ID

4465

Description

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

Keywords

  1. 12/9/13 12/9/13 - Martin Dugas
  2. 12/22/14 12/22/14 - Martin Dugas
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00052936 NHL

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Disease characteristics
Description

Disease characteristics

Aggressive non-Hodgkin's lymphoma (NHL)
Description

Aggressive non-Hodgkin's lymphoma (NHL)

Data type

boolean

B-cell NHL
Description

B-cell NHL

Data type

boolean

T-cell NHL
Description

T-cell NHL

Data type

boolean

Bone marrow
Description

Bone marrow

Data type

boolean

CNS / GI
Description

CNS / GI

Data type

boolean

Patient characteristics and prior concurrent therapy
Description

Patient characteristics and prior concurrent therapy

Age
Description

Age

Data type

boolean

Performance Status
Description

Performance Status

Data type

boolean

Hematopoietic
Description

Hematopoietic

Data type

boolean

Hepatic
Description

Hepatic

Data type

boolean

Renal
Description

Renal

Data type

boolean

Cardiovascular
Description

Cardiovascular

Data type

boolean

Pulmonary
Description

Pulmonary

Data type

boolean

Other
Description

Other

Data type

boolean

Prior concurrent therapy
Description

Prior concurrent therapy

Data type

boolean

Medizinische Konzepte
Description

Medizinische Konzepte

Diagnosis
Description

Diagnosis

Data type

string

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

Diagnostic Neoplasm Staging

Data type

string

Alias
UMLS CUI
C0027646
Bone Marrow Involvement
Description

Bone Marrow Involvement

Data type

string

Alias
UMLS CUI
C1517677
Age
Description

Age

Data type

string

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

ECOG performance status

Data type

string

Alias
SNOMED CT 2010_0731
423740007
Karnofsky performance status
Description

Karnofsky performance status

Data type

string

Alias
SNOMED CT 2010_0731
273546003
WBC
Description

WBC

Data type

string

Alias
SNOMED CT 2010_0731
767002
LOINC
6690-2
Platelet count - finding (Code )
Description

Platelet count - finding (Code )

Data type

string

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

Bilirubin

Data type

string

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

Hepatitis

Data type

string

Alias
SNOMED CT 2010_0731
29001004
UMLS CUI
C0019158
Creatinine
Description

Creatinine

Data type

string

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

Canadian Cardiovascular Society classification of angina (Code )

Data type

string

Alias
UMLS CUI
C1277207
SNOMED CT 2010_0731
134438001
New York Heart Association Classification
Description

New York Heart Association Classification

Data type

string

Alias
UMLS CUI
C1275491
SNOMED CT 2010_0731
420816009
Cardiac ejection fraction
Description

Cardiac ejection fraction

Data type

string

Alias
UMLS CUI
C0232174
SNOMED CT 2010_0731
70822001
Forced expired volume in one second/vital capacity ratio
Description

Forced expired volume in one second/vital capacity ratio

Data type

string

Alias
UMLS CUI
C0429744
SNOMED CT 2010_0731
251943006
Diffusion capacity of lung
Description

Diffusion capacity of lung

Data type

string

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

Diabetes mellitus

Data type

string

Alias
UMLS CUI
C0011849
SNOMED CT 2010_0731
191044006
Allergic reaction, due to correct medicinal substance properly administered
Description

Allergic reaction, due to correct medicinal substance properly administered

Data type

string

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

HIV negative

Data type

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
Chemotherapy
Description

Chemotherapy

Data type

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Radiotherapy
Description

Radiotherapy

Data type

string

Alias
UMLS CUI
C1522449
SNOMED CT 2010_0731
302505005
Enrollment
Description

Enrollment

Data type

string

Alias
UMLS CUI
C1516879
Therapeutic procedure
Description

Therapeutic procedure

Data type

string

Alias
UMLS CUI
C0087111

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Aggressive non-Hodgkin's lymphoma (NHL)
Item
boolean
B-cell NHL
Item
boolean
T-cell NHL
Item
boolean
Bone marrow
Item
boolean
CNS / GI
Item
boolean
Age
Item
boolean
Performance Status
Item
boolean
Hematopoietic
Item
boolean
Hepatic
Item
boolean
Renal
Item
boolean
Cardiovascular
Item
boolean
Pulmonary
Item
boolean
Other
Item
boolean
Prior concurrent therapy
Item
boolean
Item Group
Medizinische Konzepte
Diagnosis
Item
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
Diagnostic Neoplasm Staging
Item
string
C0027646 (UMLS CUI)
Bone Marrow Involvement
Item
string
C1517677 (UMLS CUI)
Age
Item
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
ECOG performance status
Item
string
423740007 (SNOMED CT 2010_0731)
Karnofsky performance status
Item
string
273546003 (SNOMED CT 2010_0731)
WBC
Item
string
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC)
Platelet count - finding (Code )
Item
string
365632008 (SNOMED CT 2010_0731)
C1287267 (UMLS CUI)
777-3 (LOINC)
Bilirubin
Item
string
79706000 (SNOMED CT 2010_0731)
C0011221 (UMLS CUI)
1975-2 (LOINC)
Hepatitis
Item
string
29001004 (SNOMED CT 2010_0731)
C0019158 (UMLS CUI)
Creatinine
Item
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Canadian Cardiovascular Society classification of angina (Code )
Item
string
C1277207 (UMLS CUI)
134438001 (SNOMED CT 2010_0731)
New York Heart Association Classification
Item
string
C1275491 (UMLS CUI)
420816009 (SNOMED CT 2010_0731)
Cardiac ejection fraction
Item
string
C0232174 (UMLS CUI)
70822001 (SNOMED CT 2010_0731)
Forced expired volume in one second/vital capacity ratio
Item
string
C0429744 (UMLS CUI)
251943006 (SNOMED CT 2010_0731)
Diffusion capacity of lung
Item
string
C0231971 (UMLS CUI)
54715006 (SNOMED CT 2010_0731)
Diabetes mellitus
Item
string
C0011849 (UMLS CUI)
191044006 (SNOMED CT 2010_0731)
Allergic reaction, due to correct medicinal substance properly administered
Item
string
C0274302 (UMLS CUI)
57302007 (SNOMED CT 2010_0731)
HIV negative
Item
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
Chemotherapy
Item
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
Radiotherapy
Item
string
C1522449 (UMLS CUI)
302505005 (SNOMED CT 2010_0731)
Enrollment
Item
string
C1516879 (UMLS CUI)
Therapeutic procedure
Item
string
C0087111 (UMLS CUI)

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