ID

18445

Beschreibung

Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00387023

Link

https://clinicaltrials.gov/show/NCT00387023

Stichworte

Versionen (2)
  1. 04.11.16 04.11.16 -
  2. 05.11.16 05.11.16 -
Hochgeladen am

5. November 2016

DOI

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Eligibility Non-Hodgkin's Lymphoma NCT00387023

Englisch

Eligibility Non-Hodgkin's Lymphoma NCT00387023

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. biopsy-proven diagnosis of low-grade non-hodgkin's follicular lymphoma of the orbit or malt of the conjunctiva/orbit. the orbit/conjunctiva has to be the primary or predominant site of involvement or if there is a previous history of systemic involvement, the orbit/conjunctiva should be the only site of new recurrence.
Beschreibung

Follicular Lymphoma Low grade Orbit | Orbital lymphoma | Mucosa-Associated Lymphoid Tissue Lymphoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024301
UMLS CUI [1,2]
C1962916
UMLS CUI [1,3]
C0029180
UMLS CUI [2]
C0271333
UMLS CUI [3]
C0242647
2. no anti-cancer therapy for three weeks (six weeks if rituximab, nitrosourea or mitomycin c) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy
Beschreibung

cancer treatment | rituximab | Nitrosourea | Mitomycin | Operative Surgical Procedures | prior radiation therapy | Prior Chemotherapy | Prior Immunotherapy | Toxic effect Patient Recovered

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0393022
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0002475
UMLS CUI [5]
C0543467
UMLS CUI [6]
C0279134
UMLS CUI [7]
C1514457
UMLS CUI [8]
C1514461
UMLS CUI [9,1]
C0600688
UMLS CUI [9,2]
C0030705
UMLS CUI [9,3]
C0521108
3. an institutional review board (irb)-approved signed informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
4. age >18 years. this is justified since low-grade non-hodgkin's lymphoma of the orbit is extremely rare to non-existent in the pediatric population
Beschreibung

Age | adult low grade NHL

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0278885
5. expected survival of >3 months
Beschreibung

Continuance of life Expected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038952
UMLS CUI [1,2]
C1517001
6. pre-study performance status of 0, 1, or 2 according to the who
Beschreibung

WHO performance status scale

Datentyp

boolean

Alias
UMLS CUI [1]
C1298650
7. acceptable hematologic status within two weeks prior to patient registration, including: a) absolute neutrophil count ([segmented neutrophils + bands] x total wbc)> 1500/mm3 b) total lymphocyte count < 5,000/mm3 for patients with small lymphocytic lymphoma (iwfa) c) platelet counts> 150,000/mm3, these patients will receive a dose of 0.4 mci/kg of zevalin d) platelet counts from 100,00/mm3 to 149,000/mm3, these patients will receive a 0.3mci/kg dose of zevalin
Beschreibung

Hematologic function | Absolute neutrophil count | Segmented neutrophil count | Neutrophil band count | White Blood Cell Count procedure | Lymphocyte Count measurement | Small Lymphocytic Lymphoma | Platelet Count measurement | Zevalin

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C1168341
UMLS CUI [4]
C0200634
UMLS CUI [5]
C0023508
UMLS CUI [6]
C0200635
UMLS CUI [7]
C0855095
UMLS CUI [8]
C0032181
UMLS CUI [9]
C0919274
8. female patients who are not pregnant or lactating
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method)
Beschreibung

Fertility Contraceptive methods | Sexual Abstinence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0036899
10. patients previously on phase ii drugs are eligible 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

Investigational New Drugs | Toxic effect Long-term Expected | Investigational New Drug Discontinued

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0443252
UMLS CUI [2,3]
C1517001
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1444662
11. patients determined to have less than 25% bone marrow involvement with lymphoma within six weeks of registration (based on a bone marrow biopsy). (this criteria must be strictly met for adequate patient safety.)
Beschreibung

Lymphoma Bone Marrow Involvement Percentage | Bone marrow biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C1517677
UMLS CUI [1,3]
C0439165
UMLS CUI [2]
C0005954
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with impaired bone marrow reserve, as indicated by one or more of the following: a) prior myeloablative therapies with autologous bone marrow transplantation (abmt) or peripheral blood stem cell (pbsc) rescue b) platelet count < than 100,000 cells/mm3 c) hypocellular bone marrow (less than 15% cellularity) d) marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid)
Beschreibung

