ID

18027

Descripción

Tositumomab And Iodine I 131-Tositumomab In Patients With Relapsed Indolent Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00240565

Link

https://clinicaltrials.gov/show/NCT00240565

Palabras clave

Versiones (1)
  1. 15/10/16 15/10/16 -
Subido en

15 de octubre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT00240565

Inglés

Eligibility Lymphoma, Non-Hodgkin NCT00240565

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have evidence of persistent or progressive follicular grade, 1, 2 or 3 or marginal zone b-cell non-hodgkin's lymphoma.
Descripción

Lymphoma, Follicular persistent Evidence | Lymphoma, Follicular Progressive Evidence | Ann Arbor lymphoma staging system | Marginal Zone B-Cell Lymphoma Evidence

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C0205322
UMLS CUI [1,3]
C3887511
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C0205329
UMLS CUI [2,3]
C3887511
UMLS CUI [3]
C0432516
UMLS CUI [4,1]
C1367654
UMLS CUI [4,2]
C3887511
must have received at least two prior courses of systemic treatment including at least one treatment of rituximab (lymphoma must not have progressed during their most recent systemic chemotherapy treatment).
Descripción

systemic therapy Course Quantity Lymphoma | rituximab | Disease Progression | Systemic Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0024299
UMLS CUI [2]
C0393022
UMLS CUI [3]
C0242656
UMLS CUI [4]
C1883256
must have evidence that their lymphoma expresses cd20 antigen and have adequate renal and hepatic function.
Descripción

Lymphoma CD20 Antigen Expression Evidence | Renal function | Liver function

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0054946
UMLS CUI [1,3]
C0017262
UMLS CUI [1,4]
C3887511
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
received chemotherapy, radiation therapy, immunosuppressants or cytokine treatment within 4 weeks prior to study entry.
Descripción

Chemotherapy | Therapeutic radiology procedure | Immunosuppressive Agents | Cytokine therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0199974
have active obstructive hydronephrosis.
Descripción

Hydronephrosis Obstructive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020295
UMLS CUI [1,2]
C0549186
had prior autologous hematopoietic stem cell transplant or any allogenic stem cell transplant.
Descripción

Transplantation of autologous hematopoietic stem cell | Allogeneic Stem Cell Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1831743
UMLS CUI [2]
C2242529
have active infection requiring iv antibiotics.
Descripción

Communicable Disease Requirement Intravenous antibiotic therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0559680
have brain or leptomeningeal metastasis.
Descripción

Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
had previous allergic reaction to iodine, previously received radioimmunotherapy or are currently receiving approved or experimental anti-cancer drugs.
Descripción

Allergic Reaction Iodine | Radioimmunotherapy | Antineoplastic Agents Approved | Antineoplastic Agents Investigational

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0021968
UMLS CUI [2]
C0085101
UMLS CUI [3,1]
C0003392
UMLS CUI [3,2]
C0205540
UMLS CUI [4,1]
C0003392
UMLS CUI [4,2]
C1517586
patients who are pregnant or breast feeding, have known hiv infection, or are human anti-murine antibody (hama) positive.
Descripción

Pregnancy | Breast Feeding | HIV Infections | Human anti-mouse antibody Positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0019693
UMLS CUI [4,1]
C1291910
UMLS CUI [4,2]
C1514241
other criteria will be evaluated at the screening visit.
Descripción

criteria Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Lymphoma, Non-Hodgkin NCT00240565

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, Follicular persistent Evidence | Lymphoma, Follicular Progressive Evidence | Ann Arbor lymphoma staging system | Marginal Zone B-Cell Lymphoma Evidence
Item
patients must have evidence of persistent or progressive follicular grade, 1, 2 or 3 or marginal zone b-cell non-hodgkin's lymphoma.
boolean
C0024301 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C3887511 (UMLS CUI [1,3])
C0024301 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C3887511 (UMLS CUI [2,3])
C0432516 (UMLS CUI [3])
C1367654 (UMLS CUI [4,1])
C3887511 (UMLS CUI [4,2])
systemic therapy Course Quantity Lymphoma | rituximab | Disease Progression | Systemic Chemotherapy
Item
must have received at least two prior courses of systemic treatment including at least one treatment of rituximab (lymphoma must not have progressed during their most recent systemic chemotherapy treatment).
boolean
C1515119 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0024299 (UMLS CUI [1,4])
C0393022 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C1883256 (UMLS CUI [4])
Lymphoma CD20 Antigen Expression Evidence | Renal function | Liver function
Item
must have evidence that their lymphoma expresses cd20 antigen and have adequate renal and hepatic function.
boolean
C0024299 (UMLS CUI [1,1])
C0054946 (UMLS CUI [1,2])
C0017262 (UMLS CUI [1,3])
C3887511 (UMLS CUI [1,4])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Immunosuppressive Agents | Cytokine therapy
Item
received chemotherapy, radiation therapy, immunosuppressants or cytokine treatment within 4 weeks prior to study entry.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0199974 (UMLS CUI [4])
Hydronephrosis Obstructive
Item
have active obstructive hydronephrosis.
boolean
C0020295 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
Transplantation of autologous hematopoietic stem cell | Allogeneic Stem Cell Transplantation
Item
had prior autologous hematopoietic stem cell transplant or any allogenic stem cell transplant.
boolean
C1831743 (UMLS CUI [1])
C2242529 (UMLS CUI [2])
Communicable Disease Requirement Intravenous antibiotic therapy
Item
have active infection requiring iv antibiotics.
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0559680 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain | Metastatic Malignant Neoplasm to the Leptomeninges
Item
have brain or leptomeningeal metastasis.
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
Allergic Reaction Iodine | Radioimmunotherapy | Antineoplastic Agents Approved | Antineoplastic Agents Investigational
Item
had previous allergic reaction to iodine, previously received radioimmunotherapy or are currently receiving approved or experimental anti-cancer drugs.
boolean
C1527304 (UMLS CUI [1,1])
C0021968 (UMLS CUI [1,2])
C0085101 (UMLS CUI [2])
C0003392 (UMLS CUI [3,1])
C0205540 (UMLS CUI [3,2])
C0003392 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | HIV Infections | Human anti-mouse antibody Positive
Item
patients who are pregnant or breast feeding, have known hiv infection, or are human anti-murine antibody (hama) positive.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C1291910 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
criteria Other
Item
other criteria will be evaluated at the screening visit.
boolean
C0243161 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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