Prognosis of Patients With Relapsed/Refractory Hodgkin Lymphoma Treated With IGEV Induction Therapy Before HDCT With AHSCT (IIL-ProHLRec)
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| First Received Date ICMJE | October 17, 2011 | ||||||||
| Last Updated Date | March 5, 2013 | ||||||||
| Start Date ICMJE | May 2010 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
The prognostic score will be defined taking into account Overall Survival (OS). [ Time Frame: 4 years ] [ Designated as safety issue: No ] Surviving patents will be censored at the date of last known to be alive. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01478191 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
To evaluate the defined prognostic score in terms of Progression Free Survival (PFS) [ Time Frame: 4 years ] [ Designated as safety issue: No ] response rate in terms of Complete Response (CR) response rate in terms of Overall Response Rate (ORR) To validate the prognostic scores in terms of PFS and in terms OS |
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| Original Secondary Outcome Measures ICMJE |
To evaluate the defined prognostic score in terms of Progression Free Survival (PFS) [ Time Frame: 4 years ] [ Designated as safety issue: No ] response rate in terms of CR response rate in terms of ORR To validate the prognostic scores in terms of PFS and in terms OS |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prognosis of Patients With Relapsed/Refractory Hodgkin Lymphoma Treated With IGEV Induction Therapy Before HDCT With AHSCT | ||||||||
| Official Title ICMJE | Prognosis of Patients With Relapsed/Refractory Hl Treated With Combination of Ifosfamide, Gemcitabine and Vinorelbine(IGEV) Induction Therapy Before High-dose Chemotherapy (HDCT) With Autologous Hematopoietic Stem Cells Transplantation (AHSCT) | ||||||||
| Brief Summary | This is a retrospective analysis of a homogeneous cohort of patients with relapsed/refractory HL that received IGEV scheme as induction therapy to HDCT and AHSCT for reassess the most common prognostic factors and try to identify a prognostic score with clinical and therapeutic relevance by using 6 clinical tools:
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Cases of relapsed/refractory Hodgkin Limphoma (HL) which received full course IGEV scheme as induction therapy prior to HDCT with AHSCT from 1997 through 2007. Patients will be identified from archives of every single Center Registry database. |
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| Condition ICMJE | Hodgkin's Lymphoma | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 495 | ||||||||
| Completion Date | June 2011 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Refractory = non CR with last chemotherapy line, or progression during last treatment, or disease progression within three months from previous treatment completion).
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Italy | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01478191 | ||||||||
| Other Study ID Numbers ICMJE | IIL-ProHLRec, 30 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Fondazione Italiana Linfomi ONLUS | ||||||||
| Study Sponsor ICMJE | Fondazione Italiana Linfomi ONLUS | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Fondazione Italiana Linfomi ONLUS | ||||||||
| Verification Date | November 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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