ID

29846

Description

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome

Link

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Keywords

Versions (1)
  1. 4/24/18 4/24/18 - Halim Ugurlu
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April 24, 2018

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GSK Study ID 104864-201 Inclusion-Exclusion Criteria and Telephone Randomisation

English

Inclusion-Exclusion Criteria and Telephone Randomisation

1 forms  
Identification Numbers
Description

Identification Numbers

Alias
UMLS CUI-1
C1300638
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Inclusion Criteria-Do not admit the patient to this study if any "No" box has been marked
Description

Inclusion Criteria-Do not admit the patient to this study if any "No" box has been marked

Alias
UMLS CUI-1
C1512693
Written informed consent (see Sample Informed Consent Form protocol Appendix E)
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
At least 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Diagnosis
Description

a)Diagnosis of myelodysplastic syndrome, subcategories of refractory anemia with excess of blasts, INT 2 or high risk (RAEB) as defined by Greenberg, et al, [4] (see protocol Appendix L), or refractory anemia with excess of blasts in transformation (RAEB-t) OR b)Diagnosis of AML which has evolved from a preceding phase of MDS defined as the presence of antecedent hematologic disorder existing for at least the past three months, AML and/or poor prognosis cytogenetics.

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0023467
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C3463824
Performance Status and life expectancy
Description

Performance status <= 2 (Zubrod-ECOG-WHO cale, protocol Appendix C) and life expectancy =>6 weeks.

Data type

boolean

Alias
UMLS CUI [1,1]
C1520224
UMLS CUI [1,2]
C0023671
Prior Chemotherapy
Description

Patients must not have received prior chemotherapy except low-dose ara-C, hydroxyurea, or intrathecal methotrexate for MDS or AML.

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C0010711
UMLS CUI [1,4]
C1707814
UMLS CUI [1,5]
C0025677
UMLS CUI [1,6]
C0677897
Recovery from all toxicities
Description

Recovery from all toxicities since last chemotherapy and/or biologic therapy, unless specific conditions discussed with medical monitor.

Data type

boolean

Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C2004454
Previous malignancies
Description

Patients with previous malignancies in CR for one year or greater.

Data type

boolean

Alias
UMLS CUI [1,1]
C2735088
UMLS CUI [1,2]
C0006826
Not being candidate for curative allogenic bone marrow transplant
Description

Patients must not be candidates for curative allogenic bone marrow transplant at the time of treatment, although it is recognized they may become candidates at a future time (i.e., a matched donor is found).

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0149615
Limited Laboratory Values
Description

Current laboratory values within the limits listed below unless agreed upon by the principal investigator and the medical monitor: - creatinine <= 1.5 mg/dL (133 micromol/l) - serum bilirubin <= 2.0 mg/dL (34 micromol/l) SGOT/SGPT <= 2 times the upper limit of normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0042295
Left ventricular ejection fraction
Description

Patients must have a left ventricular ejection fraction (LVEF) of at least 50%

Data type

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria-Do not admit the patient to this study if any "Yes" box has been marked
Description

Exclusion Criteria-Do not admit the patient to this study if any "Yes" box has been marked

Alias
UMLS CUI-1
C0680251
Eligibilty for curative allogenic bone marrow transplant
Description

Patients who are eligible for curative allogenic bone marrow transplant without additional treatment.

Data type

boolean

Alias
UMLS CUI [1,1]
C0149615
UMLS CUI [1,2]
C0013893
Patients with chromosomal abnormalities
Description

Patients with chromosomal abnormalities of t(15;17), t(8;21), or inv(16)

Data type

boolean

Alias
UMLS CUI [1,1]
C0008625
UMLS CUI [1,2]
C2348235
Patients with CMML
Description

Patients with CMML.

Data type

boolean

Alias
UMLS CUI [1]
C0023480
Less than 3 weeks since major surgery
Description

Less than 3 weeks since major surgery, except for placement of central line.