Few mature neutrophils in the bone marrow | Bone Marrow Purging | Autologous bone marrow transplant | Peripheral Stem Cell Transplantation | Platelet Count measurement | Bone marrow depression | Reduced or absent erythroid precursors in bone marrow

Datentyp

boolean

Alias
UMLS CUI [1]
C2748959
UMLS CUI [2]
C0085079
UMLS CUI [3]
C0194037
UMLS CUI [4]
C0242602
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0151773
UMLS CUI [7]
C3809890
2. prior radioimmunotherapy
Beschreibung

Radioimmunotherapy

Datentyp

boolean

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

Central nervous system lymphoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0742472
4. patients with hiv or aids-related lymphoma
Beschreibung

lymphoma; resulting from HIV disease | Lymphoma, AIDS-Related

Datentyp

boolean

Alias
UMLS CUI [1]
C1399703
UMLS CUI [2]
C0085090
5. patients with small lymphocytic lymphoma (iwf a) - who have a total lymphocyte count > 5,000/mm3
Beschreibung

Small Lymphocytic Lymphoma | Lymphocyte Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0855095
UMLS CUI [2]
C0200635
6. patients with pleural effusion
Beschreibung

Pleural effusion disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0032227
7. 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
8. 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
9. patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional)
Beschreibung

External Beam Radiation Therapy Bone Marrow Percentage | Involved-Field Radiation Therapy | Therapeutic radiology procedure regional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1517033
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2]
C3826993
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205147
10. patients who have received granulocyte colony-stimulating factor (g-csf or gm-csf) therapy within two weeks prior to treatment
Beschreibung

Granulocyte Colony-Stimulating Factor | Granulocyte-Macrophage Colony-Stimulating Factor

Datentyp

boolean

Alias
UMLS CUI [1]
C0079459
UMLS CUI [2]
C0079460
11. serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives
Beschreibung

Disease Serious At risk Protocol Compliance | Communicable Disease Serious At risk Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C0525058
12. major surgery, other than diagnostic surgery, within four weeks
Beschreibung

major surgery | Operative Surgical Procedure Diagnostic

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0348026
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Ähnliche Modelle

