ID

13719

Descripción

Bendamustine in Acute Leukemia and MDS; ODM derived from: https://clinicaltrials.gov/show/NCT00790855

Link

https://clinicaltrials.gov/show/NCT00790855

Palabras clave

Versiones (1)
  1. 1/3/16 1/3/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

1 de marzo de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT00790855

Inglés

Eligibility Acute Myeloid Leukemia NCT00790855

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients will be 16 years of age or older.
Descripción

1. patients will be 16 years of age or older.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission (longer than 3 months). patients with poor-risk myelodysplasia (mds) [i.e. refractory anemia with excess blasts (raeb-1 or raeb-2) by world health organization (who) classification] and chronic myelomonocytic leukemia (cmml) are also candidates for this protocol. relapsed/refractory leukemias include acute myeloid leukemia (aml), acute lymphocytic leukemia (all), or chronic myelogenous leukemia (cml) in blastic phase.
Descripción

2. patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission (longer than 3 months). patients with poor-risk myelodysplasia (mds) [i.e. refractory anemia with excess blasts (raeb-1 or raeb-2) by world health organization (who) classification] and chronic myelomonocytic leukemia (cmml) are also candidates for this protocol. relapsed/refractory leukemias include acute myeloid leukemia (aml), acute lymphocytic leukemia (all), or chronic myelogenous leukemia (cml) in blastic phase.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C0023480
UMLS CUI [3]
C0023467
UMLS CUI [4]
C0023474
UMLS CUI [5]
C0023449
3. continued from #2: elderly patients with aml who are not eligible for frontline standard therapy, or who refuse to be treated with intensive chemotherapy, may be eligible. the phase ii portion of the study will enroll patients with aml, mds, and all. patients with cml and cmml will not participate in the phase ii portion of the study. patients who are being considered for stem cell transplant are also eligible for this protocol.
Descripción

3. continued from #2: elderly patients with aml who are not eligible for frontline standard therapy, or who refuse to be treated with intensive chemotherapy, may be eligible. the phase ii portion of the study will enroll patients with aml, mds, and all. patients with cml and cmml will not participate in the phase ii portion of the study. patients who are being considered for stem cell transplant are also eligible for this protocol.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
UMLS CUI [3]
C0023449
4. eastern cooperative oncology group (ecog) performance status of 0-3.
Descripción

4. eastern cooperative oncology group (ecog) performance status of 0-3.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
5. women of child-bearing potential (i.e., woman has not been naturally postmenopausal for at least 24 consecutive months or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [iud], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. sexually active men must also use acceptable contraceptive methods for the duration of time on study. men and women must maintain effective contraception until 4 weeks after the last dose of drug is administered.
Descripción

5. women of child-bearing potential (i.e., woman has not been naturally postmenopausal for at least 24 consecutive months or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [iud], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. sexually active men must also use acceptable contraceptive methods for the duration of time on study. men and women must maintain effective contraception until 4 weeks after the last dose of drug is administered.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1960468
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0032976
6. must be able and willing to give written informed consent.
Descripción

6. must be able and willing to give written informed consent.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
7. in the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents. if the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol. persistent clinically significant toxicities (any grade 2 or worse toxicities, non-hematologic or hematologic) from prior chemotherapy must not be greater than grade 1.
Descripción

7. in the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents. if the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol. persistent clinically significant toxicities (any grade 2 or worse toxicities, non-hematologic or hematologic) from prior chemotherapy must not be greater than grade 1.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0013221
8. patients must have the following clinical laboratory values unless considered due to leukemic organ involvement: 1) serum creatinine </= 2.0 mg/dl; 2) total bilirubin </= 1.5 times the upper limit of normal unless considered due to gilbert's syndrome; 3) alanine aminotransferase (alt), or aspartate aminotransferase (ast) </= 3 times the upper limit of normal unless considered due to organ leukemic involvement.
Descripción

8. patients must have the following clinical laboratory values unless considered due to leukemic organ involvement: 1) serum creatinine </= 2.0 mg/dl; 2) total bilirubin </= 1.5 times the upper limit of normal unless considered due to gilbert's syndrome; 3) alanine aminotransferase (alt), or aspartate aminotransferase (ast) </= 3 times the upper limit of normal unless considered due to organ leukemic involvement.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
9. patients with active central nervous system (cns) disease are included and will be treated concurrently with intrathecal therapy.
Descripción

9. patients with active central nervous system (cns) disease are included and will be treated concurrently with intrathecal therapy.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1332884
10. phase ii portion: all above criteria apply. after the phase i portion, patients eligibility will be for only 3 disease categories which will accrue in parallel: 1) aml, 2) mds, and 3) all.
Descripción

10. phase ii portion: all above criteria apply. after the phase i portion, patients eligibility will be for only 3 disease categories which will accrue in parallel: 1) aml, 2) mds, and 3) all.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
UMLS CUI [2]
C3463824
UMLS CUI [3]
C0023449
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled intercurrent illness including, but not limited to uncontrolled infection (i.e. persistent fever, clinical deterioration), acute congestive heart failure and exacerbation, cardiac arrhythmia, chronic liver disease, or psychiatric illness/social situations that would limit compliance with study requirements.
Descripción

