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ID

16951

Description

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

Link

https://clinicaltrials.gov/show/NCT00525876

Keywords

Versions (1)
  1. 8/15/16 8/15/16 -
Uploaded on

August 15, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Lymphoma NCT00525876

    English

    Eligibility Lymphoma NCT00525876

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT00525876
    Inclusion Criteria
    Description

    Inclusion Criteria

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

    Age

    Data type

    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).
    Description

    Recurrent MCL or newly diagnosed MCL with high risk features

    Data type

    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).
    Description

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

    Data type

    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).
    Description

    Chemosensitivity

    Data type

    boolean

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

    Patients whose disease failed to respond to a previous autologous transplantation

    Data type

    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.
    Description

    Matched or 1 antigen mismatched sibling or unrelated donor

    Data type

    boolean

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

    ECOG

    Data type

    boolean

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

    Age

    Data type

    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.
    Description

    Inclusion Criteria for Immunomodulation: MCL or CLL

    Data type

    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
    Description

    Exclusion Criteria

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

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

    Data type

    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.
    Description

    Latest chemotherapy

    Data type

    boolean

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

    pregnancy or lactation

    Data type

    boolean

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

    HIV or HTLV-I positivity

    Data type

    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
    Description

    Serum creatinine, serum bilirubin

    Data type

    boolean

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

    carbon monoxide diffusing capacity

    Data type

    boolean

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

    Cardiac ejection fraction

    Data type

    boolean

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

    concomitant medical or psychiatric illness

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488
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    Similar models

    Eligibility Lymphoma NCT00525876

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT00525876
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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