Trial · NCT00877006
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Response (CR) at End of Treatment Period | 6 to 8 21 or 28-day cycles (18-32 weeks) | CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies. |
| Secondary | Percentage of Participants With Overall Response at End of Treatment Period | 6 to 8 21 or 28-day cycles (18-32 weeks) | Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria. |
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period | 32 weeks | AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one's ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event. |
| Secondary | Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results | 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit) | Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles). |
| Secondary | Worst Overall CTCAE Grade for Hematology Laboratory Test Results | 32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit) | Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles). |
| Secondary | Clinically Significant Abnormal Vital Signs | 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit) | |
| Secondary | Potentially Clinically Significant Abnormal Weight | Baseline, Week 32 | Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of \>=10% were considered potentially clinically significant. |
| Secondary | Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period | Week 32 | Participants' ECOG Performance Status was evaluated at the end of treatment as improved, stayed the same, or worsened from baseline (see Baseline Characteristics for ECOG Performance Status). |
| Secondary | Therapeutic Classification of Prior Medications | prior to start of treatment | |
| Secondary | Therapeutic Classification of Concomitant Medications | 32 weeks | |
| Secondary | Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30) | Day 1 (prior to treatment), 32 weeks | EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life. |
| Secondary | Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period | Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period | Relapsed disease (after CR) and progressive disease (PD) (after PR or SD): * Lymph nodes were considered abnormal if the long axis was greater than 1.5 cm. Lymph nodes with a long axis of 1.1 to 1.5 cm were considered abnormal if its short axis was greater than 1.0 cm. * In patients with no prior history of pulmonary lymphoma, new lung nodules identified by CT require histologic confirmation. * \>= 50% increase from nadir in sum of the products of the greatest diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must have increased by 2: 50% and to a size of 1.5 cm by 1.5 cm, or more than 1.5 cm in the long axis * other conditions as specified in the protocol |
| Secondary | Kaplan-Meier Estimate for Progression-free Survival (PFS) | Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period) | PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first. |
| Secondary | Kaplan-Meier Estimate for Event-free Survival (EFS) | Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period) | EFS was defined as the time from randomization to treatment failure, disease progression or relapse, other malignancies, or death from any cause, whichever occurred first. Treatment failure was defined as failure to achieve a CR or PR after 6 cycles of treatment. If a patient failed to achieve CR or PR by the time of data analysis or early withdrawal, the treatment failure date was set at 126 days (6 cycles of treatment) after randomization or the new anticancer treatment date, whichever is earlier. |
| Secondary | Kaplan-Meier Estimate for Duration of Response (DOR) | Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period) | DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause. |
| Secondary | Overall Survival (OS) | Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period) | OS was defined as the time from randomization to death from any cause. |
| Secondary | Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period | Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period | Death is due to any cause. Data are broken out by patients who died within 30 days of the last dose of study medications, and those who died greater than 30 days of the last dose of study medications. |
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.
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