ID

13966

Description

Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00022880

Link

https://clinicaltrials.gov/show/NCT00022880

Keywords

Versions (1)
  1. 3/20/16 3/20/16 -
Uploaded on

March 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Lymphocytic Leukemia NCT00022880

English

Eligibility Chronic Lymphocytic Leukemia NCT00022880

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must fulfill the criteria for the diagnosis of intermediate-risk b-cell cll or high-risk b-cell cll
Description

Intermediate-risk b-cell cll or high-risk b-cell cll

Data type

boolean

Alias
UMLS CUI [1,1]
C3640764
UMLS CUI [1,2]
C0023434
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0023434
the bone marrow aspirate must demonstrate that greater than or equal to 30% of all nucleated cells are lymphoid.
Description

Nucleated cells on bone marrow aspirate

Data type

boolean

Alias
UMLS CUI [1,1]
C1180059
UMLS CUI [1,2]
C1271729
patients must have evidence that their leukemic lymphocytes express the cd20 antigen.
Description

Leukemic lymphocytes: cd20 antigen positivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0054946
UMLS CUI [1,2]
C1517808
patients must have been previously treated with chemotherapy or biologic therapy and have progressed on, failed to achieve an objective response (cr or partial response [pr]) on, or progressed after completion of last therapy. patients must have received at least one therapy containing a purine nucleoside analogue. patients must not have received more than 4 prior therapies. this includes both chemotherapy and biologic therapy.
Description

Treatment status

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0005527
UMLS CUI [3]
C1704632
UMLS CUI [4]
C1268902
UMLS CUI [5]
C2348184
patients must have an absolute granulocyte count >500 cells/mm3 and a platelet count of either >100,000 cells/mm3 (cohort a) or a platelet count of 75,000-100,000 cells/mm3 deemed to be secondary to cll by the investigator, (cohort b) within 14 days of study entry. these blood counts must be sustained for 4 weeks without support of hematopoietic cytokines or transfusion of blood products.
Description

Blood examination

Data type

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0018928
UMLS CUI [4]
C0005841
patients must have a karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.
Description

Karnofsky performance status and life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C0023671
patients must have adequate renal function (defined as serum creatinine <1.5 x upper limit of normal [uln]) and hepatic function (defined as total bilirubin <1.5 x uln and ast <3 x uln) within 14 days of study entry. for patients with autoimmune hemolytic anemia, the bilirubin must be less than or equal to 8 x uln.
Description

Renal function and liver function

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201913
UMLS CUI [3]
C0201899
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have received prior therapy with cytotoxic chemotherapy or immunosuppressants (with the exception of maintenance prednisone therapy not to exceed a dose of 20 mg/day for autoimmune hemolysis only) within four weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. the prednisone must have been started more than 4 weeks prior to study entry.
Description

Chemotherapy, Immunosuppression and Toxicity

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021081
UMLS CUI [3]
C0600688
patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.
Description

Radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
patients with new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
Description

Cardiac status and comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C1319795
UMLS CUI [2]
C1319796
UMLS CUI [3]
C0009488
patients with active obstructive hydronephrosis.
Description

active obstructive hydronephrosis

Data type

boolean

Alias
UMLS CUI [1]
C0020295
patients with prior malignancy other than cll, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. patients who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study entry to rule out recurrent disease.
Description

Further malignancies

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0007114
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C2216722
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0242793
patients with known hiv infection.
Description

HIV infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
patients who are pregnant or nursing. patients of childbearing potential must undergo a serum pregnancy test within 7 days prior to study entry. males and females must agree to use a contraceptive method from enrollment to 6 months after receiving iodine-131 anti-b1 antibody.
Description

Pregnancy and Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0430060
UMLS CUI [3]
C0700589
patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
Description

Chemotherapy and biologic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0005527
patients with evidence of active infection requiring intravenous treatment with anti-infectives.
Description

Infection requiring intravenous treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1411942
patients known to be hama positive.
Description

Hama positive

Data type

boolean

Alias
UMLS CUI [1]
C1291910
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Similar models

