ID

13627

Description

Pivotal Study of Iodine I 131 Tositumomab for Chemotherapy-refractory Low-grade or Transformed Low-grade B-cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00989664

Link

https://clinicaltrials.gov/show/NCT00989664

Keywords

Versions (1)
  1. 2/21/16 2/21/16 -
Uploaded on

February 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma, Non-Hodgkin NCT00989664

English

Eligibility Lymphoma, Non-Hodgkin NCT00989664

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female subjects ≥18 years of age with histologically confirmed at initial diagnosis, previously treated (at least 2 prior chemotherapy regimens), low-grade nhl or low-grade lymphoma that had transformed to intermediate- or high-grade histology.
Description

Gender, Age, prior chemotherapy, low-grade lymphoma (NHL) transformed

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1514457
UMLS CUI [4]
C0278885
UMLS CUI [5]
C0079747
UMLS CUI [6]
C1536010
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with more than an average of 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 42 days of study entry. bilateral posterior iliac crest core biopsies are required if the percentage of intratrebecular space involved exceeds 10% in a unilateral biopsy. the mean of bilateral biopsies must be no more than 25%.
Description

lymphoma involvment of bone marrow, iliac crest biopsy

Data type

boolean

Alias
UMLS CUI [1]
C1301440
UMLS CUI [2]
C0229621
UMLS CUI [3]
C0005954
cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
Description

chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0199974
prior stem cell transplant.
Description

stem cell transplant

Data type

boolean

Alias
UMLS CUI [1]
C1504389
active obstructive hydronephrosis.
Description

obstructive hydronephrosis

Data type

boolean

Alias
UMLS CUI [1]
C0020295
evidence of active infection requiring intravenous (iv) antibiotics at the time of study entry.
Description

active infection with iv antibiotics

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0559680
new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
Description

new york heart association or other comorbidity precluding evaluation

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0009488
prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.
Description

malignancies

Data type

boolean

Alias
UMLS CUI [1]
C0006826
known hiv infection.
Description

hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019682
known brain or leptomeningeal metastases.
Description

brain metastases, leptomeningeal metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C1704231
subjects who are pregnant or nursing.
Description

pregnant or nursing

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
previous allergic reactions to iodine. this does not include reactions to intravenous iodine-containing contrast materials.
Description

allergic reactions to iodine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021968
prior exposure to monoclonal or polyclonal antibodies of any non-human species for either diagnostic or therapeutic purposes, including engineered chimeric and humanized antibodies.
Description

Antibodies

Data type

boolean

Alias
UMLS CUI [1]
C0003241
prior radioimmunotherapy.
Description

prior radioimmunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0085101
progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.
Description

progressive disease after radiation, radation dosage

Data type

boolean

Alias
UMLS CUI [1]
C0677932
UMLS CUI [2]
C0521982
UMLS CUI [3]
C0034524
current use of either approved or non-approved (through another protocol) anti-cancer drugs or biologics
Description

cancer therapy

Data type

boolean

Alias
UMLS CUI [1]
C0920425
de novo intermediate- or high-grade lymphoma.
Description

de novo intermediate- or high-grade lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0079741
UMLS CUI [2]
C0079740
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Similar models

Eligibility Lymphoma, Non-Hodgkin NCT00989664

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender, Age, prior chemotherapy, low-grade lymphoma (NHL) transformed
Item
male and female subjects ≥18 years of age with histologically confirmed at initial diagnosis, previously treated (at least 2 prior chemotherapy regimens), low-grade nhl or low-grade lymphoma that had transformed to intermediate- or high-grade histology.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1514457 (UMLS CUI [3])
C0278885 (UMLS CUI [4])
C0079747 (UMLS CUI [5])
C1536010 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
lymphoma involvment of bone marrow, iliac crest biopsy
Item
subjects with more than an average of 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 42 days of study entry. bilateral posterior iliac crest core biopsies are required if the percentage of intratrebecular space involved exceeds 10% in a unilateral biopsy. the mean of bilateral biopsies must be no more than 25%.
boolean
C1301440 (UMLS CUI [1])
C0229621 (UMLS CUI [2])
C0005954 (UMLS CUI [3])
chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment
Item
cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0199974 (UMLS CUI [4])
stem cell transplant
Item
prior stem cell transplant.
boolean
C1504389 (UMLS CUI [1])
obstructive hydronephrosis
Item
active obstructive hydronephrosis.
boolean
C0020295 (UMLS CUI [1])
active infection with iv antibiotics
Item
evidence of active infection requiring intravenous (iv) antibiotics at the time of study entry.
boolean
C0009450 (UMLS CUI [1])
C0559680 (UMLS CUI [2])
new york heart association or other comorbidity precluding evaluation
Item
new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
boolean
C1275491 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
malignancies
Item
prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.
boolean
C0006826 (UMLS CUI [1])
hiv
Item
known hiv infection.
boolean
C0019682 (UMLS CUI [1])
brain metastases, leptomeningeal metastases
Item
known brain or leptomeningeal metastases.
boolean
C0220650 (UMLS CUI [1])
C1704231 (UMLS CUI [2])
pregnant or nursing
Item
subjects who are pregnant or nursing.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
allergic reactions to iodine
Item
previous allergic reactions to iodine. this does not include reactions to intravenous iodine-containing contrast materials.
boolean
C0020517 (UMLS CUI [1,1])
C0021968 (UMLS CUI [1,2])
Antibodies
Item
prior exposure to monoclonal or polyclonal antibodies of any non-human species for either diagnostic or therapeutic purposes, including engineered chimeric and humanized antibodies.
boolean
C0003241 (UMLS CUI [1])
prior radioimmunotherapy
Item
prior radioimmunotherapy.
boolean
C0085101 (UMLS CUI [1])
progressive disease after radiation, radation dosage
Item
progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.
boolean
C0677932 (UMLS CUI [1])
C0521982 (UMLS CUI [2])
C0034524 (UMLS CUI [3])
cancer therapy
Item
current use of either approved or non-approved (through another protocol) anti-cancer drugs or biologics
boolean
C0920425 (UMLS CUI [1])
de novo intermediate- or high-grade lymphoma
Item
de novo intermediate- or high-grade lymphoma.
boolean
C0079741 (UMLS CUI [1])
C0079740 (UMLS CUI [2])
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