ID

23426

Description

Responsible Party: Elisabeth Schorb, Medical Trial Coordinator, University Hospital Freiburg ClinicalTrials.gov Identifier: NCT02531841 History of Changes Other Study ID Numbers: DRKS00005503 Study First Received: August 14, 2015 Last Updated: August 24, 2015 High-dose Chemotherapy and ASCT or Consolidating Conventional Chemotherapy in Primary CNS Lymphoma (MATRix) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02531841

Link

https://clinicaltrials.gov/ct2/show/NCT02531841

Keywords

Versions (1)
  1. 7/4/17 7/4/17 -
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July 4, 2017

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License

Creative Commons BY 4.0
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Eligibility Primary CNS Lymphoma DRKS00005503 NCT02531841 DRKS00005503

English

Eligibility Primary CNS Lymphoma NCT02531841 DRKS00005503

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Immunocompetent patients with newly-diagnosed primary central nervous system B-cell lymphoma
Description

Primary CNS Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0280803
2. Age 18-65 years irrespective of ECOG or 66-70 years (with ECOG Performance Status ≤2)
Description

Age, ECOG Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1520224
3. Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist.
Description

B-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0079731
4. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy
Description

Diagnostic Sample

Data type

boolean

Alias
UMLS CUI [1]
C0370003
5. Disease exclusively located in the CNS
Description

Disease Site

Data type

boolean

Alias
UMLS CUI [1]
C0449685
6. At least one measurable lesion
Description

Measurable Lesion

Data type

boolean

Alias
UMLS CUI [1]
C1513041
7. Previously untreated patients (previous or ongoing steroid treatment admitted)
Description

Untreated Disease

Data type

boolean

Alias
UMLS CUI [1]
C0332155
8. Sexually active patients of childbearing potential who agree to take adequate contraceptive measures during study participation
Description

Contraceptive Methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
9. Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
ADDITIONAL RANDOMIZATION CRITERIA: 1. Sufficient stem cell harvest (≥ 5 x 106 CD34+ cells/kg of body weight)
Description

Stem cell harvest

Data type

boolean

Alias
UMLS CUI [1]
C0411265
ADDITIONAL RANDOMIZATION CRITERIA: 2. Complete remission, unconfirmed complete remission or partial remission
Description

Remission

Data type

boolean

Alias
UMLS CUI [1]
C0544452
ADDITIONAL RANDOMIZATION CRITERIA: 3. Central pathology results confirming local results
Description

Confirmation

Data type

boolean

Alias
UMLS CUI [1]
C0750484
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
1. Congenital or acquired immunodeficiency
Description

Immunodeficiency

Data type

boolean

Alias
UMLS CUI [1]
C0021051
2. Systemic lymphoma manifestation (outside the CNS)
Description

Systemic Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0205373
3. Isolated ocular lymphoma without manifestation in the brain parenchyma or spinal cord
Description

Ocular lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0730306
4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other kinds of cancer without evidence of disease for at least 5 years
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
5. Previous Non-Hodgkin lymphoma at any time
Description

Non-Hodgkin lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0024305
6. Inadequate bone marrow (platelet count decreased ≥CTC grade 1, anemia ≥CTC grade 1, neutrophil count decreased ≥CTC grade 1), renal (creatinine clearance <60 ml/min), cardiac (ejection fraction decreased ≥CTC grade 2), or hepatic function (blood bilirubin increased ≥CTC grade 2, alanine aminotransferase increased ≥CTC grade 2, aspartate aminotransferase increased ≥CTC grade 2 or gamma-GT increased ≥CTC grade 2)
Description

Health Status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
7. HBsAg, anti-HBc or HCV positivity
Description

HBsAg, anti-HBc or HCV positivity

Data type

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0312631
UMLS CUI [3]
C0220847
8. HIV infection, previous organ transplantation or other clinical evident form of immunodeficiency
Description

HIV, Organ Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0029216
9. Concurrent treatment with other experimental drugs or participation in a clinical trial within the last thirty days before the start of this study
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
10. Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
Description

Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
11. Severe non-compensated pulmonary disease (IVC <55%, DLCO <40%)
Description

Pulmonary Disease

Data type

boolean

Alias
UMLS CUI [1]
C0024115
12. Third space fluid accumulation >500 ml
Description

Fluid accumulation

Data type

boolean

Alias
UMLS CUI [1]
C0333229
13. Hypersensitivity to study treatment or any component of the formulation
Description

Hypersensitivity to study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
14. Taking any medications likely to cause interactions with the study medication
Description

Drug interactions

Data type

boolean

Alias
UMLS CUI [1]
C0687133
15. Known or persistent abuse of medication, drugs or alcohol
Description

Substance Use Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
16. Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative
Description

Understanding Ability

Data type

boolean

Alias
UMLS CUI [1]
C0582778
17. Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator
Description

Relationship

Data type

boolean

Alias
UMLS CUI [1]
C0439849
18. Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
19. Concurrent (or planned) pregnancy or lactation
Description

Gynaecological Status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
20. Fertile patients refusing to use safe contraceptive methods during the study
Description

Refusing to Use Contraceptive Methods

Data type

boolean

Alias
UMLS CUI [1,1]
C1705116
UMLS CUI [1,2]
C0700589
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Similar models

