ID

30423

Description

SCH 727965 in Patients With Mantle Cell Lymphoma or B-Cell Chronic Lymphocytic Leukemia (Study P04715); ODM derived from: https://clinicaltrials.gov/show/NCT00871546

Link

https://clinicaltrials.gov/show/NCT00871546

Keywords

Versions (1)
  1. 6/4/18 6/4/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 4, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma, Mantle-Cell NCT00871546

English

Eligibility Lymphoma, Mantle-Cell NCT00871546

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >=18 years, either sex, any race.
Description

Age | Race Any

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C1552551
eastern cooperative oncology group performance status of 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematologic, renal, and hepatic organ function and laboratory parameters.
Description

Hematologic function | Renal function | Liver function | Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C1254595
for subjects with mcl:
Description

Study Subject Mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0334634
diagnosis of mcl according to the world health organization (who) criteria.
Description

Mantle cell lymphoma WHO tumor classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0334634
UMLS CUI [1,2]
C1301142
received at least one prior chemotherapeutic regimen, but no more than two regimens including stem cell transplantation..
Description

Chemotherapy Regimen Quantity | Stem cell transplant

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C1504389
measurable or assessable disease by the revised response criteria for malignant lymphoma.
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
for subjects with b-cll
Description

Study Subject Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0023434
documented b-cll according to the national cancer institute working group (nci-wg) criteria.
Description

Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0023434
received at least one prior alkylating agent-based regimen and one fludarabine-
Description

Alkylating Agents | fludarabine | Therapeutic procedure Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0002073
UMLS CUI [2]
C0059985
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1265611
or pentostatin-containing regimen, but must not have received more than two prior regimens.
Description

Pentostatin | Prior Therapy Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0030896
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1265611
measurable or assessable disease by nci-wg criteria.
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known central nervous system involvement of mcl or b-cll.
Description

Central Nervous System Involvement Mantle cell lymphoma | Central Nervous System Involvement Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0334634
UMLS CUI [2,1]
C4050309
UMLS CUI [2,2]
C0023434
previous treatment with sch 727965 or other cyclin-dependent kinase inhibitors.
Description

SCH 727965 | Cyclin-Dependent Kinase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C2711996
UMLS CUI [2]
C1511576
for mcl, previous treatment with bortezomib.
Description

Bortezomib | Study Subject Mantle cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1176309
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0334634
for b-cll, previous treatment with alemtuzumab.
Description

Alemtuzumab | Study Subject Chronic Lymphocytic Leukemia

Data type

boolean

Alias
UMLS CUI [1]
C0383429
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0023434
known hiv infection.
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
known active hepatitis b or c.
Description

Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
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Similar models

Eligibility Lymphoma, Mantle-Cell NCT00871546

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Race Any
Item
age >=18 years, either sex, any race.
boolean
C0001779 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
ECOG performance status
Item
eastern cooperative oncology group performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Laboratory Results
Item
adequate hematologic, renal, and hepatic organ function and laboratory parameters.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C1254595 (UMLS CUI [4])
Study Subject Mantle cell lymphoma
Item
for subjects with mcl:
boolean
C0681850 (UMLS CUI [1,1])
C0334634 (UMLS CUI [1,2])
Mantle cell lymphoma WHO tumor classification
Item
diagnosis of mcl according to the world health organization (who) criteria.
boolean
C0334634 (UMLS CUI [1,1])
C1301142 (UMLS CUI [1,2])
Chemotherapy Regimen Quantity | Stem cell transplant
Item
received at least one prior chemotherapeutic regimen, but no more than two regimens including stem cell transplantation..
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2])
Measurable Disease | Evaluable Disease
Item
measurable or assessable disease by the revised response criteria for malignant lymphoma.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Study Subject Chronic Lymphocytic Leukemia
Item
for subjects with b-cll
boolean
C0681850 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Chronic Lymphocytic Leukemia
Item
documented b-cll according to the national cancer institute working group (nci-wg) criteria.
boolean
C0023434 (UMLS CUI [1])
Alkylating Agents | fludarabine | Therapeutic procedure Quantity
Item
received at least one prior alkylating agent-based regimen and one fludarabine-
boolean
C0002073 (UMLS CUI [1])
C0059985 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Pentostatin | Prior Therapy Quantity
Item
or pentostatin-containing regimen, but must not have received more than two prior regimens.
boolean
C0030896 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Measurable Disease | Evaluable Disease
Item
measurable or assessable disease by nci-wg criteria.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Central Nervous System Involvement Mantle cell lymphoma | Central Nervous System Involvement Chronic Lymphocytic Leukemia
Item
known central nervous system involvement of mcl or b-cll.
boolean
C4050309 (UMLS CUI [1,1])
C0334634 (UMLS CUI [1,2])
C4050309 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
SCH 727965 | Cyclin-Dependent Kinase Inhibitors
Item
previous treatment with sch 727965 or other cyclin-dependent kinase inhibitors.
boolean
C2711996 (UMLS CUI [1])
C1511576 (UMLS CUI [2])
Bortezomib | Study Subject Mantle cell lymphoma
Item
for mcl, previous treatment with bortezomib.
boolean
C1176309 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0334634 (UMLS CUI [2,2])
Alemtuzumab | Study Subject Chronic Lymphocytic Leukemia
Item
for b-cll, previous treatment with alemtuzumab.
boolean
C0383429 (UMLS CUI [1])
C0681850 (UMLS CUI [2,1])
C0023434 (UMLS CUI [2,2])
HIV Infection
Item
known hiv infection.
boolean
C0019693 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
known active hepatitis b or c.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
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