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dbGaP phs001219 Detection of Genes Predisposing to Hematologic Malignancies - pht007857.v1.p1

- 26/04/23 - 6 moduli, 1 ItemGroup, 2 elementi, 1 linguaggio
ItemGroup: pht007857
Principal Investigator: Neil E. Caporaso, MD, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA MeSH: Leukemia, Lymphocytic, Chronic, B-Cell,Hodgkin Disease,Lymphoma, Non-Hodgkin,Waldenstrom Macroglobulinemia,Leukemia, Hairy Cell,Leukemia, Myeloid, Acute,Leukemia, Myelomonocytic, Juvenile https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001219 We have been conducting genetic studies on families at high risk of different hematologic malignancies, in order to define the related tumors in the families, define precursor and other related conditions, and map and identify susceptibility genes. We have focused mainly on four types of lymphoid malignancies: chronic lymphocytic leukemia (CLL), Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL), and Waldenström macroglobulinemia (WM). A few families with a rare lymphoma subtype, hairy cell leukemia (HCL) are included. In addition, single large pedigrees with acute myeloid leukemia (AML), and juvenile myelomocytic leukemia (JMML) are included. Families are ascertained for having at least two patients with the same hematologic malignancy and are classified by the type of malignancy that predominates in the family. Multiple types of lymphoid malignancies are often found in the same family. Other data has shown that these conditions aggregate together in families. Verification of cancer diagnoses is obtained through medical records, pathology reports, and flow cytometry. Family members with precursor traits are also included, monoclonal B-cell lymphocytosis (MBL) in CLL families and IgM monoclonal gammopathy of undetermined significance (MGUS) in WM families.

pht007858.v1.p1

1 ItemGroup 6 elementi

Eligibility

1 ItemGroup 1 elemento

pht007859.v1.p1

1 ItemGroup 3 elementi

pht007860.v1.p1

1 ItemGroup 10 elementi

pht007861.v1.p1

1 ItemGroup 5 elementi

dbGaP phs001284 NCI Waldenstrom Macroglobulinemia Genome-wide Association Study - Eligibility

- 23/03/23 - 5 moduli, 1 ItemGroup, 3 elementi, 1 linguaggio
ItemGroup: IG.elig
Principal Investigator: Neil E Caporaso, MD, National Institutes of Health, Bethesda, MD, USA MeSH: Waldenstrom Macroglobulinemia,Lymphoplasmacytoid Lymphoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001284 A discovery GWAS is performed, consisting of genotyping 221 Waldenstrom macroglobulinemia (WM) cases on the Illumina Omni Express 12v1.1 platform and analyzing the genotypes together with those of 3798 previously genotyped controls in a model taking into account gender, age, and principal components of ancestry (i.e., significant eigenvectors). Directly genotyped data are supplemented by imputation using the Haplotype Reference Consortium.

pht009031.v1.p1

1 ItemGroup 3 elementi

pht009032.v1.p1

1 ItemGroup 3 elementi

pht009033.v1.p1

1 ItemGroup 6 elementi

pht009034.v1.p1

1 ItemGroup 5 elementi

dbGaP phs000740 Whole Genome Sequencing of Waldenstrom's Macroglobulinemia - Eligibility

- 14/12/22 - 5 moduli, 1 ItemGroup, 1 elemento, 1 linguaggio
ItemGroup: IG.elig
Principal Investigator: Steven Treon, MD, PhD, Dana-Farber Cancer Institute, Boston, MA, USA MeSH: Waldenstrom Macroglobulinemia https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000740 Whole genome sequencing was conducted on 10 tumor/germline paired samples along with 20 additional unpaired tumor samples from patients with Waldesntrom's macroglobulinemia. Tumor lymphoplasmacytic lymphoma cells were obtained from CD19+ selected bone marrow mononuclear cells. Germline tissue was obtained from CD19 depleted peripheral blood mononuclear cells. High molecular weight DNA was then submitted for whole genome sequencing with Complete Genomics and aligned to HG19/NCBI human reference build 37.

