ID

13338

Beschreibung

Donor Lymphocyte Infusion (DLI) for Relapsed (Post Transplant) Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00167167

Link

https://clinicaltrials.gov/show/NCT00167167

Stichworte

Versionen (1)
  1. 06.02.16 06.02.16 -
Hochgeladen am

6. Februar 2016

DOI

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Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Chronic NCT00167167

Englisch

Eligibility Leukemia, Myeloid, Chronic NCT00167167

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with cml, aml, mds or all relapsed after related or unrelated donor allogeneic marrow transplantation.
Beschreibung

cml, aml, mds or all relapsed after donor allogeneic marrow transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0023474
UMLS CUI [2]
C0023467
UMLS CUI [3]
C3463824
UMLS CUI [4]
C0023449
UMLS CUI [5]
C0277556
UMLS CUI [6]
C0149615
patients must be within one year of identification of relapse or if beyond that time period, must have some evidence of donor dna by rflp or cytogenetics.
Beschreibung

within one year of identification of relapse or evidence of donor dna

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C0181074
UMLS CUI [3]
C0035268
UMLS CUI [4]
C0010802
patients may have evidence of relapse based on molecular, cytogenetic or morphologic criteria.
Beschreibung

evidence of relapse

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0332120
cml patients must have cytogenetic evidence of relapse or if ph negative to start, obvious evidence of relapse other than minimal residual disease.
Beschreibung

cml - evidence of relapse

Datentyp

boolean

Alias
UMLS CUI [1]
C0023474
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0332120
patients must have <30% marrow blasts on a marrow biopsy performed within two weeks of the first donor lymphocyte infusion.
Beschreibung

marrow blasts

Datentyp

boolean

Alias
UMLS CUI [1]
C1982687
patients with >30% blasts can become eligible for donor lymphocytes after reinduction with any standard therapy regimen.
Beschreibung

>30% blasts, reinduction

Datentyp

boolean

Alias
UMLS CUI [1]
C1982687
UMLS CUI [2]
C3179010
patients with aml, mds or all achieving a cr with standard therapy regimens are eligible for this protocol.
Beschreibung

Complete remission

Datentyp

boolean

Alias
UMLS CUI [1]
C0677874
patients who relapse with their initial disease or develop a second malignancy after related or unrelated donor allogeneic marrow transplantation with other initial diagnoses (such as but not limited to cll, lymphoma, myeloma, juvenile cml, sarcoma, breast cancer) may also be included in this protocol. patients will be eligible with or without other adjunct chemotherapy or radiation therapy. post-transplant lymphomas (often referred to as ebv-associated lymphomas) will be eligible for donor leukocyte infusions on this protocol. treatment with donor leukocytes under this protocol is restricted to malignant diseases only. graft failure or relapse of non-malignant disorders is excluded from receiving donor leukocyte infusions on this protocol. autologous transplant patients who relapse are not eligible for this protocol. patients with malignant diseases amenable to other curative therapy are not eligible (i.e. skin cancers).
Beschreibung

recurrent disease, secondary malignancies, adjuvant therapy, post-transplant lymphomas (malignant), graft failure, non-malignant relapses, malignant disease curable with other treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C3266877
UMLS CUI [3]
C0392920
UMLS CUI [4]
C1522449
UMLS CUI [5,1]
C0432487
UMLS CUI [5,2]
C0205282
UMLS CUI [6]
C1262018
UMLS CUI [7]
C0194037
UMLS CUI [8,1]
C0006826
UMLS CUI [8,2]
C1273390
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with concurrent signs of acute or chronic graft-versus-host disease requiring ongoing treatment at the time of relapse will be ineligible.
Beschreibung

graft-versus-host disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018133
UMLS CUI [1,2]
C0087111
patients with >30% marrow blasts at the time of therapy will be ineligible.
Beschreibung

>30% marrow blasts

Datentyp

boolean

Alias
UMLS CUI [1]
C1982687
patients on prednisone, cyclosporine, imuran or other immunosuppressive medications are not eligible until these medications are discontinued for at least 2 weeks without a flare of gvhd.
Beschreibung

immunosuppressive therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
cml patients in complete cytogenetic remission who are bcr/abl positive by pcr only are not eligible.
Beschreibung

cml in complete remission, bcr/abl positive by pcr

Datentyp

boolean

Alias
UMLS CUI [1]
C0023474
UMLS CUI [2]
C0677874
UMLS CUI [3]
C1835417
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Ähnliche Modelle

