ID

16951

Beskrivning

Non-Myeloablative Allogeneic Stem Cell Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT00525876

Länk

https://clinicaltrials.gov/show/NCT00525876

Nyckelord

Versioner (1)
  1. 2016-08-15 2016-08-15 -
Uppladdad den

15 augusti 2016

DOI

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Creative Commons BY 4.0
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Eligibility Lymphoma NCT00525876

Engelsk

Eligibility Lymphoma NCT00525876

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00525876
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients can be as old as 70 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. they must have a diagnosis of mcl, either (1) recurrent, (2) newly diagnosed (after cytoreduction with conventional chemotherapy) but with high-risk features (blastic or blastoid features, leukemic phase, or elevated b^2 microglobulin (> 3).
Beskrivning

Recurrent MCL or newly diagnosed MCL with high risk features

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0334634
UMLS CUI [1,2]
C0277556
UMLS CUI [2,1]
C0334634
UMLS CUI [2,2]
C0852709
UMLS CUI [3,1]
C0334634
UMLS CUI [3,2]
C0201910
UMLS CUI [4]
C1332569
3. patients that have received prior conventional chemotherapy but have not achieved complete response (cr).
Beskrivning

Patients that have received prior conventional chemotherapy but have not achieved complete response

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0521982
4. disease must be chemosensitive, (ie, patients must not have had a partial response to prior therapy).
Beskrivning

Chemosensitivity

Datatyp

boolean

Alias
UMLS CUI [1]
C2347610
5. patients whose disease failed to respond to a previous autologous transplantation may also be eligible.
Beskrivning

Patients whose disease failed to respond to a previous autologous transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040736
UMLS CUI [1,2]
C3844738
6. patients must have a matched or 1 antigen mismatched sibling or unrelated donor.
Beskrivning

Matched or 1 antigen mismatched sibling or unrelated donor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0375877
UMLS CUI [1,2]
C0019633
7. point scale (ps) </= 2.
Beskrivning

ECOG

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
8. inclusion criteria for immunomodulation post transplantation: patients can be as old as 70 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
9. patients must have a diagnosis of mcl or cll with one of the following characteristics: 1. patients who develop disease progression or do not experience a cr within 3 months post-allogeneic transplantation 2. patients with a weak chimerism (any mixed chimerism of donor t cells in patients receiving campath by day 90, and less than 20% for patients not receiving campath) or a drop of 20% or more with an amount of donor cells present in the blood < 50% by pcr. patients must have the same donor of the original transplant willing to donate lymphocytes. 4. ps </ 2.
Beskrivning

Inclusion Criteria for Immunomodulation: MCL or CLL

Datatyp

boolean

Alias
UMLS CUI [1]
C0334634
UMLS CUI [2]
C0023434
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C2242529
UMLS CUI [4,1]
C0521982
UMLS CUI [4,2]
C2242529
UMLS CUI [5]
C3703928
UMLS CUI [6,1]
C1512034
UMLS CUI [6,2]
C0375877
UMLS CUI [7]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. past history of anaphylaxis following exposure to rat- or mouse-derived cdr-grafted humanized monoclonal antibodies.
Beskrivning

history of anaphylaxis following exposure to rat- or mouse-derived cdr-grafted humanized monoclonal antibodies

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2985546
2. less than 4 weeks since prior chemotherapy counted from first day of treatment regimen.
Beskrivning

Latest chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
3. pregnancy or lactation.
Beskrivning

pregnancy or lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. hiv or htlv-i positivity.
Beskrivning

HIV or HTLV-I positivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0020097
5. serum creatinine concentration > 1.6 mg/dl or serum bilirubin > 2.0 mg/dl unless due to tumor
Beskrivning

Serum creatinine, serum bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0428441
6. pulmonary function test - carbon monoxide diffusing capacity < 40%
Beskrivning

carbon monoxide diffusing capacity

Datatyp

boolean

Alias
UMLS CUI [1]
C0199525
7. cardiac ejection fraction < 40% of predicted levels (by multiple-gated acquisition or echocardiography).
Beskrivning

Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0232174
8. severe concomitant medical or psychiatric illness.
Beskrivning

concomitant medical or psychiatric illness

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
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Similar models

