ID

43710

Descripción

Monoclonal Antibody (mAb) 216 With Chemotherapy in Adult Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00313079

Link

https://clinicaltrials.gov/show/NCT00313079

Palabras clave

Versiones (2)
  1. 6/5/17 6/5/17 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Leukemia, Lymphocytic NCT00313079

Inglés

Eligibility Leukemia, Lymphocytic NCT00313079

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
3.1.1 age patients must be >= 18 years old at the time of study entry.
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
3.1.2 diagnosis
Descripción

diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011900
3.1.2.1 histologic verification patients must have had histologic verification of b-lineage all with bone marrow relapse or refractory disease that is unresponsive to traditional chemotherapy.
Descripción

b-cell acute lymphocytic leukemia with bone marrow relapse or unresponsive to chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023449
UMLS CUI [1,2]
C0004561
UMLS CUI [1,3]
C0005953
UMLS CUI [1,4]
C0035020
UMLS CUI [1,5]
C0205269
UMLS CUI [1,6]
C0392920
3.1.2.2 for patients without prior allogeneic bmt:
Descripción

allogeneic bone marrow transplant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005961
1. second or subsequent bone marrow relapse
Descripción

bone marrow relapses

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0035020
2. primary refractory marrow disease
Descripción

refractory marrow disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005956
UMLS CUI [1,2]
C0205269
3. m3 marrow (>25% blasts) or >25% leukemic blasts in peripheral blood
Descripción

leukemic blasts in bone marrow and peripheral blood

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0877255
UMLS CUI [2,1]
C2697913
UMLS CUI [2,2]
C0229664
3.1.2.3 for patients with prior allogeneic bmt:
Descripción

allogeneic bone marrow transplant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005961
1. first or subsequent bone marrow relapse post-bmt
Descripción

bone marrow relapse after bone marrow transplant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0035020
UMLS CUI [1,3]
C0005961
2. m3 marrow or m2 (>5 % and <25% blasts) if cytogenetic or vntr confirmation
Descripción

m3 bone marrow or m2 with cytogenetic or vntr confirmation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877255
UMLS CUI [1,2]
C0010802
UMLS CUI [1,3]
C0242827
3.1.3 confirmation of antibody reactivity 3.1.3.1 patient's leukemic blasts (peripheral blood or marrow) must be documented to bind mab 216 in vitro (teng lab) 3.1.3.2 patient's rbc documented to not express fetal "i" antigen and rbc shown to not bind mab 216 in vitro (teng lab)
Descripción

leukemic blasts binding mab, erythrocytes expression fetal i antigen and binding mab

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1517806
UMLS CUI [1,2]
C1167622
UMLS CUI [1,3]
C0003250
UMLS CUI [2,1]
C0014792
UMLS CUI [2,2]
C0312890
UMLS CUI [2,3]
C1167622
UMLS CUI [2,4]
C0003250
3.1.4 patient must not be eligible for therapies of higher priority
Descripción

eligibility higher priority therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018736
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0013893
3.1.5 performance level (see appendix i) karnofsky >= 50%
Descripción

karnofsky performance level

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
3.1.6 life expectancy must be at least 8 weeks.
Descripción

life expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
3.1.7 prior therapy patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Descripción

recovered from toxic effects of prior therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0600688
UMLS CUI [1,3]
C2826210
1. myelosuppressive chemotherapy: must not have received within one week of entry onto this study.
Descripción

myelosuppressive chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1513793
2. biologic, including monoclonal antibodies: at least 2 weeks since the completion of therapy with a biologic agent including monoclonal antibodies.
Descripción

biologic agent including monoclonal antibodies

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C0003250
3. hydroxyurea can be used up to 72 hours before study entry
Descripción

hydroxyurea

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020402
3.1.8 organ function requirements
Descripción

organ function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
3.1.8.1 bone marrow function: 3.1.8.1.1 no hematologic criteria for wbc, hgb or platelets 3.1.8.1.2 patients with thrombocytopenia should be responsive to platelet transfusions and must not have uncontrolled bleeding.
Descripción

bone marrow function, wbc, hgb, platelets, thrombocytopenia, platelet transfusion, uncontrolled bleeding

