Trial · NCT01415752
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) for Induction Phase | Assessed at baseline, every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months | PFS is defined as time from randomization to lymphoma progression or death. Progression is defined as: * Appearance of any new lesion \>1.5 cm in any axis during or at the end of therapy * \>=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. * \>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. * Lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was PET positive before therapy unless the lesion is too small to be detected with current PET systems |
| Primary | Progression-free Survival (PFS) for Maintenance Phase (Step 2) | Assessed at registration to step 2, cycles 6, 12, 18, treatment completion, then every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months | PFS is defined as time from Step 2 registration to lymphoma progression or death. Progression is defined as: * Appearance of any new lesion \>1.5 cm in any axis during or at the end of therapy * \>=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. * \>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. * Lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was PET positive before therapy unless the lesion is too small to be detected with current PET systems |
| Secondary | Objective Response for Induction Phase (Step 1) | Assessed at baseline and 24 weeks (end of cycle 6) | Objective response is defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy. PR is defined as: * ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses * No increase in the size of other nodes, liver or spleen. * Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified, e.g. large-cell lymphoma or small cleaved cell lymphoma. * No new sites of disease. * Patients who achieve a CR but have persistent morphologic bone marrow involvement will be considered partial responders. * When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients are considered partial responders. |
| Secondary | PET-documented Complete Response for Induction Phase (Step 1) | Assessed at baseline and 24 weeks (end of cycle 6) | Complete response is defined as disappearance of all detectable clinical evidence of disease. |
| Secondary | Overall Survival (OS) Rate at 5 Years Since Maintenance (Step 2) | Assessed every 3 months for 2.5 years, every 6 months for years 2.5-5 | OS is defined as the time from registration of Step 2 (maintenance) until death from any cause or last know alive. The Kaplan-Meier estimate of 5-year OS rate is reported. |
| Secondary | Objective Response for Maintenance (Step 2) Among Patients Without PET-documented CR at the End of Induction | Assessed at baseline and every 4 months for 2 years | Objective response is defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy. PR is defined as: * ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses * No increase in the size of other nodes, liver or spleen. * Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified, e.g. large-cell lymphoma or small cleaved cell lymphoma. * No new sites of disease. * Patients who achieve a CR but have persistent morphologic bone marrow involvement will be considered partial responders. * When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients are considered partial responders. |
| Other | To Collect Paraffin Embedded Tissue for Creation of Tissue Microarray | Assessed at baseline | Collection of paraffin embedded tissue for creation of tissue microarray |
| Other | To Collect and Bank Serum and Blood Mononuclear Cells for Future Studies | Assessed at baseline, end of cycle 3, end of cycle 6, every 4 months during first year of maintenance, every 6 months during 2nd year of maintenance, and 12 months after completion of maintenance | Collecting and banking serum and blood mononuclear cells for future studies |
| Other | To Collect Formalin Fixed Paraffin Embedded (FFPE) Tissue to Analyze Potential Prognostic Factors | Assessed at baseline | Collection of formalin fixed paraffin embedded (FFPE) tissue for future analysis of potential prognostic factors |
| Other | Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx Subscale) Score | Assessed at baseline, 6, 12, 30, 36, 48 and 60 months | FACT/GOG-Ntx subscale has 11 items and the score ranges from 0 to 44. The higher the score, the better the quality of life. |
| Other | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale Score | Assessed at baseline, 6, 12, 30, 36, 48 and 60 months | FACIT-Fatigue scale has 14 items and the score ranges from 0 to 56. The higher the score, the better the quality of life. |
| Other | Functional Assessment of Cancer Therapy - General (FACT-G) Score | Assessed at baseline, 6, 12, 30, 36, 48 and 60 months | FACT-G subscale has 27 items and the score ranges from 0 to 108. The higher the score, the better the quality of life. |
| Other | To Evaluate the Effects of Bortezomib-related Neuropathy (FACT/GOG-Ntx Subscale Score) on Patient Reported Health-related Quality of Life (FACT-G Score). | Assessed at baseline, 6, 12, 30, 36, 48 and 60 months | FACT/GOG-Ntx subscale has 11 items and the score ranges from 0 to 44. FACT-G has 27 items and the score ranges from 0 to 108. The higher the score, the better the quality of life for both scales. |
| Other | Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lymphoma) Subscale Score | Assessed at baseline, 6, 12, 30, 36, 48 and 60 months | FACT-Lymphoma has 15 items and the score ranges from 0 to 60. The higher the score, the better the quality of life. |
| Other | To Evaluate the Response of Lymphoma-specific Symptoms to Treatment. | Assessed at baseline, 6, 12, 30, 36, 48 and 60 months | FACT-Lymphoma has 15 items and the score ranges from 0 to 60. The higher the score, the better the quality of life. |
| Other | The Trajectory of Overall Health-related Quality of Life | Assessed at baseline, 6, 12, 30, 36, 48 and 60 months | The overall health-related quality of life is evaluated using FACT-G. FACT-G subscale has 27 items and the score ranges from 0 to 108. The higher the score, the better the quality of life. |
| Other | To Assess the Proportion of Patients up and Down Staging When FDGPET/CT is Added to Standard Ann Arbor Staging. | Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years | Assessment of the proportion of patients up and down staging when FDGPET/CT is added to standard Ann Arbor staging will be performed. |
| Other | To Assess the Ability of Pre-treatment FDG-PET/CT Semi Quantitative Parameters Including SUVmax and Metabolic Measurements to Predict Response Rate and PFS. | Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years | To assess the ability of pre-treatment FDG-PET/CT semi quantitative parameters including SUVmax and metabolic measurements to predict response rate and PFS. |
| Other | Assessment of the Correlation of Interim FDG-PET/CT Imaging With Response Rate and PFS Both During Induction and Consolidation Therapy | Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years | Among patients with interim FDG-PET/CT imaging, to assess the correlation of interim FDG-PET/CT imaging with response rate and PFS both during induction and consolidation therapy. |
| Other | To Assess Standard FDG-PET/CT Metrics and Association With Pathology Features | Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years | To assess standard FDG-PET/CT metrics including SUVmax, tumor metabolic burden, total tumor burden, and association with pathology features (blastoid variant vs. other, and Ki67) in the setting of MCL. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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