1. uncontrolled intercurrent illness including, but not limited to uncontrolled infection (i.e. persistent fever, clinical deterioration), acute congestive heart failure and exacerbation, cardiac arrhythmia, chronic liver disease, or psychiatric illness/social situations that would limit compliance with study requirements.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
2. active heart disease including myocardial infarction within previous 3 months, unstable angina, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. patients with new york heart association (nyha) class 3 or 4 are excluded.
Descripción

2. active heart disease including myocardial infarction within previous 3 months, unstable angina, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. patients with new york heart association (nyha) class 3 or 4 are excluded.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
3. patients receiving any other standard or investigational treatment for their hematologic malignancy, except as permitted under inclusion #9 above.
Descripción

3. patients receiving any other standard or investigational treatment for their hematologic malignancy, except as permitted under inclusion #9 above.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2015819
4. pregnant or breast feeding females are excluded because the effects of bendamustine on a fetus or nursing child are unknown.
Descripción

4. pregnant or breast feeding females are excluded because the effects of bendamustine on a fetus or nursing child are unknown.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Acute Myeloid Leukemia NCT00790855

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. patients will be 16 years of age or older.
boolean
C0001779 (UMLS CUI [1])
MDS, CMML, AML, CML, ALL
Item
2. patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission (longer than 3 months). patients with poor-risk myelodysplasia (mds) [i.e. refractory anemia with excess blasts (raeb-1 or raeb-2) by world health organization (who) classification] and chronic myelomonocytic leukemia (cmml) are also candidates for this protocol. relapsed/refractory leukemias include acute myeloid leukemia (aml), acute lymphocytic leukemia (all), or chronic myelogenous leukemia (cml) in blastic phase.
boolean
C3463824 (UMLS CUI [1])
C0023480 (UMLS CUI [2])
C0023467 (UMLS CUI [3])
C0023474 (UMLS CUI [4])
C0023449 (UMLS CUI [5])
AML, MDS, ALL
Item
3. continued from #2: elderly patients with aml who are not eligible for frontline standard therapy, or who refuse to be treated with intensive chemotherapy, may be eligible. the phase ii portion of the study will enroll patients with aml, mds, and all. patients with cml and cmml will not participate in the phase ii portion of the study. patients who are being considered for stem cell transplant are also eligible for this protocol.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
C0023449 (UMLS CUI [3])
ECOG
Item
4. eastern cooperative oncology group (ecog) performance status of 0-3.
boolean
C1520224 (UMLS CUI [1])
pregnancy and contraception
Item
5. women of child-bearing potential (i.e., woman has not been naturally postmenopausal for at least 24 consecutive months or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [iud], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. sexually active men must also use acceptable contraceptive methods for the duration of time on study. men and women must maintain effective contraception until 4 weeks after the last dose of drug is administered.
boolean
C1960468 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0032976 (UMLS CUI [3])
written informed consent
Item
6. must be able and willing to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
prior therapy and toxicity
Item
7. in the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents. if the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol. persistent clinically significant toxicities (any grade 2 or worse toxicities, non-hematologic or hematologic) from prior chemotherapy must not be greater than grade 1.
boolean
C1514463 (UMLS CUI [1])
C0013221 (UMLS CUI [2])
laboratory values
Item
8. patients must have the following clinical laboratory values unless considered due to leukemic organ involvement: 1) serum creatinine </= 2.0 mg/dl; 2) total bilirubin </= 1.5 times the upper limit of normal unless considered due to gilbert's syndrome; 3) alanine aminotransferase (alt), or aspartate aminotransferase (ast) </= 3 times the upper limit of normal unless considered due to organ leukemic involvement.
boolean
C0201976 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
cns leukemia
Item
9. patients with active central nervous system (cns) disease are included and will be treated concurrently with intrathecal therapy.
boolean
C1332884 (UMLS CUI [1])
phase ii portion
Item
10. phase ii portion: all above criteria apply. after the phase i portion, patients eligibility will be for only 3 disease categories which will accrue in parallel: 1) aml, 2) mds, and 3) all.
boolean
C0023467 (UMLS CUI [1])
C3463824 (UMLS CUI [2])
C0023449 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
comorbidity
Item
1. uncontrolled intercurrent illness including, but not limited to uncontrolled infection (i.e. persistent fever, clinical deterioration), acute congestive heart failure and exacerbation, cardiac arrhythmia, chronic liver disease, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
heart disease
Item
2. active heart disease including myocardial infarction within previous 3 months, unstable angina, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. patients with new york heart association (nyha) class 3 or 4 are excluded.
boolean
C0018799 (UMLS CUI [1])
any other treatment
Item
3. patients receiving any other standard or investigational treatment for their hematologic malignancy, except as permitted under inclusion #9 above.
boolean
C2015819 (UMLS CUI [1])
pregancny or breastfeeding
Item
4. pregnant or breast feeding females are excluded because the effects of bendamustine on a fetus or nursing child are unknown.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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