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0040223
Concomitant malignancies
Description

Concomitant malignancies with the exception of curatively treated basal cell carcinoma of the skin, carcinoma in situ of the cervix and previous malignancies in CR for less than one year.

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0007114
UMLS CUI [1,4]
C2216722
UMLS CUI [1,5]
C0242793
Concurrent severe medical problems unrelated to the malignancy
Description

Concurrent severe medical problems unrelated to the malignancy which would significantly limit the full compliance with the study or expose the patient to extreme risk.

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
Uncontrolled or severe cardiovascular disease
Description

Uncontrolled or severe cardiovascular disease including recent (< 3 months) myocardial infarction or congestive heart failure.

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0205082
Active infection
Description

Active infection

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0205177
History of (+) HIV
Description

Patients who have a history of (+) HIV.

Data type

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0262926
Patients who have (+) PPD with abnormal CXR
Description

Patients who have (+) PPD with abnormal CXR

Data type

boolean

Alias
UMLS CUI [1,1]
C0032739
UMLS CUI [1,2]
C2041426
UMLS CUI [1,3]
C0205161
Females of child-bearing potential, not practicing adequate contraception
Description

Females of child-bearing potential, not practicing adequate contraception. Females of child-bearing potential, premenopausal (less than 60 years of age), or not surgically sterilized must use effective contraception by barrier method contraception, an interuterine device (IUD) or use of birth control pill for 3 months prior to entry into the study and agree to continue to use it during the study and for at least 4 weeks after the end of study drug administration.

Data type

boolean

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0700589
Pregnancy or lactation.
Description

Pregnancy or lactation.

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Use of an investigational drug
Description

Use of an investigational drug (including a cytotoxic drug) within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0040223
Concurrent use of other chemotherapy
Description

Concurrent use of other chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C4060806
Any chemotherapy with topotecan or idarubicin
Description

Any chemotherapy with topotecan or idarubicin

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0146224
UMLS CUI [2]
C0020789
History of hypersensitivity to compounds chemically related to topotecan, ara-C, idarubicin or G-CSF.
Description

History of hypersensitivity to compounds chemically related to topotecan, ara-C, idarubicin or G-CSF.

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0146224
UMLS CUI [1,3]
C0733521
UMLS CUI [1,4]
C0020789
UMLS CUI [1,5]
C0079459
Patient known to be refractory to "platelet transfusions."
Description

Patient known to be refractory to "platelet transfusions."

Data type

boolean

Alias
UMLS CUI [1,1]
C0086818
UMLS CUI [1,2]
C0205269
Telephone Randomisation
Description

Telephone Randomisation

Alias
UMLS CUI-1
C0039457
UMLS CUI-2
C0034656
Has a randomized number been obtained for the patient using the centralized telephone number?
Description

Telephone Randomisation

Data type

boolean

Alias
UMLS CUI [1,1]
C0039457
UMLS CUI [1,2]
C0034656
If Yes to Telephone Randomisation
Description

If Yes to Telephone Randomisation

Alias
UMLS CUI-1
C0039457
UMLS CUI-2
C0034656
Randomization Number
Description

Please record the patient's randomization number

Data type

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0034656
Regimen
Description

Please indicate which regimen the patient is scheduled to receive below

Data type

text

Alias
UMLS CUI [1]
C0392920
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Similar models

