ID

42213

Description

Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia see http://clinicaltrials.gov/ct2/show/record/NCT00006045

Link

http://clinicaltrials.gov/ct2/show/record/NCT00006045

Keywords

Versions (5)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 3/25/14 3/25/14 - Martin Dugas
  3. 4/11/14 4/11/14 - Julian Varghese
  4. 4/11/14 4/11/14 - Julian Varghese
  5. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00006045 AML

English

Eligibility AML NCT00006045

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility AML NCT00006045
Disease Characteristics
Description

Disease Characteristics

Alias
UMLS CUI-1
C1705348
Histologically proven acute myelogenous leukemia (AML) that may have been primary AML, secondary AML, or preceded by hematologic disorder
Description

AML

Data type

boolean

Alias
UMLS CUI-1
C0023467
All FAB subtypes except M3 Must meet one of the following three criteria: - First relapse within 1 year after documentation of a previous complete remission (CR) achieved by chemotherapy - Refractory to prior chemotherapy comprised of a minimum of 1 induction course, including cytarabine at a minimum of 500 mg/m2 (e.g., 100 mg/m2/day for 5 days) plus an anthracycline - No high dose cytarabine (no cumulative dose greater than 3 g/m2)
Description

except M3

Data type

boolean

First relapse from a previous CR with subsequent autologous bone marrow transplantation (BMT), only if all of the following criteria are met: - First BMT At least 100 days but less than 1 year posttransplantation - At least 25% cellularity of the bone marrow - Previous BMT included full hematopoietic recovery, defined by all of the following: -- Hemoglobin at least 10 g/dL (without transfusion) -- Platelet count at least 100,000/mm3 (without transfusion) -- Absolute neutrophil count at least 1,500/mm3
Description

First relapse

Data type

boolean

Alias
UMLS CUI-1
C0699753
UMLS CUI-2
C1287267
UMLS CUI-3
C0948762
UMLS CUI-4
C0019046
No transplantation candidates
Description

No BMT

Data type

boolean

Alias
UMLS CUI-1
C1518422
UMLS CUI-2
C0005961
Bone marrow blasts (leukemic cells) greater than 10% No chronic myelogenous leukemia in blast crisis
Description

Bone marrow blasts

Data type

boolean

Alias
UMLS CUI-1
C0368761
No active CNS leukemia
Description

No CNS leukemia

Data type

boolean

Alias
UMLS CUI-1
C1518422
UMLS CUI-2
C1332884
Patient Characteristics
Description

Patient Characteristics

Alias
UMLS CUI-1
C0815172
Age: 18 and over
Description

Age

Data type

boolean

Alias
UMLS CUI-1
C0001779
Karnofsky 50-100%
Description

Karnofsky performance status

Data type

boolean

Alias
UMLS CUI-1
C0206065
Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration)
Description

Bilirubin

Data type

boolean

Alias
UMLS CUI-1
C1278039
SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML) C1522609
Description

SGOT, SGPT

Data type

boolean

Alias
UMLS CUI-1
C0201899
UMLS CUI-2
C0201836
Creatinine less than 2.0 mg/dL (unless related to AML)
Description

Serum creatinine

Data type

boolean

Alias
UMLS CUI-1
C0201976
Left ventricular function normal No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No electrocardiogram evidence of active ischemia
Description

No major cardiovascular diseases

Data type

boolean

Alias
UMLS CUI-1
C1518422
UMLS CUI-2
C0007222
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study negation
Description

Not pregnant or nursing

Data type

boolean

Alias
UMLS CUI-2
C0549206
UMLS CUI-3
C0006147
HIV negative
Description

HIV negative

Data type

boolean

Alias
UMLS CUI-1
C0481430
No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction
Description

No other major disease

Data type

boolean

Prior concurrent therapy
Description

Prior concurrent therapy

Alias
UMLS CUI-1
C1514463
At least 30 days since prior experimental biologic therapy (e.g., interleukin-2) No concurrent biologic therapy, including bone marrow transplantation
Description

Biologic therapy

Data type

boolean

Alias
UMLS CUI-1
C0005527
For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count Hydroxyurea must be discontinued prior to study For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above No other concurrent chemotherapy
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI-1
C0392920
No concurrent radiotherapy
Description

Radiotherapy

Data type

boolean

Alias
UMLS CUI-1
C0034619
No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed
Description