Eligibility Lymphoma NCT00525876

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00525876
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients can be as old as 70 years.
boolean
C0001779 (UMLS CUI [1])
Recurrent MCL or newly diagnosed MCL with high risk features
Item
2. they must have a diagnosis of mcl, either (1) recurrent, (2) newly diagnosed (after cytoreduction with conventional chemotherapy) but with high-risk features (blastic or blastoid features, leukemic phase, or elevated b^2 microglobulin (> 3).
boolean
C0334634 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C0334634 (UMLS CUI [2,1])
C0852709 (UMLS CUI [2,2])
C0334634 (UMLS CUI [3,1])
C0201910 (UMLS CUI [3,2])
C1332569 (UMLS CUI [4])
Patients that have received prior conventional chemotherapy but have not achieved complete response
Item
3. patients that have received prior conventional chemotherapy but have not achieved complete response (cr).
boolean
C0392920 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
Chemosensitivity
Item
4. disease must be chemosensitive, (ie, patients must not have had a partial response to prior therapy).
boolean
C2347610 (UMLS CUI [1])
Patients whose disease failed to respond to a previous autologous transplantation
Item
5. patients whose disease failed to respond to a previous autologous transplantation may also be eligible.
boolean
C0040736 (UMLS CUI [1,1])
C3844738 (UMLS CUI [1,2])
Matched or 1 antigen mismatched sibling or unrelated donor
Item
6. patients must have a matched or 1 antigen mismatched sibling or unrelated donor.
boolean
C0375877 (UMLS CUI [1,1])
C0019633 (UMLS CUI [1,2])
ECOG
Item
7. point scale (ps) </= 2.
boolean
C1520224 (UMLS CUI [1])
Age
Item
8. inclusion criteria for immunomodulation post transplantation: patients can be as old as 70 years.
boolean
C0001779 (UMLS CUI [1])
Inclusion Criteria for Immunomodulation: MCL or CLL
Item
9. patients must have a diagnosis of mcl or cll with one of the following characteristics: 1. patients who develop disease progression or do not experience a cr within 3 months post-allogeneic transplantation 2. patients with a weak chimerism (any mixed chimerism of donor t cells in patients receiving campath by day 90, and less than 20% for patients not receiving campath) or a drop of 20% or more with an amount of donor cells present in the blood < 50% by pcr. patients must have the same donor of the original transplant willing to donate lymphocytes. 4. ps </ 2.
boolean
C0334634 (UMLS CUI [1])
C0023434 (UMLS CUI [2])
C0242656 (UMLS CUI [3,1])
C2242529 (UMLS CUI [3,2])
C0521982 (UMLS CUI [4,1])
C2242529 (UMLS CUI [4,2])
C3703928 (UMLS CUI [5])
C1512034 (UMLS CUI [6,1])
C0375877 (UMLS CUI [6,2])
C1520224 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
history of anaphylaxis following exposure to rat- or mouse-derived cdr-grafted humanized monoclonal antibodies
Item
1. past history of anaphylaxis following exposure to rat- or mouse-derived cdr-grafted humanized monoclonal antibodies.
boolean
C0020517 (UMLS CUI [1,1])
C2985546 (UMLS CUI [1,2])
Latest chemotherapy
Item
2. less than 4 weeks since prior chemotherapy counted from first day of treatment regimen.
boolean
C0392920 (UMLS CUI [1])
pregnancy or lactation
Item
3. pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV or HTLV-I positivity
Item
4. hiv or htlv-i positivity.
boolean
C0019699 (UMLS CUI [1])
C0020097 (UMLS CUI [2])
Serum creatinine, serum bilirubin
Item
5. serum creatinine concentration > 1.6 mg/dl or serum bilirubin > 2.0 mg/dl unless due to tumor
boolean
C0201976 (UMLS CUI [1])
C0428441 (UMLS CUI [2])
carbon monoxide diffusing capacity
Item
6. pulmonary function test - carbon monoxide diffusing capacity < 40%
boolean
C0199525 (UMLS CUI [1])
Cardiac ejection fraction
Item
7. cardiac ejection fraction < 40% of predicted levels (by multiple-gated acquisition or echocardiography).
boolean
C0232174 (UMLS CUI [1])
concomitant medical or psychiatric illness
Item
8. severe concomitant medical or psychiatric illness.
boolean
C0009488 (UMLS CUI [1])
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