ID

45392

Description

Principal Investigator: Richard Weinshilboum, MD, Mayo Clinic MeSH: Leukemia, Lymphoid https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000621 The ECOG 2997 trial was a randomized controlled trial for patients with previously untreated CLL comparing fludarabine monotherapy to the combination of fludarabine and cyclophosphamide. The initial clinical findings of this study were published in the Journal of Clinical Oncology in 2007 (JCO 25:793-8). Additional laboratory studies have also published (JCO 25:799-804).

Link

dbGaP study = phs000621

Keywords

Versions (1)
  1. 11/15/22 11/15/22 - Simon Heim
Copyright Holder

Richard Weinshilboum, MD, Mayo Clinic

Uploaded on

November 15, 2022

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License

Creative Commons BY 4.0
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dbGaP phs000621 Genome Wide Association Studies in ECOG 2997 Trial

English

Eligibility Criteria

5 forms  
Inclusion and exclusion criteria
Description

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
DISEASE CHARACTERISTICS:
Description

DISEASE CHARACTERISTICS:

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1521970
Diagnosis of chronic lymphocytic leukemia (CLL) of any stage as defined by the following:
Description

Diagnosis of chronic lymphocytic leukemia (CLL) of any stage as defined by the following:

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0023434
Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 within 14 days prior to study
Description

Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 within 14 days prior to study

Data type

boolean

Alias
UMLS CUI [1,1]
C5401001
UMLS CUI [1,2]
C3544087
UMLS CUI [1,3]
C4071839
UMLS CUI [1,4]
C5421123
Lymphocytes must be small to moderate size with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
Description

Lymphocytes must be small to moderate size with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically

Data type

boolean

Alias
UMLS CUI [1,1]
C1550651
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C0229614
UMLS CUI [1,5]
C0221277
UMLS CUI [1,6]
C0229613
Phenotypically characterized as B-CLL
Description

Phenotypically characterized as B-CLL

Data type

boolean

Alias
UMLS CUI [1,1]
C0031437
UMLS CUI [1,2]
C1880022
UMLS CUI [1,3]
C0861888
Must have one of the following characteristics indicating need for chemotherapy:
Description

Must have one of the following characteristics indicating need for chemotherapy:

Data type

boolean

Alias
UMLS CUI [1,1]
C0599878
UMLS CUI [1,2]
C0686904
UMLS CUI [1,3]
C3665472
Progressive marrow failure (hemoglobin less than 10 g/dL and/or platelet count less than 100,000/mm^3)
Description

Progressive marrow failure (hemoglobin less than 10 g/dL and/or platelet count less than 100,000/mm^3)

Data type

boolean

Alias
UMLS CUI [1,1]
C4228360
UMLS CUI [1,2]
C0032181
UMLS CUI [1,3]
C0518015
Progressive lymphocytosis with an increase of more than 50% over a 2 month period or anticipated doubling time of less than 6 months
Description

Progressive lymphocytosis with an increase of more than 50% over a 2 month period or anticipated doubling time of less than 6 months

Data type

boolean

Alias
UMLS CUI [1,1]
C0205329
UMLS CUI [1,2]
C0024282
Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly
Description

Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly

Data type

boolean

Alias
UMLS CUI [1,1]
C0522501
UMLS CUI [1,2]
C1335499
UMLS CUI [1,3]
C0038002
Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy
Description

Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0522501
UMLS CUI [1,2]
C0024204
UMLS CUI [1,3]
C1704332
UMLS CUI [1,4]
C0497156
UMLS CUI [1,5]
C1335499
At least 10% weight loss within 6 months of study
Description

At least 10% weight loss within 6 months of study

Data type

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C3828652
Extreme fatigue
Description

Extreme fatigue

Data type

boolean

Alias
UMLS CUI [1,1]
C0205403
UMLS CUI [1,2]
C0015672
Fevers greater than 100.5 degrees F for 2 weeks without evidence of infection
Description

Fevers greater than 100.5 degrees F for 2 weeks without evidence of infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C1442457
UMLS CUI [1,4]
C0332125
UMLS CUI [1,5]
C3714514
Night sweats without evidence of infection
Description

Night sweats without evidence of infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0028081
UMLS CUI [1,2]
C0332125
UMLS CUI [1,3]
C3714514
No autoimmune anemia or autoimmune thrombocytopenia
Description

No autoimmune anemia or autoimmune thrombocytopenia

Data type

boolean

Alias
UMLS CUI [1,1]
C1549444
UMLS CUI [1,2]
C0002880
UMLS CUI [1,3]
C0242584
PATIENT CHARACTERISTICS:
Description

PATIENT CHARACTERISTICS:

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1521970
Age:
Description

Age:

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
18 and over
Description

18 and over

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
Performance status:
Description

Performance status:

Data type

boolean

Alias
UMLS CUI [1,1]
C1518965
ECOG 0-2
Description

ECOG 0-2

Data type

boolean

Alias
UMLS CUI [1,1]
C1520224
Life expectancy:
Description

Life expectancy:

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
Not specified
Description

Not specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0205370
Hematopoietic:
Description

Hematopoietic:

Data type

boolean

Alias
UMLS CUI [1,1]
C0229601
See Disease Characteristics
Description

See Disease Characteristics

Data type

boolean

Alias
UMLS CUI [1,1]
C0599878
Hepatic:
Description

Hepatic:

Data type

boolean

Alias
UMLS CUI [1,1]
C0205054
Bilirubin no greater than 2 mg/dL unless secondary to tumor
Description

Bilirubin no greater than 2 mg/dL unless secondary to tumor

Data type

boolean

Alias
UMLS CUI [1,1]
C0201913
Renal:
Description

Renal:

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
Creatinine no greater than 2.0 mg/dL
Description

Creatinine no greater than 2.0 mg/dL

Data type

boolean

Alias
UMLS CUI [1,1]
C0201976
Creatinine clearance at least 40 mL/min if creatinine is greater than 1.5 mg/dL
Description

Creatinine clearance at least 40 mL/min if creatinine is greater than 1.5 mg/dL

Data type

boolean

Alias
UMLS CUI [1,1]
C0373595
Other:
Description

Other:

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
No other prior or concurrent malignancy within the past 2 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
Description

No other prior or concurrent malignancy within the past 2 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0205420
UMLS CUI [1,4]
C0006826
UMLS CUI [1,5]
C0332300
UMLS CUI [1,6]
C0007117
UMLS CUI [1,7]
C0851140
No active infection requiring oral or intravenous antibiotics
Description

No active infection requiring oral or intravenous antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0205177
UMLS CUI [1,3]
C0009450
UMLS CUI [1,4]
C1514873
UMLS CUI [1,5]
C0003232
UMLS CUI [1,6]
C0442027
UMLS CUI [1,7]
C0348016
Not pregnant or nursing
Description

Not pregnant or nursing

Data type

boolean

Alias
UMLS CUI [1,1]
C1272460
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0006147
Fertile patients must use effective contraception
Description

Fertile patients must use effective contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
PRIOR CONCURRENT THERAPY:
Description

PRIOR CONCURRENT THERAPY:

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
Biologic therapy:
Description

Biologic therapy:

Data type

boolean

Alias
UMLS CUI [1,1]
C0005527
Not specified
Description

Not specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0205370
Chemotherapy:
Description

Chemotherapy:

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
No prior cytotoxic chemotherapy
Description

No prior cytotoxic chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C1514457
UMLS CUI [1,3]
C0677881
Endocrine therapy:
Description

Endocrine therapy:

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
No prior steroid treatment for CLL
Description

No prior steroid treatment for CLL

Data type

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0149783
UMLS CUI [1,4]
C0023434
Radiotherapy:
Description

Radiotherapy:

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
Not specified
Description

Not specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0205370
Surgery:
Description

Surgery:

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
Not specified
Description

Not specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0205370
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Similar models

