Trial · NCT01611090
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to 5 years | PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); \>=50% increase in existing lymph nodes; \>=50% increase in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte count (and to \>=5\*10\^9/L) or \>=50% increase from nadir count confirmed on \>=2 serial assessments if absolute lymphocyte count (ALC) \>=30,000 per microliter and lymphocyte doubling time is rapid, unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b \[Hgb\] or platelets) attributable to CLL; and transformation to a more aggressive histology. |
| Secondary | Overall Response Rate (ORR) | Up to 5 years | ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils \>1.5\*10\^9/liter (L), platelets \>100\*10\^9/L, Hgb \>11 gram per deciliter (g/dL) and absolute lymphocyte count \<4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR-2 of the following when abnormal at baseline: \>=50% decrease in ALC, \>=50% decrease in sum products of up to 6 lymph nodes, \>=50% decrease in enlargement of spleen or liver; and 1 of the following: neutrophils \>1.5\*10\^9/L, Platelets \>100\*10\^9/L and Hgb\>11 g/dL or \>=50% improvement over baseline in any of these; no new enlarged nodes or new hepatosplenomegaly. |
| Secondary | Overall Survival (OS) | Up to 5 years | OS was defined as the interval between the date of randomization and the date of death from any cause. |
| Secondary | Percentage of Participants With Minimal Residual Disease (MRD)-Negative Response | Up to 5 years | MRD-negative response was defined as the percentage of participants who reach MRD negative disease status (less than 1 chronic lymphocytic leukemia \[CLL\] cell per 10,000 leukocytes) in either bone marrow or peripheral blood. All randomized participants were included in this analysis. Participants with missing MRD data were considered non-responders. |
| Secondary | Percentage of Participants With Sustained Hematologic Improvement | Up to 5 years | Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (\>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (\>)100\* 109/liter (L) if baseline less than or equal to (\<=) 100\*109/L or increase \>= 50 percent (%) over baseline; 2) Hemoglobin \>11 gram per deciliters (g/dL) if baseline \<= 11 g/dL or increase \>= 2 g/dL over baseline. |
| Secondary | Median Time to Clinically Meaningful Improvement in FACIT-Fatigue Scale | Up to 2 years | Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
| Secondary | Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms | From the date of randomization to disease progression (Up to 2 years) | The disease-related symptoms included fatigue, weight loss, fevers, night sweats, abdominal discomfort/splenomegaly and anorexia. |
| Secondary | Number of Participants Who Received Subsequent Antineoplastic Therapy | Up to 5 years | Number of participants who received subsequent antineoplastic therapy was reported. |
| Secondary | Change From Baseline in Beta2 Microglobulin at End of Treatment (EOT) | Baseline to EOT (Up to 2 years) | Change from baseline in beta2 microglobulin at end of treatment at time of primary analysis was reported. |
| Secondary | Change From Baseline in FACIT-Fatigue Scale at End of Treatment | Baseline to EOT (up to 2 years) | FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
| Secondary | Change From Baseline in EORTC QLQ-C30 Physical Functioning Score at End of Treatment | Baseline to EOT (up to 2 years) | EORTC QLQ-C30 Physical Functioning Score is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which was rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. All scale and item scores were linearly transformed to be in range from 0-100. A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms. |
| Secondary | Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment | Baseline to EOT (up to 2 years) | The EORTC QLQ-CLL 16 is a 16-item disease specific module that comprises 5 domains of patient-reported health status important in CLL. There are three multi-item scales that include fatigue (2 items), treatment side effects and disease symptoms (8 items), and infection (4 items), and 2 single-item scales on social activities and future health worries. Responses are measured on a 4 point scale ranging from 1 (not at all) to 4 (very much). |
| Secondary | Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale at End of Treatment | Baseline to EOT (up to 2 years) | The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). |
| Secondary | Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Utility Score Scale at End of Treatment | Baseline to EOT (up to 2 years) | The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1. High score indicating a high level of utility. |
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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