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
Versions (2)
- 12/9/13 12/9/13 - Martin Dugas
- 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
- StudyEvent: Eligibility
Description
Patient characteristics and prior concurrent therapy
Description
Age
Data type
boolean
Description
Performance Status
Data type
boolean
Description
Hematopoietic
Data type
boolean
Description
Hepatic
Data type
boolean
Description
Renal
Data type
boolean
Description
Cardiovascular
Data type
boolean
Description
Pulmonary
Data type
boolean
Description
Other
Data type
boolean
Description
Prior concurrent therapy
Data type
boolean
Description
Medical Concepts
Description
Diagnosis
Data type
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Description
Diagnostic Neoplasm Staging
Data type
string
Alias
- UMLS CUI
- C0027646
Description
Bone Marrow Involvement
Data type
string
Alias
- UMLS CUI
- C1517677
Description
Age
Data type
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Description
ECOG performance status
Data type
string
Alias
- SNOMED CT 2010_0731
- 423740007
Description
Karnofsky performance status
Data type
string
Alias
- SNOMED CT 2010_0731
- 273546003
Description
WBC
Data type
string
Alias
- SNOMED CT 2010_0731
- 767002
- LOINC
- 6690-2
Description
Platelet count - finding (Code )
Data type
string
Alias
- SNOMED CT 2010_0731
- 365632008
- UMLS CUI
- C1287267
- LOINC
- 777-3
Description
Bilirubin
Data type
string
Alias
- SNOMED CT 2010_0731
- 79706000
- UMLS CUI
- C0011221
- LOINC
- 1975-2
Description
Hepatitis
Data type
string
Alias
- SNOMED CT 2010_0731
- 29001004
- UMLS CUI
- C0019158
Description
Creatinine
Data type
string
Alias
- UMLS CUI
- C0010294
- SNOMED CT 2010_0731
- 15373003
- LOINC
- 38483-4
- MedDRA 13.1
- 10011358
Description
Canadian Cardiovascular Society classification of angina (Code )
Data type
string
Alias
- UMLS CUI
- C1277207
- SNOMED CT 2010_0731
- 134438001
Description
New York Heart Association Classification
Data type
string
Alias
- UMLS CUI
- C1275491
- SNOMED CT 2010_0731
- 420816009
Description
Cardiac ejection fraction
Data type
string
Alias
- UMLS CUI
- C0232174
- SNOMED CT 2010_0731
- 70822001
Description
Forced expired volume in one second/vital capacity ratio
Data type
string
Alias
- UMLS CUI
- C0429744
- SNOMED CT 2010_0731
- 251943006
Description
Diffusion capacity of lung
Data type
string
Alias
- UMLS CUI
- C0231971
- SNOMED CT 2010_0731
- 54715006
Description
Diabetes mellitus
Data type
string
Alias
- UMLS CUI
- C0011849
- SNOMED CT 2010_0731
- 191044006
Description
Allergic reaction, due to correct medicinal substance properly administered
Data type
string
Alias
- UMLS CUI
- C0274302
- SNOMED CT 2010_0731
- 57302007
Description
HIV negative
Data type
string
Alias
- UMLS CUI
- C0481430
- SNOMED CT 2010_0731
- 143223008
Description
Chemotherapy
Data type
string
Alias
- UMLS CUI
- C0392920
- SNOMED CT 2010_0731
- 150415003
Description
Radiotherapy
Data type
string
Alias
- UMLS CUI
- C1522449
- SNOMED CT 2010_0731
- 302505005
Description
Enrollment
Data type
string
Alias
- UMLS CUI
- C1516879
Description
Therapeutic procedure
Data type
string
Alias
- UMLS CUI
- C0087111
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Eligibility
- StudyEvent: Eligibility
439401001 (SNOMED CT 2010_0731)
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C0019158 (UMLS CUI)
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251943006 (SNOMED CT 2010_0731)
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