Eligibility Chronic Lymphocytic Leukemia NCT00022880

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Intermediate-risk b-cell cll or high-risk b-cell cll
Item
patients must fulfill the criteria for the diagnosis of intermediate-risk b-cell cll or high-risk b-cell cll
boolean
C3640764 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0332167 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
Nucleated cells on bone marrow aspirate
Item
the bone marrow aspirate must demonstrate that greater than or equal to 30% of all nucleated cells are lymphoid.
boolean
C1180059 (UMLS CUI [1,1])
C1271729 (UMLS CUI [1,2])
Leukemic lymphocytes: cd20 antigen positivity
Item
patients must have evidence that their leukemic lymphocytes express the cd20 antigen.
boolean
C0054946 (UMLS CUI [1,1])
C1517808 (UMLS CUI [1,2])
Treatment status
Item
patients must have been previously treated with chemotherapy or biologic therapy and have progressed on, failed to achieve an objective response (cr or partial response [pr]) on, or progressed after completion of last therapy. patients must have received at least one therapy containing a purine nucleoside analogue. patients must not have received more than 4 prior therapies. this includes both chemotherapy and biologic therapy.
boolean
C0392920 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
C1704632 (UMLS CUI [3])
C1268902 (UMLS CUI [4])
C2348184 (UMLS CUI [5])
Blood examination
Item
patients must have an absolute granulocyte count >500 cells/mm3 and a platelet count of either >100,000 cells/mm3 (cohort a) or a platelet count of 75,000-100,000 cells/mm3 deemed to be secondary to cll by the investigator, (cohort b) within 14 days of study entry. these blood counts must be sustained for 4 weeks without support of hematopoietic cytokines or transfusion of blood products.
boolean
C0857490 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0018928 (UMLS CUI [3])
C0005841 (UMLS CUI [4])
Karnofsky performance status and life expectancy
Item
patients must have a karnofsky performance status of at least 60% and an anticipated survival of at least 3 months.
boolean
C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Renal function and liver function
Item
patients must have adequate renal function (defined as serum creatinine <1.5 x upper limit of normal [uln]) and hepatic function (defined as total bilirubin <1.5 x uln and ast <3 x uln) within 14 days of study entry. for patients with autoimmune hemolytic anemia, the bilirubin must be less than or equal to 8 x uln.
boolean
C0201976 (UMLS CUI [1])
C0201913 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Chemotherapy, Immunosuppression and Toxicity
Item
patients who have received prior therapy with cytotoxic chemotherapy or immunosuppressants (with the exception of maintenance prednisone therapy not to exceed a dose of 20 mg/day for autoimmune hemolysis only) within four weeks prior to study entry (6 weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. the prednisone must have been started more than 4 weeks prior to study entry.
boolean
C0392920 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C0600688 (UMLS CUI [3])
Radiotherapy
Item
patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.
boolean
C1522449 (UMLS CUI [1])
Cardiac status and comorbidity
Item
patients with new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
boolean
C1319795 (UMLS CUI [1])
C1319796 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
active obstructive hydronephrosis
Item
patients with active obstructive hydronephrosis.
boolean
C0020295 (UMLS CUI [1])
Further malignancies
Item
patients with prior malignancy other than cll, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years. patients who have been disease-free of another cancer for greater than 5 years must be carefully assessed at the time of study entry to rule out recurrent disease.
boolean
C0006826 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0007114 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C2216722 (UMLS CUI [2,3])
C0006826 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0242793 (UMLS CUI [3,3])
HIV infection
Item
patients with known hiv infection.
boolean
C0019693 (UMLS CUI [1])
Pregnancy and Contraceptive methods
Item
patients who are pregnant or nursing. patients of childbearing potential must undergo a serum pregnancy test within 7 days prior to study entry. males and females must agree to use a contraceptive method from enrollment to 6 months after receiving iodine-131 anti-b1 antibody.
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Chemotherapy and biologic therapy
Item
patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
boolean
C0392920 (UMLS CUI [1])
C0005527 (UMLS CUI [2])
Infection requiring intravenous treatment
Item
patients with evidence of active infection requiring intravenous treatment with anti-infectives.
boolean
C0009450 (UMLS CUI [1,1])
C1411942 (UMLS CUI [1,2])
Hama positive
Item
patients known to be hama positive.
boolean
C1291910 (UMLS CUI [1])
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