ID

31076

Beschreibung

Zevalin With Non Myeloablative Allogeneic Stem Cell Transplantation in Patients With Non Hodgkin Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00807196

Link

https://clinicaltrials.gov/show/NCT00807196

Stichworte

Versionen (1)
  1. 18.07.18 18.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. Juli 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Non-Hodgkins Lymphoma NCT00807196

Englisch

Eligibility Non-Hodgkins Lymphoma NCT00807196

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have/be
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. age 18 to 65 years. patients between age 66 and 69 may be enrolled if judged to be in excellent physical condition as per treating physician and study investigator and based on institutional practice.
Beschreibung

Age | Age Relationship Physical Condition Excellent

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C3714565
UMLS CUI [2,4]
C1961136
2. diagnosis of non-hodgkin lymphoma, follicular, marginal zone, small lymphocytic lymphoma, mantle cell lymphoma or transformed from an indolent nhl to aggressive histology disease lymphoma as defined by the world health organization.
Beschreibung

Lymphoma, Non-Hodgkin | Lymphoma, Follicular | Marginal Zone Lymphoma | Small Lymphocytic Lymphoma | Mantle cell lymphoma | Transformation Indolent Non-Hodgkin Lymphoma Aggressive Non-Hodgkin Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0024305
UMLS CUI [2]
C0024301
UMLS CUI [3]
C1367654
UMLS CUI [4]
C0855095
UMLS CUI [5]
C0334634
UMLS CUI [6,1]
C0040682
UMLS CUI [6,2]
C1334170
UMLS CUI [6,3]
C1332225
3. disease relapsed after, refractory or failing to achieve a pr after two or more cycles of intensive salvage chemotherapy (r-eshap or other) or disease relapsed after autologous stem cell transplantation. poor partial response is defined as less than 50% reduction of tumor size. salvage chemotherapy has to be administered after either 1st, 2nd or 3rd relapse
Beschreibung

Recurrent disease | Refractory Disease Post Cycle Quantity Salvage Therapy | Partial response failed | Status post Cycle Quantity Salvage Therapy | ESHAP regimen | Recurrent disease Post Transplantation of autologous hematopoietic stem cell

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C1514815
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C1302181
UMLS CUI [2,4]
C1265611
UMLS CUI [2,5]
C0085405
UMLS CUI [3,1]
C1521726
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1302181
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0085405
UMLS CUI [5]
C0384397
UMLS CUI [6,1]
C0277556
UMLS CUI [6,2]
C0687676
UMLS CUI [6,3]
C1831743
4. disease expressing the cd 20 antigen
Beschreibung

Disease CD20 Antigen Expressed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0054946
UMLS CUI [1,3]
C0017262
5. ecog performance status 0-2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
6. judged to be able to tolerate nst and zevalin treatment based on institutional criteria.
Beschreibung

Nonmyeloablative stem cell transplantation Receive Ability | Zevalin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1831742
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0085732
UMLS CUI [2]
C0919274
7. signed written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
8. at least one fully hla matched sibling without evident contraindications to the donation procedures and willing to sign consent for donation
Beschreibung

HLA Match Sibling Quantity | Absence Contraindication Tissue Donation | Consent Tissue Donation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4330149
UMLS CUI [1,2]
C0037047
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0522473
UMLS CUI [2,3]
C0080231
UMLS CUI [3,1]
C1511481
UMLS CUI [3,2]
C0080231
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not have/be
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. abnormal renal function (creatinine > 1.5 x upper limit of normal (uln)
Beschreibung

Abnormal renal function | Serum creatinine raised

Datentyp

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0700225
2. abnormal hepatic function (bilirubin > 2 x uln, alt/ast>2x uln)
Beschreibung

Liver Dysfunction | Serum bilirubin increased | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0859062
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151904
3. cardiac ejection fraction <40% and/or other significant cardiac compromise
Beschreibung

Cardiac ejection fraction | Decreased cardiac function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C0232166
4. severe defects in pulmonary function tests or receiving continuous oxygen
Beschreibung

Defect Severe Pulmonary function tests | Oxygen therapy support

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457869
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0024119
UMLS CUI [2]
C3872899
5. severe concurrent illness, such as symptomatic congestive heart failure, severe arrhythmias, uncontrolled hypertension, diabetes, severe neurologic or psychiatric disorder or known hiv positive
Beschreibung

