diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Diagnostic Neoplasm Staging
Beschreibung

Diagnostic Neoplasm Staging

Datentyp

string

Alias
UMLS CUI
C0027646
Bone Marrow Involvement
Beschreibung

Bone Marrow Involvement

Datentyp

string

Alias
UMLS CUI
C1517677
Age
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
ECOG performance status
Beschreibung

ECOG performance status

Datentyp

string

Alias
SNOMED CT 2010_0731
423740007
Karnofsky performance status
Beschreibung

Karnofsky performance status

Datentyp

string

Alias
SNOMED CT 2010_0731
273546003
White blood cell count
Beschreibung

WBC

Datentyp

string

Alias
SNOMED CT 2010_0731
767002
LOINC
6690-2
Platelet count - finding
Beschreibung

Platelet count - finding (Code )

Datentyp

string

Alias
SNOMED CT 2010_0731
365632008
UMLS CUI
C1287267
LOINC
777-3
Bilirubin
Beschreibung

Bilirubin

Datentyp

string

Alias
SNOMED CT 2010_0731
79706000
UMLS CUI
C0011221
LOINC
1975-2
Hepatitis
Beschreibung

Hepatitis

Datentyp

string

Alias
SNOMED CT 2010_0731
29001004
UMLS CUI
C0019158
Creatinine
Beschreibung

Creatinine

Datentyp

string

Alias
UMLS CUI
C0010294
SNOMED CT 2010_0731
15373003
LOINC
38483-4
MedDRA 13.1
10011358
Canadian Cardiovascular Society classification of angina
Beschreibung

Canadian Cardiovascular Society classification of angina (Code )

Datentyp

string

Alias
UMLS CUI
C1277207
SNOMED CT 2010_0731
134438001
NYHA class
Beschreibung

New York Heart Association Classification

Datentyp

string

Alias
UMLS CUI
C1275491
SNOMED CT 2010_0731
420816009
Ejection fraction
Beschreibung

Cardiac ejection fraction

Datentyp

string

Alias
UMLS CUI
C0232174
SNOMED CT 2010_0731
70822001
FEV1/VC ratio
Beschreibung

Forced expired volume in one second/vital capacity ratio

Datentyp

string

Alias
UMLS CUI
C0429744
SNOMED CT 2010_0731
251943006
Diffusion capacity
Beschreibung

Diffusion capacity of lung

Datentyp

string

Alias
UMLS CUI
C0231971
SNOMED CT 2010_0731
54715006
Diabetes mellitus
Beschreibung

Diabetes mellitus

Datentyp

string

Alias
UMLS CUI
C0011849
SNOMED CT 2010_0731
191044006
Hypersensitivity to medication
Beschreibung