Eligibility Leukemia, Myeloid, Chronic NCT00167167

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
cml, aml, mds or all relapsed after donor allogeneic marrow transplantation
Item
patients with cml, aml, mds or all relapsed after related or unrelated donor allogeneic marrow transplantation.
boolean
C0023474 (UMLS CUI [1])
C0023467 (UMLS CUI [2])
C3463824 (UMLS CUI [3])
C0023449 (UMLS CUI [4])
C0277556 (UMLS CUI [5])
C0149615 (UMLS CUI [6])
within one year of identification of relapse or evidence of donor dna
Item
patients must be within one year of identification of relapse or if beyond that time period, must have some evidence of donor dna by rflp or cytogenetics.
boolean
C0277556 (UMLS CUI [1])
C0181074 (UMLS CUI [2])
C0035268 (UMLS CUI [3])
C0010802 (UMLS CUI [4])
evidence of relapse
Item
patients may have evidence of relapse based on molecular, cytogenetic or morphologic criteria.
boolean
C0277556 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
cml - evidence of relapse
Item
cml patients must have cytogenetic evidence of relapse or if ph negative to start, obvious evidence of relapse other than minimal residual disease.
boolean
C0023474 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
marrow blasts
Item
patients must have <30% marrow blasts on a marrow biopsy performed within two weeks of the first donor lymphocyte infusion.
boolean
C1982687 (UMLS CUI [1])
>30% blasts, reinduction
Item
patients with >30% blasts can become eligible for donor lymphocytes after reinduction with any standard therapy regimen.
boolean
C1982687 (UMLS CUI [1])
C3179010 (UMLS CUI [2])
Complete remission
Item
patients with aml, mds or all achieving a cr with standard therapy regimens are eligible for this protocol.
boolean
C0677874 (UMLS CUI [1])
recurrent disease, secondary malignancies, adjuvant therapy, post-transplant lymphomas (malignant), graft failure, non-malignant relapses, malignant disease curable with other treatment
Item
patients who relapse with their initial disease or develop a second malignancy after related or unrelated donor allogeneic marrow transplantation with other initial diagnoses (such as but not limited to cll, lymphoma, myeloma, juvenile cml, sarcoma, breast cancer) may also be included in this protocol. patients will be eligible with or without other adjunct chemotherapy or radiation therapy. post-transplant lymphomas (often referred to as ebv-associated lymphomas) will be eligible for donor leukocyte infusions on this protocol. treatment with donor leukocytes under this protocol is restricted to malignant diseases only. graft failure or relapse of non-malignant disorders is excluded from receiving donor leukocyte infusions on this protocol. autologous transplant patients who relapse are not eligible for this protocol. patients with malignant diseases amenable to other curative therapy are not eligible (i.e. skin cancers).
boolean
C0277556 (UMLS CUI [1])
C3266877 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0432487 (UMLS CUI [5,1])
C0205282 (UMLS CUI [5,2])
C1262018 (UMLS CUI [6])
C0194037 (UMLS CUI [7])
C0006826 (UMLS CUI [8,1])
C1273390 (UMLS CUI [8,2])
Item Group
C0680251 (UMLS CUI)
graft-versus-host disease
Item
patients with concurrent signs of acute or chronic graft-versus-host disease requiring ongoing treatment at the time of relapse will be ineligible.
boolean
C0018133 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
>30% marrow blasts
Item
patients with >30% marrow blasts at the time of therapy will be ineligible.
boolean
C1982687 (UMLS CUI [1])
immunosuppressive therapy
Item
patients on prednisone, cyclosporine, imuran or other immunosuppressive medications are not eligible until these medications are discontinued for at least 2 weeks without a flare of gvhd.
boolean
C0021081 (UMLS CUI [1])
cml in complete remission, bcr/abl positive by pcr
Item
cml patients in complete cytogenetic remission who are bcr/abl positive by pcr only are not eligible.
boolean
C0023474 (UMLS CUI [1])
C0677874 (UMLS CUI [2])
C1835417 (UMLS CUI [3])
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