pht003815.v1.p1

1 ItemGroup 5 elementi

pht003816.v1.p1

1 ItemGroup 5 elementi

pht003817.v1.p1

1 ItemGroup 3 elementi

pht003818.v1.p1

1 ItemGroup 6 elementi

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Electronically transferred lab data

- 26/11/21 - 1 modulo, 4 itemgroups, 9 elementi, 1 linguaggio
Itemgroups: Administrative Data, Blood sample, Neuro Antibody panel, Prognostic factors
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form is for documentation of electronically transferred lab data and is used for screening, cycle 1 weeks 1-4 and observation, cycle 2 weeks 1-4 and observation and on a potential withdrawal visit, as well as any unscheduled lab data available.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - PK Blood Sample

- 26/11/21 - 1 modulo, 3 itemgroups, 9 elementi, 1 linguaggio
Itemgroups: Administrative Data, Dosing date and time, PK Blood Sample
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Depending on which items, this form has to be filled out at the Cycle 1 week 1, 2, 3 and 4 visits, Cycle 2 week 1, 2, 3 and 4 visits, Cycle 1 and 2 observation visits and unscheduled visits.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Vital Signs

- 26/11/21 - 1 modulo, 2 itemgroups, 13 elementi, 1 linguaggio
Itemgroups: Administrative Data, Vital Signs
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the Screening Visit, the Cycle 1 week 1, 2, 3 and 4 visits, Cycle 2 week 1, 2, 3 and 4 visits and for unscheduled visits. Note: Not all items are required for all of these visits.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Liver imaging

- 26/11/21 - 1 modulo, 11 itemgroups, 61 elementi, 1 linguaggio
Itemgroups: Date of hepatic or liver imaging test, method used for imaging test, images technically adequate, liver size, liver texture, diffuse and/or geographic fatty infiltrate of the liver, Ascites present, Focal Hepatic Lesions characterisable, Gallstones or gallbladder lesions, Biliary ductal lesions, Portal/Hepatic vein abnormalities
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver imaging is performed (in case of a liver event).

On-Study - Waldenstroms Macroglobulinemia - On-Study Form - 2273908v3.0 - Waldenstroms Macroglobulinemia - On-Study Form

- 17/09/21 - 1 modulo, 5 itemgroups, 57 elementi, 1 linguaggio
Itemgroups: CRF Header, Waldenstrom's: Form Administration, Waldenstrom's: Disease Description, Waldenstrom's: Prior Treatment, Waldenstrom's: Relapsed Disease
Waldenstrom's Macroglobulinemia - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D6795205-A4D9-0CD9-E034-0003BA12F5E7

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Liver Events

- 30/08/21 - 1 modulo, 10 itemgroups, 57 elementi, 1 linguaggio
Itemgroups: Administrative Data, Liver chemistry result, Liver events, Liver Pharmacokinetics, Liver investigational product, Liver disease medical conditions, Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver events occur.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Additional Scan

- 25/08/21 - 1 modulo, 2 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Administrative Data, Other protocol specified and/or additional scan
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled whenever/if additional scans have to be done during study.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Pharmacogenetic Research

- 25/08/21 - 1 modulo, 3 itemgroups, 15 elementi, 1 linguaggio
Itemgroups: Administrative Data, Pharmacogenetic (PGx) Research Consent/Blood Sample Collection, Withdrawal of Consent for PGx (DNA) / Blood Sample Destruction
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out whenever/if Pharmacogenetic Research consent has to be given/withdrawn or blood samples have to be collected during study.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Serious Adverse event

- 25/08/21 - 1 modulo, 15 itemgroups, 99 elementi, 1 linguaggio
Itemgroups: Administrative Data, Type of Report, Randomisation, Serious Adverse Event, Intensity Changes Entry, Seriousness of Adverse event, Relevant concomitant/Treatment medications Entry, Relevant medical conditions/Risk factors entry, Serious Adverse Event, Relevant Diagnostic Results Entry, Serious Adverse Event, Rechallenge, Investigational Product, Investigational Product, Investigational Product, Serious adverse event, General Narrative Comments, Serious Adverse Event, Non Clinical
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out whenever/if a serious adverse event occurred during study.

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