Comorbidity Severe | Symptomatic congestive heart failure | Cardiac Arrhythmia Severe | Uncontrolled hypertension | Diabetes Mellitus | Nervous system disorder Severe | Mental Disorders, Severe | HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0742758
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C1868885
UMLS CUI [5]
C0011849
UMLS CUI [6,1]
C0027765
UMLS CUI [6,2]
C0205082
UMLS CUI [7]
C4046029
UMLS CUI [8]
C0019699
6. previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (ta, tis & t1) that may impact on patients life expectancy or any cancer curatively treated < 3 years prior to study entry.
Beschreibung

Cancer Other Primary site | Cancer Other Histology | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Superficial carcinoma of urinary bladder TNM clinical staging | Impact Life Expectancy | Exception Curative treatment Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0475447
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C4048239
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1336527
UMLS CUI [5,3]
C3258246
UMLS CUI [6,1]
C4049986
UMLS CUI [6,2]
C0023671
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1273390
UMLS CUI [7,3]
C0006826
7. history of prior allogeneic bone marrow transplant
Beschreibung

Allogeneic bone marrow transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0149615
8. evidence of active hepatitis b or c infection or positivity for hepatitis-b surface antigen
Beschreibung

Hepatitis B | Hepatitis C | Hepatitis B surface antigen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0149709
9. known type 1 hypersensitivity or anaphylactic proteins to any component of the zevalin therapy or a history or presence of human anti-mouse antibodies (hama)
Beschreibung

Immediate hypersensitivity Zevalin Component | Anaphylaxis Zevalin Component | Human anti-mouse antibody Present

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020523
UMLS CUI [1,2]
C0919274
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0919274
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C1291910
UMLS CUI [3,2]
C0150312
10. a female patient who is pregnant or breast feeding and an adult of reproductive potential who is not employing an effective method of birth control during the study.
Beschreibung

Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
11. cns lymphoma
Beschreibung

Central nervous system lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0742472
12. ongoing confirmed or suspected significant infection
Beschreibung

Communicable Disease | Communicable Disease Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0750491
13. prior treatment with radioimmunotherapy
Beschreibung

Radioimmunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0085101
14. other condition preventing participation in standard nst
Beschreibung

Condition Preventing Nonmyeloablative stem cell transplantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1831742
15. no fully matched sibling donor
Beschreibung

HLA Match Sibling Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4330149
UMLS CUI [1,2]
C0037047
UMLS CUI [1,3]
C0332268
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Ähnliche Modelle

