ID

6416

Beschrijving

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

Trefwoorden

  1. 09-12-13 09-12-13 - Martin Dugas
  2. 22-12-14 22-12-14 - Martin Dugas
Geüploaded op

22 december 2014

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00052936 NHL

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Disease characteristics
Beschrijving

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
Beschrijving

Aggressive non-Hodgkin's lymphoma (NHL)

Datatype

boolean

Alias
UMLS CUI-1
C1332225
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)
Beschrijving

B-cell NHL

Datatype

boolean

Alias
UMLS CUI-1
C0079731
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
Beschrijving

T-cell NHL

Datatype

boolean

Alias
UMLS CUI-1
C0079772
Bone marrow involvement no more than 25%
Beschrijving

Bone marrow involvement

Datatype

boolean

Alias
UMLS CUI-1
C1517677
No lymphoma that is clearly restricted to the CNS or originating from the gastrointestinal tract
Beschrijving

CNS or GI lymphoma

Datatype

boolean

Patient characteristics and prior concurrent therapy
Beschrijving

Patient characteristics and prior concurrent therapy

Age 61 to 80
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI-1
C0001779
ECOG 0-2 OR - Karnofsky 60-100%
Beschrijving

Performance Status

Datatype

boolean

Alias
UMLS CUI-1
C1520224
WBC at least 2,500/mm^3
Beschrijving

WBC at least 2,500/mm^3

Datatype

float

Maateenheden
  • mm^3
Alias
UMLS CUI-1
C0023508
mm^3
Platelet count at least 100,000/mm^3
Beschrijving

Platelet count at least 100,000/mm^3

Datatype

float

Maateenheden
  • mm^3
Alias
UMLS CUI-1
C1287267
mm^3
Bilirubin no greater than 2 times upper limit of normal (ULN)
Beschrijving

Bilirubin no greater than 2 times upper limit of normal (ULN)

Datatype

boolean

Alias
UMLS CUI-1
C0201913
No active hepatitis infection
Beschrijving

No active hepatitis infection

Datatype

boolean

Alias
UMLS CUI-1
C0332197
UMLS CUI-2
C0744827
Creatinine no greater than 2 times ULN
Beschrijving

Creatinine

Datatype

boolean

Alias
UMLS CUI-1
C0010294
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
Beschrijving

Absence of heart failure

Datatype

boolean

Alias
UMLS CUI-1
C0332197
UMLS CUI-2
C0018801
FEV1 at least 50%
Beschrijving

FEV1

Datatype

boolean

Alias
UMLS CUI-1
C0849974
Diffusion capacity at least 50%
Beschrijving

Diffusion capacity

Datatype

boolean

Alias
UMLS CUI-1
C0231971
No uncontrolled diabetes mellitus; No known hypersensitivity to any study medications; No other concurrent malignancy; HIV negative
Beschrijving

Other

Datatype

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
Beschrijving

Prior concurrent therapy

Datatype

boolean

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Disease characteristics
Aggressive Non-Hodgkin Lymphoma
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
C1332225 (UMLS CUI-1)
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
C0079731 (UMLS CUI-1)
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
C0079772 (UMLS CUI-1)
Bone marrow involvement
Item
Bone marrow involvement no more than 25%
boolean
C1517677 (UMLS CUI-1)
CNS or GI lymphoma
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
C0001779 (UMLS CUI-1)
Performance Status
Item
ECOG 0-2 OR - Karnofsky 60-100%
boolean
C1520224 (UMLS CUI-1)
WBC
Item
WBC at least 2,500/mm^3
float
C0023508 (UMLS CUI-1)
Platelets
Item
Platelet count at least 100,000/mm^3
float
C1287267 (UMLS CUI-1)
Bilirubin
Item
Bilirubin no greater than 2 times upper limit of normal (ULN)
boolean
C0201913 (UMLS CUI-1)
Absence of active Hepatitis
Item
No active hepatitis infection
boolean
C0332197 (UMLS CUI-1)
C0744827 (UMLS CUI-2)
Creatinine
Item
Creatinine no greater than 2 times ULN
boolean
C0010294 (UMLS CUI-1)
Absence of heart failure
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
C0332197 (UMLS CUI-1)
C0018801 (UMLS CUI-2)
FEV1
Item
FEV1 at least 50%
boolean
C0849974 (UMLS CUI-1)
Diffusion capacity
Item
Diffusion capacity at least 50%
boolean
C0231971 (UMLS CUI-1)
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

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