Eligibility Non-Hodgkin's Lymphoma NCT00387023

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Follicular Lymphoma Low grade Orbit | Orbital lymphoma | Mucosa-Associated Lymphoid Tissue Lymphoma
Item
1. biopsy-proven diagnosis of low-grade non-hodgkin's follicular lymphoma of the orbit or malt of the conjunctiva/orbit. the orbit/conjunctiva has to be the primary or predominant site of involvement or if there is a previous history of systemic involvement, the orbit/conjunctiva should be the only site of new recurrence.
boolean
C0024301 (UMLS CUI [1,1])
C1962916 (UMLS CUI [1,2])
C0029180 (UMLS CUI [1,3])
C0271333 (UMLS CUI [2])
C0242647 (UMLS CUI [3])
cancer treatment | rituximab | Nitrosourea | Mitomycin | Operative Surgical Procedures | prior radiation therapy | Prior Chemotherapy | Prior Immunotherapy | Toxic effect Patient Recovered
Item
2. no anti-cancer therapy for three weeks (six weeks if rituximab, nitrosourea or mitomycin c) prior to study initiation, and fully recovered from all 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])
C0543467 (UMLS CUI [5])
C0279134 (UMLS CUI [6])
C1514457 (UMLS CUI [7])
C1514461 (UMLS CUI [8])
C0600688 (UMLS CUI [9,1])
C0030705 (UMLS CUI [9,2])
C0521108 (UMLS CUI [9,3])
Informed Consent
Item
3. an institutional review board (irb)-approved signed informed consent
boolean
C0021430 (UMLS CUI [1])
Age | adult low grade NHL
Item
4. age >18 years. this is justified since low-grade non-hodgkin's lymphoma of the orbit is extremely rare to non-existent in the pediatric population
boolean
C0001779 (UMLS CUI [1])
C0278885 (UMLS CUI [2])
Continuance of life Expected
Item
5. expected survival of >3 months
boolean
C0038952 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
WHO performance status scale
Item
6. pre-study performance status of 0, 1, or 2 according to the who
boolean
C1298650 (UMLS CUI [1])
Hematologic function | Absolute neutrophil count | Segmented neutrophil count | Neutrophil band count | White Blood Cell Count procedure | Lymphocyte Count measurement | Small Lymphocytic Lymphoma | Platelet Count measurement | Zevalin
Item
7. acceptable hematologic status within two weeks prior to patient registration, including: a) absolute neutrophil count ([segmented neutrophils + bands] x total wbc)> 1500/mm3 b) total lymphocyte count < 5,000/mm3 for patients with small lymphocytic lymphoma (iwfa) c) platelet counts> 150,000/mm3, these patients will receive a dose of 0.4 mci/kg of zevalin d) platelet counts from 100,00/mm3 to 149,000/mm3, these patients will receive a 0.3mci/kg dose of zevalin
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C1168341 (UMLS CUI [3])
C0200634 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
C0200635 (UMLS CUI [6])
C0855095 (UMLS CUI [7])
C0032181 (UMLS CUI [8])
C0919274 (UMLS CUI [9])
Pregnancy | Breast Feeding
Item
8. female patients who are not pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Fertility Contraceptive methods | Sexual Abstinence
Item
9. men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method)
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0036899 (UMLS CUI [2])
Investigational New Drugs | Toxic effect Long-term Expected | Investigational New Drug Discontinued
Item
10. patients previously on phase ii drugs are eligible 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
C0013230 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
Lymphoma Bone Marrow Involvement Percentage | Bone marrow biopsy
Item
11. patients determined to have less than 25% bone marrow involvement with lymphoma within six weeks of registration (based on a bone marrow 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])
C0005954 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Few mature neutrophils in the bone marrow | Bone Marrow Purging | Autologous bone marrow transplant | Peripheral Stem Cell Transplantation | Platelet Count measurement | Bone marrow depression | Reduced or absent erythroid precursors in bone marrow
Item
1. patients with impaired bone marrow reserve, as indicated by one or more of the following: a) prior myeloablative therapies with autologous bone marrow transplantation (abmt) or peripheral blood stem cell (pbsc) rescue b) platelet count < than 100,000 cells/mm3 c) hypocellular bone marrow (less than 15% cellularity) d) marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid)
boolean
C2748959 (UMLS CUI [1])
C0085079 (UMLS CUI [2])
C0194037 (UMLS CUI [3])
C0242602 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0151773 (UMLS CUI [6])
C3809890 (UMLS CUI [7])
Radioimmunotherapy
Item
2. prior radioimmunotherapy
boolean
C0085101 (UMLS CUI [1])
Central nervous system lymphoma
Item
3. presence of central nervous system (cns) lymphoma
boolean
C0742472 (UMLS CUI [1])
lymphoma; resulting from HIV disease | Lymphoma, AIDS-Related
Item
4. patients with hiv or aids-related lymphoma
boolean
C1399703 (UMLS CUI [1])
C0085090 (UMLS CUI [2])
Small Lymphocytic Lymphoma | Lymphocyte Count measurement
Item
5. patients with small lymphocytic lymphoma (iwf a) - who have a total lymphocyte count > 5,000/mm3
boolean
C0855095 (UMLS CUI [1])
C0200635 (UMLS CUI [2])
Pleural effusion disorder
Item
6. patients with pleural effusion
boolean
C0032227 (UMLS CUI [1])
Liver Dysfunction | Serum total bilirubin measurement
Item
7. 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
8. patients with abnormal renal function: serum creatinine > 2.0 mg/dl
boolean
C0151746 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
External Beam Radiation Therapy Bone Marrow Percentage | Involved-Field Radiation Therapy | Therapeutic radiology procedure regional
Item
9. patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional)
boolean
C1517033 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C3826993 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0205147 (UMLS CUI [3,2])
Granulocyte Colony-Stimulating Factor | Granulocyte-Macrophage Colony-Stimulating Factor
Item
10. patients who have received granulocyte colony-stimulating factor (g-csf or gm-csf) therapy within two weeks prior to treatment
boolean
C0079459 (UMLS CUI [1])
C0079460 (UMLS CUI [2])
Disease Serious At risk Protocol Compliance | Communicable Disease Serious At risk Protocol Compliance
Item
11. 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])
C1444641 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
major surgery | Operative Surgical Procedure Diagnostic
Item
12. major surgery, other than diagnostic surgery, within four weeks
boolean
C0679637 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0348026 (UMLS CUI [2,2])
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