Eligibility Non-Hodgkins Lymphoma NCT00807196

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients must have/be
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age | Age Relationship Physical Condition Excellent
Item
1. age 18 to 65 years. patients between age 66 and 69 may be enrolled if judged to be in excellent physical condition as per treating physician and study investigator and based on institutional practice.
boolean
C0001779 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C3714565 (UMLS CUI [2,3])
C1961136 (UMLS CUI [2,4])
Lymphoma, Non-Hodgkin | Lymphoma, Follicular | Marginal Zone Lymphoma | Small Lymphocytic Lymphoma | Mantle cell lymphoma | Transformation Indolent Non-Hodgkin Lymphoma Aggressive Non-Hodgkin Lymphoma
Item
2. diagnosis of non-hodgkin lymphoma, follicular, marginal zone, small lymphocytic lymphoma, mantle cell lymphoma or transformed from an indolent nhl to aggressive histology disease lymphoma as defined by the world health organization.
boolean
C0024305 (UMLS CUI [1])
C0024301 (UMLS CUI [2])
C1367654 (UMLS CUI [3])
C0855095 (UMLS CUI [4])
C0334634 (UMLS CUI [5])
C0040682 (UMLS CUI [6,1])
C1334170 (UMLS CUI [6,2])
C1332225 (UMLS CUI [6,3])
Recurrent disease | Refractory Disease Post Cycle Quantity Salvage Therapy | Partial response failed | Status post Cycle Quantity Salvage Therapy | ESHAP regimen | Recurrent disease Post Transplantation of autologous hematopoietic stem cell
Item
3. disease relapsed after, refractory or failing to achieve a pr after two or more cycles of intensive salvage chemotherapy (r-eshap or other) or disease relapsed after autologous stem cell transplantation. poor partial response is defined as less than 50% reduction of tumor size. salvage chemotherapy has to be administered after either 1st, 2nd or 3rd relapse
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C1302181 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0085405 (UMLS CUI [2,5])
C1521726 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C1302181 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0085405 (UMLS CUI [4,4])
C0384397 (UMLS CUI [5])
C0277556 (UMLS CUI [6,1])
C0687676 (UMLS CUI [6,2])
C1831743 (UMLS CUI [6,3])
Disease CD20 Antigen Expressed
Item
4. disease expressing the cd 20 antigen
boolean
C0012634 (UMLS CUI [1,1])
C0054946 (UMLS CUI [1,2])
C0017262 (UMLS CUI [1,3])
ECOG performance status
Item
5. ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Nonmyeloablative stem cell transplantation Receive Ability | Zevalin
Item
6. judged to be able to tolerate nst and zevalin treatment based on institutional criteria.
boolean
C1831742 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0919274 (UMLS CUI [2])
Informed Consent
Item
7. signed written informed consent
boolean
C0021430 (UMLS CUI [1])
HLA Match Sibling Quantity | Absence Contraindication Tissue Donation | Consent Tissue Donation
Item
8. at least one fully hla matched sibling without evident contraindications to the donation procedures and willing to sign consent for donation
boolean
C4330149 (UMLS CUI [1,1])
C0037047 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0522473 (UMLS CUI [2,2])
C0080231 (UMLS CUI [2,3])
C1511481 (UMLS CUI [3,1])
C0080231 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients must not have/be
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Abnormal renal function | Serum creatinine raised
Item
1. abnormal renal function (creatinine > 1.5 x upper limit of normal (uln)
boolean
C0151746 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Liver Dysfunction | Serum bilirubin increased | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
2. abnormal hepatic function (bilirubin > 2 x uln, alt/ast>2x uln)
boolean
C0086565 (UMLS CUI [1])
C0859062 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
Cardiac ejection fraction | Decreased cardiac function
Item
3. cardiac ejection fraction <40% and/or other significant cardiac compromise
boolean
C0232174 (UMLS CUI [1])
C0232166 (UMLS CUI [2])
Defect Severe Pulmonary function tests | Oxygen therapy support
Item
4. severe defects in pulmonary function tests or receiving continuous oxygen
boolean
C1457869 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,3])
C3872899 (UMLS CUI [2])
Comorbidity Severe | Symptomatic congestive heart failure | Cardiac Arrhythmia Severe | Uncontrolled hypertension | Diabetes Mellitus | Nervous system disorder Severe | Mental Disorders, Severe | HIV Seropositivity
Item
5. severe concurrent illness, such as symptomatic congestive heart failure, severe arrhythmias, uncontrolled hypertension, diabetes, severe neurologic or psychiatric disorder or known hiv positive
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0742758 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C1868885 (UMLS CUI [4])
C0011849 (UMLS CUI [5])
C0027765 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C4046029 (UMLS CUI [7])
C0019699 (UMLS CUI [8])
Cancer Other Primary site | Cancer Other Histology | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated | Exception Superficial carcinoma of urinary bladder TNM clinical staging | Impact Life Expectancy | Exception Curative treatment Malignant Neoplasms
Item
6. previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (ta, tis & t1) that may impact on patients life expectancy or any cancer curatively treated < 3 years prior to study entry.
boolean
C1707251 (UMLS CUI [1,1])
C0475447 (UMLS CUI [1,2])
C1707251 (UMLS CUI [2,1])
C4048239 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1336527 (UMLS CUI [5,2])
C3258246 (UMLS CUI [5,3])
C4049986 (UMLS CUI [6,1])
C0023671 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C1273390 (UMLS CUI [7,2])
C0006826 (UMLS CUI [7,3])
Allogeneic bone marrow transplantation
Item
7. history of prior allogeneic bone marrow transplant
boolean
C0149615 (UMLS CUI [1])
Hepatitis B | Hepatitis C | Hepatitis B surface antigen positive
Item
8. evidence of active hepatitis b or c infection or positivity for hepatitis-b surface antigen
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
Immediate hypersensitivity Zevalin Component | Anaphylaxis Zevalin Component | Human anti-mouse antibody Present
Item
9. known type 1 hypersensitivity or anaphylactic proteins to any component of the zevalin therapy or a history or presence of human anti-mouse antibodies (hama)
boolean
C0020523 (UMLS CUI [1,1])
C0919274 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0002792 (UMLS CUI [2,1])
C0919274 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C1291910 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods Absent
Item
10. a female patient who is pregnant or breast feeding and an adult of reproductive potential who is not employing an effective method of birth control during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Central nervous system lymphoma
Item
11. cns lymphoma
boolean
C0742472 (UMLS CUI [1])
Communicable Disease | Communicable Disease Suspected
Item
12. ongoing confirmed or suspected significant infection
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Radioimmunotherapy
Item
13. prior treatment with radioimmunotherapy
boolean
C0085101 (UMLS CUI [1])
Condition Preventing Nonmyeloablative stem cell transplantation
Item
14. other condition preventing participation in standard nst
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1831742 (UMLS CUI [1,3])
HLA Match Sibling Lacking
Item
15. no fully matched sibling donor
boolean
C4330149 (UMLS CUI [1,1])
C0037047 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
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