Other

Data type

boolean

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Similar models

Eligibility AML NCT00006045

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility AML NCT00006045
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Disease Characteristics
C1705348 (UMLS CUI-1)
AML
Item
Histologically proven acute myelogenous leukemia (AML) that may have been primary AML, secondary AML, or preceded by hematologic disorder
boolean
C0023467 (UMLS CUI-1)
except M3
Item
All FAB subtypes except M3 Must meet one of the following three criteria: - First relapse within 1 year after documentation of a previous complete remission (CR) achieved by chemotherapy - Refractory to prior chemotherapy comprised of a minimum of 1 induction course, including cytarabine at a minimum of 500 mg/m2 (e.g., 100 mg/m2/day for 5 days) plus an anthracycline - No high dose cytarabine (no cumulative dose greater than 3 g/m2)
boolean
First relapse
Item
First relapse from a previous CR with subsequent autologous bone marrow transplantation (BMT), only if all of the following criteria are met: - First BMT At least 100 days but less than 1 year posttransplantation - At least 25% cellularity of the bone marrow - Previous BMT included full hematopoietic recovery, defined by all of the following: -- Hemoglobin at least 10 g/dL (without transfusion) -- Platelet count at least 100,000/mm3 (without transfusion) -- Absolute neutrophil count at least 1,500/mm3
boolean
C0699753 (UMLS CUI-1)
C1287267 (UMLS CUI-2)
C0948762 (UMLS CUI-3)
C0019046 (UMLS CUI-4)
No BMT
Item
No transplantation candidates
boolean
C1518422 (UMLS CUI-1)
C0005961 (UMLS CUI-2)
Bone marrow blasts
Item
Bone marrow blasts (leukemic cells) greater than 10% No chronic myelogenous leukemia in blast crisis
boolean
C0368761 (UMLS CUI-1)
No CNS leukemia
Item
No active CNS leukemia
boolean
C1518422 (UMLS CUI-1)
C1332884 (UMLS CUI-2)
Item Group
Patient Characteristics
C0815172 (UMLS CUI-1)
Age
Item
Age: 18 and over
boolean
C0001779 (UMLS CUI-1)
Karnofsky performance status
Item
Karnofsky 50-100%
boolean
C0206065 (UMLS CUI-1)
Bilirubin
Item
Bilirubin less than 2.0 mg/dL (unless related to Gilbert's disease or due to leukemic infiltration)
boolean
C1278039 (UMLS CUI-1)
SGOT, SGPT
Item
SGOT or SGPT no greater than 4 times upper limit of normal (unless related to AML) C1522609
boolean
C0201899 (UMLS CUI-1)
C0201836 (UMLS CUI-2)
Serum creatinine
Item
Creatinine less than 2.0 mg/dL (unless related to AML)
boolean
C0201976 (UMLS CUI-1)
No major cardiovascular diseases
Item
Left ventricular function normal No unstable cardiac arrhythmias, unstable angina pectoris, or myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease No electrocardiogram evidence of active ischemia
boolean
C1518422 (UMLS CUI-1)
C0007222 (UMLS CUI-2)
Not pregnant or nursing
Item
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study negation
boolean
C0549206 (UMLS CUI-2)
C0006147 (UMLS CUI-3)
HIV negative
Item
HIV negative
boolean
C0481430 (UMLS CUI-1)
No other major disease
Item
No other active malignancy requiring therapy No active serious infection that is uncontrolled by antimicrobial therapy Medically stable No significant organ dysfunction
boolean
Item Group
Prior concurrent therapy
C1514463 (UMLS CUI-1)
Biologic therapy
Item
At least 30 days since prior experimental biologic therapy (e.g., interleukin-2) No concurrent biologic therapy, including bone marrow transplantation
boolean
C0005527 (UMLS CUI-1)
Chemotherapy
Item
For first relapse AML with recent or prior chemotherapy: Prior hydroxyurea given as a short course (up to 48 hours) allowed, if needed, to reduce the peripheral leukocyte count Hydroxyurea must be discontinued prior to study For refractory AML with recent or prior chemotherapy: Greater than 2 weeks since prior chemotherapy except hydroxyurea given as above No other concurrent chemotherapy
boolean
C0392920 (UMLS CUI-1)
Radiotherapy
Item
No concurrent radiotherapy
boolean
C0034619 (UMLS CUI-1)
Other
Item
No other concurrent experimental therapy Concurrent therapy for other preexisting diseases allowed
boolean
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