Eligibility Primary CNS Lymphoma NCT02531841 DRKS00005503

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Primary CNS Lymphoma
Item
1. Immunocompetent patients with newly-diagnosed primary central nervous system B-cell lymphoma
boolean
C0280803 (UMLS CUI [1])
Age, ECOG Performance Status
Item
2. Age 18-65 years irrespective of ECOG or 66-70 years (with ECOG Performance Status ≤2)
boolean
C0001779 (UMLS CUI [1])
C1520224 (UMLS CUI [2])
B-cell lymphoma
Item
3. Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist.
boolean
C0079731 (UMLS CUI [1])
Diagnostic Sample
Item
4. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy
boolean
C0370003 (UMLS CUI [1])
Disease Site
Item
5. Disease exclusively located in the CNS
boolean
C0449685 (UMLS CUI [1])
Measurable Lesion
Item
6. At least one measurable lesion
boolean
C1513041 (UMLS CUI [1])
Untreated Disease
Item
7. Previously untreated patients (previous or ongoing steroid treatment admitted)
boolean
C0332155 (UMLS CUI [1])
Contraceptive Methods
Item
8. Sexually active patients of childbearing potential who agree to take adequate contraceptive measures during study participation
boolean
C0700589 (UMLS CUI [1])
Informed Consent
Item
9. Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease
boolean
C0021430 (UMLS CUI [1])
Stem cell harvest
Item
ADDITIONAL RANDOMIZATION CRITERIA: 1. Sufficient stem cell harvest (≥ 5 x 106 CD34+ cells/kg of body weight)
boolean
C0411265 (UMLS CUI [1])
Remission
Item
ADDITIONAL RANDOMIZATION CRITERIA: 2. Complete remission, unconfirmed complete remission or partial remission
boolean
C0544452 (UMLS CUI [1])
Confirmation
Item
ADDITIONAL RANDOMIZATION CRITERIA: 3. Central pathology results confirming local results
boolean
C0750484 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
0. Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Immunodeficiency
Item
1. Congenital or acquired immunodeficiency
boolean
C0021051 (UMLS CUI [1])
Systemic Lymphoma
Item
2. Systemic lymphoma manifestation (outside the CNS)
boolean
C0024299 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Ocular lymphoma
Item
3. Isolated ocular lymphoma without manifestation in the brain parenchyma or spinal cord
boolean
C0730306 (UMLS CUI [1])
Malignant Neoplasms
Item
4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other kinds of cancer without evidence of disease for at least 5 years
boolean
C0006826 (UMLS CUI [1])
Non-Hodgkin lymphoma
Item
5. Previous Non-Hodgkin lymphoma at any time
boolean
C0024305 (UMLS CUI [1])
Health Status
Item
6. Inadequate bone marrow (platelet count decreased ≥CTC grade 1, anemia ≥CTC grade 1, neutrophil count decreased ≥CTC grade 1), renal (creatinine clearance <60 ml/min), cardiac (ejection fraction decreased ≥CTC grade 2), or hepatic function (blood bilirubin increased ≥CTC grade 2, alanine aminotransferase increased ≥CTC grade 2, aspartate aminotransferase increased ≥CTC grade 2 or gamma-GT increased ≥CTC grade 2)
boolean
C0018759 (UMLS CUI [1])
HBsAg, anti-HBc or HCV positivity
Item
7. HBsAg, anti-HBc or HCV positivity
boolean
C0019168 (UMLS CUI [1])
C0312631 (UMLS CUI [2])
C0220847 (UMLS CUI [3])
HIV, Organ Transplantation
Item
8. HIV infection, previous organ transplantation or other clinical evident form of immunodeficiency
boolean
C0019682 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
Study Participation Status
Item
9. Concurrent treatment with other experimental drugs or participation in a clinical trial within the last thirty days before the start of this study
boolean
C2348568 (UMLS CUI [1])
Heart Disease
Item
10. Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
boolean
C0018799 (UMLS CUI [1])
Pulmonary Disease
Item
11. Severe non-compensated pulmonary disease (IVC <55%, DLCO <40%)
boolean
C0024115 (UMLS CUI [1])
Fluid accumulation
Item
12. Third space fluid accumulation >500 ml
boolean
C0333229 (UMLS CUI [1])
Hypersensitivity to study drug
Item
13. Hypersensitivity to study treatment or any component of the formulation
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Drug interactions
Item
14. Taking any medications likely to cause interactions with the study medication
boolean
C0687133 (UMLS CUI [1])
Substance Use Disorder
Item
15. Known or persistent abuse of medication, drugs or alcohol
boolean
C0038586 (UMLS CUI [1])
Understanding Ability
Item
16. Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative
boolean
C0582778 (UMLS CUI [1])
Relationship
Item
17. Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator
boolean
C0439849 (UMLS CUI [1])
Compliance
Item
18. Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C1321605 (UMLS CUI [1])
Gynaecological Status
Item
19. Concurrent (or planned) pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Refusing to Use Contraceptive Methods
Item
20. Fertile patients refusing to use safe contraceptive methods during the study
boolean
C1705116 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
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