Allergic reaction, due to correct medicinal substance properly administered

Datentyp

string

Alias
UMLS CUI
C0274302
SNOMED CT 2010_0731
57302007
HIV negative
Beschreibung

HIV negative

Datentyp

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
Chemotherapy
Beschreibung

Chemotherapy

Datentyp

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Radiotherapy
Beschreibung

Radiotherapy

Datentyp

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
Enrollment
Beschreibung

Enrollment

Datentyp

string

Alias
UMLS CUI
C1516879
Therapeutic procedure
Beschreibung

Therapeutic procedure

Datentyp

string

Alias
UMLS CUI
C0087111
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Disease characteristics
Aggressive non-Hodgkin's lymphoma (NHL)
Item
Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) by an excisional biopsy of a lymph node or an extensive biopsy of an extranodal involvement (if there is no lymph node involvement); CD20^+ B-cell lymphoma or CD20^- B-cell and T-cell lymphoma allowed
boolean
B-cell NHL
Item
B-cell NHL including the following: Stage III follicular lymphoma; Stage III follicular lymphoma and diffuse B-cell lymphoma; Lymphoblastic precursor B-cell lymphoma; Diffuse large cell B-cell lymphoma; Centroblastic; Immunoblastic; Plasmablastic; Anaplastic large cell; T-cell-rich B-cell lymphoma; Primary effusion lymphoma; Intravasal B-cell lymphoma; Primary mediastinal B-cell lymphoma; Mantle zone lymphoma, blastoid; Burkitt's lymphoma; Burkitt-like lymphoma; Aggressive marginal zone lymphoma (monocytoid)
boolean
T-cell NHL
Item
T-cell NHL including the following: Lymphoblastic precursor T-cell lymphoma; Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS); Lennert's lymphoma; T-zone lymphoma; T-cell lymphoma of the angioimmunoblastic lymphadenopathy with dysproteinemia (AILD) type; Anaplastic large cell lymphoma; ALK^+ - ALK^-; Extranodal NK/T-cell lymphoma, nasal type; Intestinal T/NK-cell lymphoma (with or without enteropathy); Hepatosplenic gamma-delta lymphoma; Subcutaneous panniculitis-like PTCL; Aggressive T/NK PTCL; Anaplastic large-cell NHL, NOS
boolean
Bone marrow
Item
Bone marrow involvement no more than 25%
boolean
CNS / GI
Item
No lymphoma that is clearly restricted to the CNS or originating from the gastrointestinal tract
boolean
Item Group
Patient characteristics and prior concurrent therapy
Age
Item
Age 61 to 80
boolean
Performance Status
Item
ECOG 0-2 OR - Karnofsky 60-100%
boolean
Hematopoietic
Item
WBC at least 2,500/mm^3; Platelet count at least 100,000/mm^3
boolean
Hepatic
Item
Bilirubin no greater than 2 times upper limit of normal (ULN); No active hepatitis infection
boolean
Renal
Item
Creatinine no greater than 2 times ULN
boolean
Cardiovascular
Item
No Canadian Cardiovascular Society class III or IV angina pectoris; No New York Heart Association class III or IV cardiac failure; Ejection fraction at least 50%; Fractional shortenings at least 25% by echocardiography or nuclear medicine examination
boolean
Pulmonary
Item
FEV1 at least 50%; Diffusion capacity at least 50%
boolean
Other
Item
No uncontrolled diabetes mellitus; No known hypersensitivity to any study medications; No other concurrent malignancy; HIV negative
boolean
Prior concurrent therapy
Item
No prior chemotherapy; No prior radiotherapy; Must not have already initiated lymphoma therapy (except for the prephase treatment specified for this study); No other concurrent lymphoma therapy; No concurrent participation in another treatment study
boolean
Item Group
Medical Concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
Diagnostic Neoplasm Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
Bone Marrow Involvement
Item
Bone Marrow Involvement
string
C1517677 (UMLS CUI)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
ECOG performance status
Item
ECOG performance status
string
423740007 (SNOMED CT 2010_0731)
Karnofsky performance status
Item
Karnofsky performance status
string
273546003 (SNOMED CT 2010_0731)
WBC
Item
White blood cell count
string
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC)
Platelet count - finding (Code )
Item
Platelet count - finding
string
365632008 (SNOMED CT 2010_0731)
C1287267 (UMLS CUI)
777-3 (LOINC)
Bilirubin
Item
Bilirubin
string
79706000 (SNOMED CT 2010_0731)
C0011221 (UMLS CUI)
1975-2 (LOINC)
Hepatitis
Item
Hepatitis
string
29001004 (SNOMED CT 2010_0731)
C0019158 (UMLS CUI)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Canadian Cardiovascular Society classification of angina (Code )
Item
Canadian Cardiovascular Society classification of angina
string
C1277207 (UMLS CUI)
134438001 (SNOMED CT 2010_0731)
New York Heart Association Classification
Item
NYHA class
string
C1275491 (UMLS CUI)
420816009 (SNOMED CT 2010_0731)
Cardiac ejection fraction
Item
Ejection fraction
string
C0232174 (UMLS CUI)
70822001 (SNOMED CT 2010_0731)
Forced expired volume in one second/vital capacity ratio
Item
FEV1/VC ratio
string
C0429744 (UMLS CUI)
251943006 (SNOMED CT 2010_0731)
Diffusion capacity of lung
Item
Diffusion capacity
string
C0231971 (UMLS CUI)
54715006 (SNOMED CT 2010_0731)
Diabetes mellitus
Item
Diabetes mellitus
string
C0011849 (UMLS CUI)
191044006 (SNOMED CT 2010_0731)
Allergic reaction, due to correct medicinal substance properly administered
Item
Hypersensitivity to medication
string
C0274302 (UMLS CUI)
57302007 (SNOMED CT 2010_0731)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Radiotherapy
Item
Radiotherapy
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
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