ID

16562

Description

Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00027560

Link

https://clinicaltrials.gov/show/NCT00027560

Keywords

Versions (1)
  1. 7/24/16 7/24/16 -
Uploaded on

July 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Leukemia NCT00027560

English

Eligibility Leukemia NCT00027560

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00027560
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
disease criteria: this trial is primarily designed for: 1) patients with relapsed or primary refractory non-hodgkin's lymphoma
Description

relapsed or primary refractory NHL

Data type

boolean

Alias
UMLS CUI [1]
C0024305
disease criteria: this trial is primarily designed for: 2) chemosensitive relapsed or refractory acute and chronic lymphocytic leukemias
Description

chemosensitive leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023418
disease criteria: this trial is primarily designed for: 3) relapsed or primary refractory hodgkin's disease, or advanced (durie-salmon stage ii or iii) multiple myeloma, advanced waldenstrom macroglobulinemia, who, by virtue of advanced age, intensity of prior radiation and/or chemotherapy, history of prior toxicity associated with chemo/radiotherapy or existing organ dysfunction, would be at undue risk of regimen associated mortality if transplanted according to protocols involving myeloablative conditioning regimens.
Description

Hodgkin lymphoma, multiple myeloma, advanced waldenstrom macroglobulinemia

Data type

boolean

Alias
UMLS CUI [1]
C0019829
UMLS CUI [2]
C0026764
UMLS CUI [3,1]
C0024419
UMLS CUI [3,2]
C0679246
patients with aggressive nhl histologies must have chemo/radiosensitive disease, or have non-progressive disease, or have stable disease on therapy, and be ineligible for an autologous hsc transplant because of disease in the marrow.
Description

patients with aggressive nhl histologies ineligible for an autologous hsc transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C1332225
UMLS CUI [1,2]
C2193200
UMLS CUI [1,3]
C0522473
patients with chronic myeloid leukemia and high risk forms of acute myelogenous leukemia or myelodysplastic syndromes are also eligible in the absence of an alternative active higher priority allogeneic transplant protocol for which they are eligible.
Description

eligible in the absence of an alternative active higher priority allogeneic transplant protocol for which they are eligible.

Data type

boolean

Alias
UMLS CUI [1,1]
C1523987
UMLS CUI [1,2]
C0149615
age criteria: patients may be up to 70 years of age. there is no lower age threshold. patients above the age of 70 may also participate, after evaluation and approval by the bmt service attendings.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
absence of active or uncontrolled bacterial, viral, or fungal infection that would contraindicate the use of myelosuppressive chemotherapy.
Description

active disease contraindication for myelosuppressive chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1513793
UMLS CUI [1,2]
C1301624
UMLS CUI [1,3]
C0009450
patients must have a healthy hla-compatible donor, either a matched or single hla allele disparate related donor or a similarly compatible unrelated donor recruited through the national marrow donor program. related donors must be willing to participate as research subjects and be willing to receive g-csf to mobilize pbpc and undergo leukapheresis to donate pbsc. unrelated donors identified by the nmdp may elect to donate either pbsc after treatment with g-csf, or bone marrow. these unrelated donors will provide informed consent and their pbsc or bone marrow donations will be obtained at a qualified donor center participating in the nmdp.
Description

hla compatible donor provide written informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0013018
UMLS CUI [1,3]
C2348930
each patient must be willing to participate as a research subject and must sign an informed consent form after discussion of the nature and risks of the study prior to entering the protocol. parents or legal guardians of patients who are minors will sign the consent form for these patients after discussion of the nature and risks of the study.
Description

patient informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female patients who are pregnant or lactating.
Description

pregnant or lactating

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
active or uncontrolled viral (including hiv-1), bacterial or fungal infection.
Description

communicable disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
severe renal insufficiency (creatinine >2.0 or creatinine clearance < 30ml/minute)
Description

severe renal insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0201976
severe hepatic dysfunction, as defined by: total bilirubin greater than 2.5 mg/dl and ast and alt >3xnl, unless the liver is involved with disease.
Description

severe hepatic dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0201913
severe cardiac insufficiency, defined as a resting left ventricular ejection of less than 30% as measured by echocardiography or radionuclide cardiac angiography. patients on cardiac medications for congestive heart failure are eligible, as long as their lvef is greater than 30% on medication.
Description

severe cardiac insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0392173
UMLS CUI [1,2]
C0428772
severe pulmonary insufficiency, as defined by an adjusted diffusing capacity of less than 40% of predicted value.
Description

severe pulmonary insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C3279625
karnofsky or lansky score <40%
Description

karnofsky or lansky score <40%

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1522275
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Similar models