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0023508
UMLS CUI [1,3]
C0019046
UMLS CUI [1,4]
C0005821
UMLS CUI [2,1]
C0040034
UMLS CUI [2,2]
C0086818
UMLS CUI [2,3]
C3842135
3.1.8.2 adequate renal function defined as:
Descripción

renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
a serum creatinine that is less than or equal to 2 x normal for age
Descripción

serum creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
3.1.8.3 adequate liver function defined as:
Descripción

liver function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
total bilirubin <= 2 x upper limit of normal (uln) for age, and
Descripción

total bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201913
sgpt (alt) <= 5 x upper limit of normal (uln) for age
Descripción

sgpt

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201836
3.1.8.4 adequate cardiac function defined as:
Descripción

cardiac function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232164
shortening fraction of >= 27% by echocardiogram, or
Descripción

shortening fraction by echocardiography

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1335957
UMLS CUI [1,2]
C0013516
ejection fraction of >= 50% by gated radionuclide study.
Descripción

ejection fraction by gated radionuclide study

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0232174
UMLS CUI [1,2]
C0017200
3.1.9 regulatory
Descripción

regulatory

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220905
3.1.9.1 all patients must sign a written informed consent. 3.1.9.2 all institutional (irb) and fda requirements for human studies must be met.
Descripción

informed consent, requirements for human studies

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0178693
UMLS CUI [2,2]
C1514873
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
3.2.1 cns 3 or refractory cns leukemia
Descripción

cns leukemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1332884
3.2.2 isolated extramedullary relapse
Descripción

extramedullary relapse

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1517060
3.2.3 uncontrolled infection
Descripción

uncontrolled infection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
3.2.4 lack of mab 216 binding to patient's leukemic blasts in vitro
Descripción

leukemic blast binding mab

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1517806
UMLS CUI [1,2]
C1167622
UMLS CUI [1,3]
C0003250
3.2.5 binding of mab 216 to the "i" antigen on patient's erythrocytes
Descripción

mab binding i antigen on erythrocytes

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0014792
UMLS CUI [1,2]
C0312890
UMLS CUI [1,3]
C1167622
UMLS CUI [1,4]
C0003250
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Similar models