Eligibility Criteria

5 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
DISEASE CHARACTERISTICS:
Item
DISEASE CHARACTERISTICS:
boolean
C0012634 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
Diagnosis of chronic lymphocytic leukemia (CLL) of any stage as defined by the following:
Item
Diagnosis of chronic lymphocytic leukemia (CLL) of any stage as defined by the following:
boolean
C0011900 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 within 14 days prior to study
Item
Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 within 14 days prior to study
boolean
C5401001 (UMLS CUI [1,1])
C3544087 (UMLS CUI [1,2])
C4071839 (UMLS CUI [1,3])
C5421123 (UMLS CUI [1,4])
Lymphocytes must be small to moderate size with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
Item
Lymphocytes must be small to moderate size with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
boolean
C1550651 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0229614 (UMLS CUI [1,4])
C0221277 (UMLS CUI [1,5])
C0229613 (UMLS CUI [1,6])
Phenotypically characterized as B-CLL
Item
Phenotypically characterized as B-CLL
boolean
C0031437 (UMLS CUI [1,1])
C1880022 (UMLS CUI [1,2])
C0861888 (UMLS CUI [1,3])
Must have one of the following characteristics indicating need for chemotherapy:
Item
Must have one of the following characteristics indicating need for chemotherapy:
boolean
C0599878 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C3665472 (UMLS CUI [1,3])
Progressive marrow failure (hemoglobin less than 10 g/dL and/or platelet count less than 100,000/mm^3)
Item
Progressive marrow failure (hemoglobin less than 10 g/dL and/or platelet count less than 100,000/mm^3)
boolean
C4228360 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
C0518015 (UMLS CUI [1,3])
Progressive lymphocytosis with an increase of more than 50% over a 2 month period or anticipated doubling time of less than 6 months
Item
Progressive lymphocytosis with an increase of more than 50% over a 2 month period or anticipated doubling time of less than 6 months
boolean
C0205329 (UMLS CUI [1,1])
C0024282 (UMLS CUI [1,2])
Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly
Item
Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly
boolean
C0522501 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
C0038002 (UMLS CUI [1,3])
Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy
Item
Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy
boolean
C0522501 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C1704332 (UMLS CUI [1,3])
C0497156 (UMLS CUI [1,4])
C1335499 (UMLS CUI [1,5])
At least 10% weight loss within 6 months of study
Item
At least 10% weight loss within 6 months of study
boolean
C1262477 (UMLS CUI [1,1])
C3828652 (UMLS CUI [1,2])
Extreme fatigue
Item
Extreme fatigue
boolean
C0205403 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
Fevers greater than 100.5 degrees F for 2 weeks without evidence of infection
Item
Fevers greater than 100.5 degrees F for 2 weeks without evidence of infection
boolean
C0015967 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1442457 (UMLS CUI [1,3])
C0332125 (UMLS CUI [1,4])
C3714514 (UMLS CUI [1,5])
Night sweats without evidence of infection
Item
Night sweats without evidence of infection
boolean
C0028081 (UMLS CUI [1,1])
C0332125 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
No autoimmune anemia or autoimmune thrombocytopenia
Item
No autoimmune anemia or autoimmune thrombocytopenia
boolean
C1549444 (UMLS CUI [1,1])
C0002880 (UMLS CUI [1,2])
C0242584 (UMLS CUI [1,3])
PATIENT CHARACTERISTICS:
Item
PATIENT CHARACTERISTICS:
boolean
C0030705 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
Age:
Item
Age:
boolean
C0001779 (UMLS CUI [1,1])
18 and over
Item
18 and over
boolean
C0001779 (UMLS CUI [1,1])
Performance status:
Item
Performance status:
boolean
C1518965 (UMLS CUI [1,1])
ECOG 0-2
Item
ECOG 0-2
boolean
C1520224 (UMLS CUI [1,1])
Life expectancy:
Item
Life expectancy:
boolean
C0023671 (UMLS CUI [1,1])
Not specified
Item
Not specified
boolean
C0205370 (UMLS CUI [1,1])
Hematopoietic:
Item
Hematopoietic:
boolean
C0229601 (UMLS CUI [1,1])
See Disease Characteristics
Item
See Disease Characteristics
boolean
C0599878 (UMLS CUI [1,1])
Hepatic:
Item
Hepatic:
boolean
C0205054 (UMLS CUI [1,1])
Bilirubin no greater than 2 mg/dL unless secondary to tumor
Item
Bilirubin no greater than 2 mg/dL unless secondary to tumor
boolean
C0201913 (UMLS CUI [1,1])
Renal:
Item
Renal:
boolean
C0232804 (UMLS CUI [1,1])
Creatinine no greater than 2.0 mg/dL
Item
Creatinine no greater than 2.0 mg/dL
boolean
C0201976 (UMLS CUI [1,1])
Creatinine clearance at least 40 mL/min if creatinine is greater than 1.5 mg/dL
Item
Creatinine clearance at least 40 mL/min if creatinine is greater than 1.5 mg/dL
boolean
C0373595 (UMLS CUI [1,1])
Other:
Item
Other:
boolean
C0205394 (UMLS CUI [1,1])
No other prior or concurrent malignancy within the past 2 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
Item
No other prior or concurrent malignancy within the past 2 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
boolean
C1298908 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C0332300 (UMLS CUI [1,5])
C0007117 (UMLS CUI [1,6])
C0851140 (UMLS CUI [1,7])
No active infection requiring oral or intravenous antibiotics
Item
No active infection requiring oral or intravenous antibiotics
boolean
C1298908 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
C0003232 (UMLS CUI [1,5])
C0442027 (UMLS CUI [1,6])
C0348016 (UMLS CUI [1,7])
Not pregnant or nursing
Item
Not pregnant or nursing
boolean
C1272460 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,3])
Fertile patients must use effective contraception
Item
Fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
PRIOR CONCURRENT THERAPY:
Item
PRIOR CONCURRENT THERAPY:
boolean
C1514463 (UMLS CUI [1,1])
Biologic therapy:
Item
Biologic therapy:
boolean
C0005527 (UMLS CUI [1,1])
Not specified
Item
Not specified
boolean
C0205370 (UMLS CUI [1,1])
Chemotherapy:
Item
Chemotherapy:
boolean
C0392920 (UMLS CUI [1,1])
No prior cytotoxic chemotherapy
Item
No prior cytotoxic chemotherapy
boolean
C1298908 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0677881 (UMLS CUI [1,3])
Endocrine therapy:
Item
Endocrine therapy:
boolean
C0279025 (UMLS CUI [1,1])
No prior steroid treatment for CLL
Item
No prior steroid treatment for CLL
boolean
C1298908 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0149783 (UMLS CUI [1,3])
C0023434 (UMLS CUI [1,4])
Radiotherapy:
Item
Radiotherapy:
boolean
C1522449 (UMLS CUI [1,1])
Not specified
Item
Not specified
boolean
C0205370 (UMLS CUI [1,1])
Surgery:
Item
Surgery:
boolean
C0543467 (UMLS CUI [1,1])
Not specified
Item
Not specified
boolean
C0205370 (UMLS CUI [1,1])
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