ID

21515

Beschreibung

Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT00493454

Link

https://clinicaltrials.gov/show/NCT00493454

Stichworte

Versionen (1)
  1. 25.04.17 25.04.17 -
Hochgeladen am

25. April 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00493454

Englisch

Eligibility Lymphoma NCT00493454

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00493454
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. no anti-cancer therapy for three weeks (six weeks if rituximab, nitrosourea or mitomycin c) prior to study initiation, and fully recovered from acute toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy.
Beschreibung

cancer treatment | rituximab | Nitrosourea | Mitomycin-c | Toxicity Associated with Operative Surgical Procedures | Toxicity Associated with Therapeutic radiology procedure | Toxicity Associated with Chemotherapy | Toxicity Associated with Immunotherapy | Patient recovered

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0393022
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0002475
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C0332281
UMLS CUI [5,3]
C0543467
UMLS CUI [6,1]
C0600688
UMLS CUI [6,2]
C0332281
UMLS CUI [6,3]
C1522449
UMLS CUI [7,1]
C0600688
UMLS CUI [7,2]
C0332281
UMLS CUI [7,3]
C0392920
UMLS CUI [8,1]
C0600688
UMLS CUI [8,2]
C0332281
UMLS CUI [8,3]
C0021083
UMLS CUI [9]
C1115804
2. previously treated patients with a histology of refractory/relapsed indolent lymphomas including: (a) extranodal marginal lymphoma of malt type; (b) nodal marginal zone b-cell lymphoma (+/- monocytoid cells); (c) splenic marginal b-cell lymphoma (+/- villous lymphocytes).
Beschreibung

Patients Treated | Indolent lymphoma refractory | Indolent lymphoma Relapse | Extranodal marginal zone B-cell lymphoma (MALT type) | Monocytoid B-cell lymphoma | Splenic Marginal Zone B-Cell Lymphoma | Splenic Marginal Zone B-Cell Lymphoma Villous Lymphocytes Not Present

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1334170
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C1334170
UMLS CUI [3,2]
C0277556
UMLS CUI [4]
C0852624
UMLS CUI [5]
C0855139
UMLS CUI [6]
C0349632
UMLS CUI [7,1]
C0349632
UMLS CUI [7,2]
C1519987
3. signed informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
4. age >/= 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
5. expected survival >/= 3 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
6. pre-study zubrod performance status of 0, 1, or 2
Beschreibung

Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
7. acceptable hematologic status within two weeks prior to patient registration, including: (a) absolute neutrophil count ([segmented neutrophils + bands] * total white blood count (wbc)) >/= 1,500/mm^3; (b) platelet counts >/= 100,000/mm^3.
Beschreibung

Hematologic function | Absolute neutrophil count | Segmented neutrophil count | Neutrophil Band Cells | Total white blood count | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C1168341
UMLS CUI [4]
C3661517
UMLS CUI [5]
C1271681
UMLS CUI [6]
C0032181
8. female patients who are not pregnant or lactating
Beschreibung

Gender Pregnancy Absent | Gender Breast Feeding Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0006147
UMLS CUI [2,3]
C0332197
9. men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician)
Beschreibung

Reproductive potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
10. patients previously on phase ii drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post treatment toxicities observed
Beschreibung

Pharmaceutical Preparations Previous | Toxicity Long-term Unexpected | Pharmaceutical Preparations Discontinued | Toxicity post treatment Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0443252
UMLS CUI [2,3]
C4055646
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1444662
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C2709088
UMLS CUI [4,3]
C0332197
11. patients determined to have < 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy) (this criteria must be strictly met for adequate patient safety.)
Beschreibung

Lymphoma Bone Marrow Involvement Percentage | Bone marrow aspirate examination | Bone marrow biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1517677
UMLS CUI [1,3]
C0439165
UMLS CUI [2]
C1271729
UMLS CUI [3]
C0005954
12. patient should have at least one lesion measuring >/= 2 cm in a single dimension.
Beschreibung

Lesion size Linear Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449453
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior myeloablative therapies with autologous bone marrow transplantation (abmt) or peripheral blood stem cell (pbsc) rescue.
Beschreibung

Myeloablative Chemotherapy | Autologous bone marrow transplant | Peripheral Stem Cell Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C1513784
UMLS CUI [2]
C0194037
UMLS CUI [3]
C0242602
2. platelet count< 100,000 cells/mm^3.
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
3. presence of hypocellular bone marrow.
Beschreibung

Bone marrow depression

Datentyp

boolean

Alias
UMLS CUI [1]
C0151773
4. patients with history of failed stem cell collection.
Beschreibung