Eligibility Leukemia, Lymphocytic NCT00313079

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
3.1.1 age patients must be >= 18 years old at the time of study entry.
boolean
C0001779 (UMLS CUI [1])
diagnosis
Item
3.1.2 diagnosis
boolean
C0011900 (UMLS CUI [1])
b-cell acute lymphocytic leukemia with bone marrow relapse or unresponsive to chemotherapy
Item
3.1.2.1 histologic verification patients must have had histologic verification of b-lineage all with bone marrow relapse or refractory disease that is unresponsive to traditional chemotherapy.
boolean
C0023449 (UMLS CUI [1,1])
C0004561 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,3])
C0035020 (UMLS CUI [1,4])
C0205269 (UMLS CUI [1,5])
C0392920 (UMLS CUI [1,6])
allogeneic bone marrow transplant
Item
3.1.2.2 for patients without prior allogeneic bmt:
boolean
C0005961 (UMLS CUI [1])
bone marrow relapses
Item
1. second or subsequent bone marrow relapse
boolean
C0005953 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
refractory marrow disease
Item
2. primary refractory marrow disease
boolean
C0005956 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
leukemic blasts in bone marrow and peripheral blood
Item
3. m3 marrow (>25% blasts) or >25% leukemic blasts in peripheral blood
boolean
C0877255 (UMLS CUI [1])
C2697913 (UMLS CUI [2,1])
C0229664 (UMLS CUI [2,2])
allogeneic bone marrow transplant
Item
3.1.2.3 for patients with prior allogeneic bmt:
boolean
C0005961 (UMLS CUI [1])
bone marrow relapse after bone marrow transplant
Item
1. first or subsequent bone marrow relapse post-bmt
boolean
C0005953 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0005961 (UMLS CUI [1,3])
m3 bone marrow or m2 with cytogenetic or vntr confirmation
Item
2. m3 marrow or m2 (>5 % and <25% blasts) if cytogenetic or vntr confirmation
boolean
C0877255 (UMLS CUI [1,1])
C0010802 (UMLS CUI [1,2])
C0242827 (UMLS CUI [1,3])
leukemic blasts binding mab, erythrocytes expression fetal i antigen and binding mab
Item
3.1.3 confirmation of antibody reactivity 3.1.3.1 patient's leukemic blasts (peripheral blood or marrow) must be documented to bind mab 216 in vitro (teng lab) 3.1.3.2 patient's rbc documented to not express fetal "i" antigen and rbc shown to not bind mab 216 in vitro (teng lab)
boolean
C1517806 (UMLS CUI [1,1])
C1167622 (UMLS CUI [1,2])
C0003250 (UMLS CUI [1,3])
C0014792 (UMLS CUI [2,1])
C0312890 (UMLS CUI [2,2])
C1167622 (UMLS CUI [2,3])
C0003250 (UMLS CUI [2,4])
eligibility higher priority therapy
Item
3.1.4 patient must not be eligible for therapies of higher priority
boolean
C0018736 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013893 (UMLS CUI [1,3])
karnofsky performance level
Item
3.1.5 performance level (see appendix i) karnofsky >= 50%
boolean
C0206065 (UMLS CUI [1])
life expectancy
Item
3.1.6 life expectancy must be at least 8 weeks.
boolean
C0023671 (UMLS CUI [1])
recovered from toxic effects of prior therapy
Item
3.1.7 prior therapy patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
boolean
C1514463 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C2826210 (UMLS CUI [1,3])
myelosuppressive chemotherapy
Item
1. myelosuppressive chemotherapy: must not have received within one week of entry onto this study.
boolean
C0392920 (UMLS CUI [1,1])
C1513793 (UMLS CUI [1,2])
biologic agent including monoclonal antibodies
Item
2. biologic, including monoclonal antibodies: at least 2 weeks since the completion of therapy with a biologic agent including monoclonal antibodies.
boolean
C0005515 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
hydroxyurea
Item
3. hydroxyurea can be used up to 72 hours before study entry
boolean
C0020402 (UMLS CUI [1])
organ function
Item
3.1.8 organ function requirements
boolean
C0678852 (UMLS CUI [1])
bone marrow function, wbc, hgb, platelets, thrombocytopenia, platelet transfusion, uncontrolled bleeding
Item
3.1.8.1 bone marrow function: 3.1.8.1.1 no hematologic criteria for wbc, hgb or platelets 3.1.8.1.2 patients with thrombocytopenia should be responsive to platelet transfusions and must not have uncontrolled bleeding.
boolean
C0005953 (UMLS CUI [1,1])
C0023508 (UMLS CUI [1,2])
C0019046 (UMLS CUI [1,3])
C0005821 (UMLS CUI [1,4])
C0040034 (UMLS CUI [2,1])
C0086818 (UMLS CUI [2,2])
C3842135 (UMLS CUI [2,3])
renal function
Item
3.1.8.2 adequate renal function defined as:
boolean
C0232804 (UMLS CUI [1])
serum creatinine
Item
a serum creatinine that is less than or equal to 2 x normal for age
boolean
C0201976 (UMLS CUI [1])
liver function
Item
3.1.8.3 adequate liver function defined as:
boolean
C0232741 (UMLS CUI [1])
total bilirubin
Item
total bilirubin <= 2 x upper limit of normal (uln) for age, and
boolean
C0201913 (UMLS CUI [1])
sgpt
Item
sgpt (alt) <= 5 x upper limit of normal (uln) for age
boolean
C0201836 (UMLS CUI [1])
cardiac function
Item
3.1.8.4 adequate cardiac function defined as:
boolean
C0232164 (UMLS CUI [1])
shortening fraction by echocardiography
Item
shortening fraction of >= 27% by echocardiogram, or
boolean
C1335957 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
ejection fraction by gated radionuclide study
Item
ejection fraction of >= 50% by gated radionuclide study.
boolean
C0232174 (UMLS CUI [1,1])
C0017200 (UMLS CUI [1,2])
regulatory
Item
3.1.9 regulatory
boolean
C0220905 (UMLS CUI [1])
informed consent, requirements for human studies
Item
3.1.9.1 all patients must sign a written informed consent. 3.1.9.2 all institutional (irb) and fda requirements for human studies must be met.
boolean
C0021430 (UMLS CUI [1])
C0178693 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
cns leukemia
Item
3.2.1 cns 3 or refractory cns leukemia
boolean
C1332884 (UMLS CUI [1])
extramedullary relapse
Item
3.2.2 isolated extramedullary relapse
boolean
C0035020 (UMLS CUI [1,1])
C1517060 (UMLS CUI [1,2])
uncontrolled infection
Item
3.2.3 uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
leukemic blast binding mab
Item
3.2.4 lack of mab 216 binding to patient's leukemic blasts in vitro
boolean
C1517806 (UMLS CUI [1,1])
C1167622 (UMLS CUI [1,2])
C0003250 (UMLS CUI [1,3])
mab binding i antigen on erythrocytes
Item
3.2.5 binding of mab 216 to the "i" antigen on patient's erythrocytes
boolean
C0014792 (UMLS CUI [1,1])
C0312890 (UMLS CUI [1,2])
C1167622 (UMLS CUI [1,3])
C0003250 (UMLS CUI [1,4])
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