Eligibility Leukemia NCT00027560

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00027560
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
relapsed or primary refractory NHL
Item
disease criteria: this trial is primarily designed for: 1) patients with relapsed or primary refractory non-hodgkin's lymphoma
boolean
C0024305 (UMLS CUI [1])
chemosensitive leukemia
Item
disease criteria: this trial is primarily designed for: 2) chemosensitive relapsed or refractory acute and chronic lymphocytic leukemias
boolean
C0023418 (UMLS CUI [1])
Hodgkin lymphoma, multiple myeloma, advanced waldenstrom macroglobulinemia
Item
disease criteria: this trial is primarily designed for: 3) relapsed or primary refractory hodgkin's disease, or advanced (durie-salmon stage ii or iii) multiple myeloma, advanced waldenstrom macroglobulinemia, who, by virtue of advanced age, intensity of prior radiation and/or chemotherapy, history of prior toxicity associated with chemo/radiotherapy or existing organ dysfunction, would be at undue risk of regimen associated mortality if transplanted according to protocols involving myeloablative conditioning regimens.
boolean
C0019829 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
C0024419 (UMLS CUI [3,1])
C0679246 (UMLS CUI [3,2])
patients with aggressive nhl histologies ineligible for an autologous hsc transplant
Item
patients with aggressive nhl histologies must have chemo/radiosensitive disease, or have non-progressive disease, or have stable disease on therapy, and be ineligible for an autologous hsc transplant because of disease in the marrow.
boolean
C1332225 (UMLS CUI [1,1])
C2193200 (UMLS CUI [1,2])
C0522473 (UMLS CUI [1,3])
eligible in the absence of an alternative active higher priority allogeneic transplant protocol for which they are eligible.
Item
patients with chronic myeloid leukemia and high risk forms of acute myelogenous leukemia or myelodysplastic syndromes are also eligible in the absence of an alternative active higher priority allogeneic transplant protocol for which they are eligible.
boolean
C1523987 (UMLS CUI [1,1])
C0149615 (UMLS CUI [1,2])
age
Item
age criteria: patients may be up to 70 years of age. there is no lower age threshold. patients above the age of 70 may also participate, after evaluation and approval by the bmt service attendings.
boolean
C0001779 (UMLS CUI [1])
active disease contraindication for myelosuppressive chemotherapy
Item
absence of active or uncontrolled bacterial, viral, or fungal infection that would contraindicate the use of myelosuppressive chemotherapy.
boolean
C1513793 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
hla compatible donor provide written informed consent
Item
patients must have a healthy hla-compatible donor, either a matched or single hla allele disparate related donor or a similarly compatible unrelated donor recruited through the national marrow donor program. related donors must be willing to participate as research subjects and be willing to receive g-csf to mobilize pbpc and undergo leukapheresis to donate pbsc. unrelated donors identified by the nmdp may elect to donate either pbsc after treatment with g-csf, or bone marrow. these unrelated donors will provide informed consent and their pbsc or bone marrow donations will be obtained at a qualified donor center participating in the nmdp.
boolean
C0021430 (UMLS CUI [1,1])
C0013018 (UMLS CUI [1,2])
C2348930 (UMLS CUI [1,3])
patient informed consent
Item
each patient must be willing to participate as a research subject and must sign an informed consent form after discussion of the nature and risks of the study prior to entering the protocol. parents or legal guardians of patients who are minors will sign the consent form for these patients after discussion of the nature and risks of the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant or lactating
Item
female patients who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
communicable disease
Item
active or uncontrolled viral (including hiv-1), bacterial or fungal infection.
boolean
C0009450 (UMLS CUI [1])
severe renal insufficiency
Item
severe renal insufficiency (creatinine >2.0 or creatinine clearance < 30ml/minute)
boolean
C1565489 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
severe hepatic dysfunction
Item
severe hepatic dysfunction, as defined by: total bilirubin greater than 2.5 mg/dl and ast and alt >3xnl, unless the liver is involved with disease.
boolean
C0086565 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
severe cardiac insufficiency
Item
severe cardiac insufficiency, defined as a resting left ventricular ejection of less than 30% as measured by echocardiography or radionuclide cardiac angiography. patients on cardiac medications for congestive heart failure are eligible, as long as their lvef is greater than 30% on medication.
boolean
C0392173 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
severe pulmonary insufficiency
Item
severe pulmonary insufficiency, as defined by an adjusted diffusing capacity of less than 40% of predicted value.
boolean
C3279625 (UMLS CUI [1])
karnofsky or lansky score <40%
Item
karnofsky or lansky score <40%
boolean
C0206065 (UMLS CUI [1])
C1522275 (UMLS CUI [2])
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