Stem cell collection failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3827940
UMLS CUI [1,2]
C0231175
5. prior radioimmunotherapy
Beschreibung

Radioimmunotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0085101
6. presence of central nervous system (cns) lymphoma
Beschreibung

Central nervous system lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0742472
7. patients with hiv.
Beschreibung

HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
8. patients with pleural effusion
Beschreibung

Pleural effusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0032227
9. patients with abnormal liver function: total bilirubin > 2.0 mg/dl
Beschreibung

Liver Dysfunction | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1278039
10. patients with abnormal renal function: serum creatinine > 2.0 mg/dl
Beschreibung

Abnormal renal function | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0151746
UMLS CUI [2]
C0201976
11. patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional)
Beschreibung

Teleradiotherapy procedure Bone Marrow Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0419095
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
12. patients who have received short-acting growth factor support (leukine, neupogen, procrit) within 2 weeks prior to treatment or long-acting growth-factor support (aranesp), neulasta) within 4 weeks prior to treatment.
Beschreibung

Growth Factor Support Effective short-term | Leukine | Neupogen | Procrit | Growth Factor Support Effective long-term | Aranesp | Neulasta

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018284
UMLS CUI [1,2]
C0344211
UMLS CUI [1,3]
C1280519
UMLS CUI [1,4]
C0443303
UMLS CUI [2]
C0701500
UMLS CUI [3]
C0733468
UMLS CUI [4]
C0733467
UMLS CUI [5,1]
C0018284
UMLS CUI [5,2]
C0344211
UMLS CUI [5,3]
C1280519
UMLS CUI [5,4]
C0443252
UMLS CUI [6]
C1134440
UMLS CUI [7]
C1171279
13. serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives
Beschreibung

Disease Serious compromises Protocol Compliance | Communicable Disease Serious compromises Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C2945640
UMLS CUI [2,4]
C0525058
14. major surgery, other than diagnostic surgery, within four weeks
Beschreibung

major surgery | Diagnostic surgical procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0522769
15. evidence of transformation in the latest biopsy
Beschreibung

Cell transformation Evidence Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040682
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0005558
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Ähnliche Modelle