Inclusion-Exclusion Criteria and Telephone Randomisation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Identification Numbers
C1300638 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Inclusion Criteria-Do not admit the patient to this study if any "No" box has been marked
C1512693 (UMLS CUI-1)
Written informed consent
Item
Written informed consent (see Sample Informed Consent Form protocol Appendix E)
boolean
C0021430 (UMLS CUI [1])
Age
Item
At least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Diagnosis
Item
Diagnosis
boolean
C0011900 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C3463824 (UMLS CUI [2,2])
Performance Status and life expectancy
Item
Performance Status and life expectancy
boolean
C1520224 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
Prior Chemotherapy
Item
Prior Chemotherapy
boolean
C1514457 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,3])
C1707814 (UMLS CUI [1,4])
C0025677 (UMLS CUI [1,5])
C0677897 (UMLS CUI [1,6])
Recovery from all toxicities
Item
Recovery from all toxicities
boolean
C0013221 (UMLS CUI [1,1])
C2004454 (UMLS CUI [1,2])
Previous malignancies
Item
Previous malignancies
boolean
C2735088 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Not being candidate for curative allogenic bone marrow transplant
Item
Not being candidate for curative allogenic bone marrow transplant
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0149615 (UMLS CUI [1,3])
Limited Laboratory Values
Item
Limited Laboratory Values
boolean
C0022877 (UMLS CUI [1,1])
C0042295 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
Left ventricular ejection fraction
boolean
C0428772 (UMLS CUI [1])
Item Group
Exclusion Criteria-Do not admit the patient to this study if any "Yes" box has been marked
C0680251 (UMLS CUI-1)
Eligibilty for curative allogenic bone marrow transplant
Item
Eligibilty for curative allogenic bone marrow transplant
boolean
C0149615 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
Patients with chromosomal abnormalities
Item
Patients with chromosomal abnormalities
boolean
C0008625 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Patients with CMML
Item
Patients with CMML
boolean
C0023480 (UMLS CUI [1])
Major surgery
Item
Less than 3 weeks since major surgery
boolean
C0679637 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Concomitant malignancies
Item
Concomitant malignancies
boolean
C0006826 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0007114 (UMLS CUI [1,3])
C2216722 (UMLS CUI [1,4])
C0242793 (UMLS CUI [1,5])
Concurrent severe medical problems unrelated to the malignancy
Item
Concurrent severe medical problems unrelated to the malignancy
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Uncontrolled or severe cardiovascular disease
Item
Uncontrolled or severe cardiovascular disease
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Active infection
Item
Active infection
boolean
C3714514 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
History of (+) HIV
Item
History of (+) HIV
boolean
C0019693 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Patients who have (+) PPD with abnormal CXR
Item
Patients who have (+) PPD with abnormal CXR
boolean
C0032739 (UMLS CUI [1,1])
C2041426 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Females of child-bearing potential, not practicing adequate contraception
Item
Females of child-bearing potential, not practicing adequate contraception
boolean
C1960468 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Pregnancy or lactation.
Item
Pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Use of an investigational drug
Item
Use of an investigational drug
boolean
C0013230 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Concurrent use of other chemotherapy
Item
Concurrent use of other chemotherapy
boolean
C0003392 (UMLS CUI [1,1])
C4060806 (UMLS CUI [1,2])
Any chemotherapy with topotecan or idarubicin
Item
Any chemotherapy with topotecan or idarubicin
boolean
C3665472 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0020789 (UMLS CUI [2])
History of hypersensitivity
Item
History of hypersensitivity to compounds chemically related to topotecan, ara-C, idarubicin or G-CSF.
boolean
C0020517 (UMLS CUI [1,1])
C0146224 (UMLS CUI [1,2])
C0733521 (UMLS CUI [1,3])
C0020789 (UMLS CUI [1,4])
C0079459 (UMLS CUI [1,5])
Patient known to be refractory to "platelet transfusions."
Item
Patient known to be refractory to "platelet transfusions."
boolean
C0086818 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Item Group
Telephone Randomisation
C0039457 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Telephone Randomisation
Item
Has a randomized number been obtained for the patient using the centralized telephone number?
boolean
C0039457 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item Group
If Yes to Telephone Randomisation
C0039457 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Randomization Number
Item
Randomization Number
text
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item
Regimen
text
C0392920 (UMLS CUI [1])
Regimen
Code List
Regimen
CL Item
Topotecan, ara-C G-CSF (TA)
CL Item
Idarubicin, ara-C G-CSF (AA)
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