Eligibility Lymphoma NCT00493454

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00493454
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
cancer treatment | rituximab | Nitrosourea | Mitomycin-c | Toxicity Associated with Operative Surgical Procedures | Toxicity Associated with Therapeutic radiology procedure | Toxicity Associated with Chemotherapy | Toxicity Associated with Immunotherapy | Patient recovered
Item
1. no anti-cancer therapy for three weeks (six weeks if rituximab, nitrosourea or mitomycin c) prior to study initiation, and fully recovered from acute toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy.
boolean
C0920425 (UMLS CUI [1])
C0393022 (UMLS CUI [2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0600688 (UMLS CUI [5,1])
C0332281 (UMLS CUI [5,2])
C0543467 (UMLS CUI [5,3])
C0600688 (UMLS CUI [6,1])
C0332281 (UMLS CUI [6,2])
C1522449 (UMLS CUI [6,3])
C0600688 (UMLS CUI [7,1])
C0332281 (UMLS CUI [7,2])
C0392920 (UMLS CUI [7,3])
C0600688 (UMLS CUI [8,1])
C0332281 (UMLS CUI [8,2])
C0021083 (UMLS CUI [8,3])
C1115804 (UMLS CUI [9])
Patients Treated | Indolent lymphoma refractory | Indolent lymphoma Relapse | Extranodal marginal zone B-cell lymphoma (MALT type) | Monocytoid B-cell lymphoma | Splenic Marginal Zone B-Cell Lymphoma | Splenic Marginal Zone B-Cell Lymphoma Villous Lymphocytes Not Present
Item
2. previously treated patients with a histology of refractory/relapsed indolent lymphomas including: (a) extranodal marginal lymphoma of malt type; (b) nodal marginal zone b-cell lymphoma (+/- monocytoid cells); (c) splenic marginal b-cell lymphoma (+/- villous lymphocytes).
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1334170 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C1334170 (UMLS CUI [3,1])
C0277556 (UMLS CUI [3,2])
C0852624 (UMLS CUI [4])
C0855139 (UMLS CUI [5])
C0349632 (UMLS CUI [6])
C0349632 (UMLS CUI [7,1])
C1519987 (UMLS CUI [7,2])
Informed Consent
Item
3. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
4. age >/= 18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
5. expected survival >/= 3 months
boolean
C0023671 (UMLS CUI [1])
Zubrod Performance Status
Item
6. pre-study zubrod performance status of 0, 1, or 2
boolean
C3714786 (UMLS CUI [1])
Hematologic function | Absolute neutrophil count | Segmented neutrophil count | Neutrophil Band Cells | Total white blood count | Platelet Count measurement
Item
7. acceptable hematologic status within two weeks prior to patient registration, including: (a) absolute neutrophil count ([segmented neutrophils + bands] * total white blood count (wbc)) >/= 1,500/mm^3; (b) platelet counts >/= 100,000/mm^3.
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C1168341 (UMLS CUI [3])
C3661517 (UMLS CUI [4])
C1271681 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
Gender Pregnancy Absent | Gender Breast Feeding Absent
Item
8. female patients who are not pregnant or lactating
boolean
C0079399 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Reproductive potential Contraceptive methods
Item
9. men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician)
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Pharmaceutical Preparations Previous | Toxicity Long-term Unexpected | Pharmaceutical Preparations Discontinued | Toxicity post treatment Absent
Item
10. patients previously on phase ii drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post treatment toxicities observed
boolean
C0013227 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
C4055646 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0600688 (UMLS CUI [4,1])
C2709088 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Lymphoma Bone Marrow Involvement Percentage | Bone marrow aspirate examination | Bone marrow biopsy
Item
11. patients determined to have < 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy) (this criteria must be strictly met for adequate patient safety.)
boolean
C0024299 (UMLS CUI [1,1])
C1517677 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C1271729 (UMLS CUI [2])
C0005954 (UMLS CUI [3])
Lesion size Linear Quantity
Item
12. patient should have at least one lesion measuring >/= 2 cm in a single dimension.
boolean
C0449453 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Myeloablative Chemotherapy | Autologous bone marrow transplant | Peripheral Stem Cell Transplantation
Item
1. prior myeloablative therapies with autologous bone marrow transplantation (abmt) or peripheral blood stem cell (pbsc) rescue.
boolean
C1513784 (UMLS CUI [1])
C0194037 (UMLS CUI [2])
C0242602 (UMLS CUI [3])
Platelet Count measurement
Item
2. platelet count< 100,000 cells/mm^3.
boolean
C0032181 (UMLS CUI [1])
Bone marrow depression
Item
3. presence of hypocellular bone marrow.
boolean
C0151773 (UMLS CUI [1])
Stem cell collection failed
Item
4. patients with history of failed stem cell collection.
boolean
C3827940 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Radioimmunotherapy
Item
5. prior radioimmunotherapy
boolean
C0085101 (UMLS CUI [1])
Central nervous system lymphoma
Item
6. presence of central nervous system (cns) lymphoma
boolean
C0742472 (UMLS CUI [1])
HIV Infection
Item
7. patients with hiv.
boolean
C0019693 (UMLS CUI [1])
Pleural effusion
Item
8. patients with pleural effusion
boolean
C0032227 (UMLS CUI [1])
Liver Dysfunction | Serum total bilirubin measurement
Item
9. patients with abnormal liver function: total bilirubin > 2.0 mg/dl
boolean
C0086565 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Abnormal renal function | Creatinine measurement, serum
Item
10. patients with abnormal renal function: serum creatinine > 2.0 mg/dl
boolean
C0151746 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Teleradiotherapy procedure Bone Marrow Percentage
Item
11. patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional)
boolean
C0419095 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Growth Factor Support Effective short-term | Leukine | Neupogen | Procrit | Growth Factor Support Effective long-term | Aranesp | Neulasta
Item
12. patients who have received short-acting growth factor support (leukine, neupogen, procrit) within 2 weeks prior to treatment or long-acting growth-factor support (aranesp), neulasta) within 4 weeks prior to treatment.
boolean
C0018284 (UMLS CUI [1,1])
C0344211 (UMLS CUI [1,2])
C1280519 (UMLS CUI [1,3])
C0443303 (UMLS CUI [1,4])
C0701500 (UMLS CUI [2])
C0733468 (UMLS CUI [3])
C0733467 (UMLS CUI [4])
C0018284 (UMLS CUI [5,1])
C0344211 (UMLS CUI [5,2])
C1280519 (UMLS CUI [5,3])
C0443252 (UMLS CUI [5,4])
C1134440 (UMLS CUI [6])
C1171279 (UMLS CUI [7])
Disease Serious compromises Protocol Compliance | Communicable Disease Serious compromises Protocol Compliance
Item
13. serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C2945640 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
major surgery | Diagnostic surgical procedure
Item
14. major surgery, other than diagnostic surgery, within four weeks
boolean
C0679637 (UMLS CUI [1])
C0522769 (UMLS CUI [2])
Cell transformation Evidence Biopsy
Item
15. evidence of transformation in the latest biopsy
boolean
C0040682 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
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