A Study of MabThera (Rituximab) Plus Chlorambucil in Participants With Chronic Lymphocytic Leukemia.

March 6, 2016 updated by: Hoffmann-La Roche

An Open-Label Study to Characterize the Safety and Response Rate of MabThera (Rituximab) Plus Chlorambucil in Previously Untreated Patients With CD20-Positive B-Cell Chronic Lymphocytic Leukemia

This single arm study will assess the safety and effect on response rate of a combination of rituximab and chlorambucil in previously untreated participants with B-cell chronic lymphocytic leukemia. Participants will receive 6 monthly cycles of combination treatment, followed by up to 6 cycles of chlorambucil alone. Rituximab will be administered on Day 1 of each cycle, at a dose of 375 milligrams per square meter (mg/m^2) intravenously (IV) in Cycle 1, and 500 mg/m^2 in subsequent cycles, and chlorambucil will be administered on Days 1-7 of each cycle at a dose of 10 mg/m^2/day per oral (PO).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
      • Bournemouth, United Kingdom, BH7 7DW
      • Cambridge, United Kingdom, CB2 0QQ
      • Canterbury, United Kingdom, CT1 3NE
      • Cottingham, United Kingdom, HU16 5JQ
      • Leeds, United Kingdom, LS9 7TF
      • Leicester, United Kingdom, LE1 5WW
      • Liverpool, United Kingdom, L7 8XP
      • London, United Kingdom, EC1M 6BQ
      • London, United Kingdom, NW1 2PG
      • Sutton, United Kingdom, SM2 5PT
      • Wakefield, United Kingdom, WF1 4DG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • previously untreated participants with cluster of differentiation 20 (CD20) positive B-cell chronic lymphocytic leukemia;
  • participants with progressive Binet stage B, or C requiring therapy according to National Cancer Institute (NCI) criteria;
  • Eastern Cooperative Oncology Group (ECOG) performance status <=2.

Exclusion Criteria:

  • previous treatment for Chronic Lymphocytic Leukaemia (CLL);
  • known concomitant hematological malignancy;
  • transformation to aggressive B-cell malignancy;
  • history of severe cardiac disease;
  • known hypersensitivity or anaphylactic reactions to murine antibodies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rituximab plus Chlorambucil
Participants will receive combination therapy of rituximab plus chlorambucil for first 6 cycles and then chlorambucil alone for a maximum of 6 additional cycles.
Drug: Rituximab
375mg/m^2 IV on Day 1 of Cycle 1; 500mg/m^2 on Day 1 of Cycles 2-6.
Other Names:
  • Rituxan
  • MabThera
Drug: Chlorambucil
10 mg/m^2/day PO on Days 1 to 7 of each cycle for a maximum of 12 cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment-Emergent Adverse Events (AEs)
Time Frame: First administration of study treatment up to 56 days after the beginning of the last treatment cycle (up to 365 days)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 56 days from the beginning of the last treatment cycle that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs as well as non-serious AEs.
First administration of study treatment up to 56 days after the beginning of the last treatment cycle (up to 365 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Best Overall Response (BOR) of Clinical CR or Confirmed CR
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Clinical CR was achieved if all of the following criteria were met: a)Absence of lymphadenopathy (LD) by physical examination (PE) and Computed Tomography (CT) scan (all lymph nodes less than [<] 1.5 centimeters [cm] in diameter), b)No hepatomegaly (HM)/splenomegaly (SM) by PE/CT scan, c)Absence of B symptoms (unexplained fever greater than [>] 38 degrees [°] Centigrade [C], drenching night sweats/>10 percent [%] body weight loss in the last 6 months), d)Normal Complete Blood Count (CBC) (i. Leukocytes (Leuk) greater than or equal to [≥] 1.5×10^9 per liter (/L), ii. Platelets (Plat) >100×10^9/L, and iii. Haemoglobin (Hb) >11.0 grams per deciliter [g/dL]) and e)Once clinical, radiological and laboratory evaluations demonstrated CR, bone marrow (BM) biopsy and aspirate were performed 8 weeks later for confirmation; BM sample: normocellular for age, <30% of the cells being lymphocytes (Lym) and lymphoid nodules (LN) absent was considered as a confirmed CR.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Percentage of Participants With BOR of Partial Response (PR)
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
PR was achieved if all of the following criteria were met: a)≥50% decrease in Lym count from the baseline value, b)≥50% reduction in LD by CT scan, c)≥50% reduction in size of liver/spleen by PE/CT scan and at least 1 of the following for a minimum of 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. Participants who fulfilled criteria for CR with persistent anemia/thrombocytopenia were considered in PRs. CR was achieved if all of the criteria were fulfilled for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Percentage of Participants With BOR of Nodular Partial Response (nPR)
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
CR was achieved if all of the following criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. Participants with nPR were those who satisfied all of the CR criteria except for the BM, where LN could be identified histologically.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Percentage of Participants With BOR of Progressive Disease (PD)
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of hepatosplenomegaly (HSM) as determined by PE/CT scan; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Percentage of Participants With BOR of Stable Disease (SD)
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Participants without CR/PR or PD were considered having a tumor response of SD. CR: a) Absence of LD by PE and CT, b) No HM/SM by PE/CT, c) Absence of B symptoms, d) Normal CBC, and e) BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR: a) ≥50% decrease in Lym count from baseline, b) ≥50% reduction in LD, c) ≥50% reduction in size of liver/spleen by PE/CT and ≥1 of the following for at least 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. PD: a) ≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size or appearance of new lymph nodes/extranodal lesions, or b) ≥50% increase in the size of HSM; new appearance of palpable HM/SM, or c) ≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, or d) Transformation to a more aggressive histology.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Percentage of Participants With Objective Response (CR or PR)
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Objective response was defined as a tumor response of CR or PR. CR was achieved if all of the criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR was achieved if all of the criteria were met: a)≥50% decrease in Lymp count from the baseline value, b)≥50% reduction in LD by CT scan, c)≥50% reduction in size of liver/spleen by PE/CT scan and at least 1 of the following for a minimum of 8 weeks: i. Leuk ≥1.5×10^9/L or 50% improvement over baseline, ii. Plat >100×10^9/L or 50% improvement over baseline and iii. Hb >11.0 g/dL or 50% improvement over baseline without transfusion. Participants who fulfilled criteria for CR with persistent anemia/thrombocytopenia were considered PRs.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Percentage of Participant With Disease Progression or Death
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of HSM as determined by PE/CT scan; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Progression Free Survival (PFS) Time
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
PFS was defined as the interval (in days) from trial treatment start date to earlier of the date of first tumor response assessment of PD or date of death by any cause. Participants who experienced none of these events or who were lost to follow-up at the time of analysis were censored on last date when they were assessed for tumor response. PD is considered if 1 of the following criteria is met: a)≥50% increase in sum of products of ≥2 lymph nodes compared to their smallest size (at least one ≥2 cm in diameter) or appearance of new lymph nodes/extranodal lesions, b)≥50% increase in the size of HSM as determined by PE/CT; appearance of palpable HM/SM that was not previously present, c)≥50% increase in the number of circulating Lym to ≥5×10^9/L, d)Transformation to a more aggressive histology. Symptomatic deterioration (evident in clinical symptoms but not supported by tumor assessments), in such cases, the determination of clinical progression was based on symptomatic deterioration.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Disease Free Survival (DFS) Time
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
DFS time was defined as interval (in days) from first tumor response of CR to date of first tumor response of PD, or date of death by any cause. Participants who experienced none of these events or who were lost to follow-up at the time of analysis were censored on last date when they were assessed for tumor response. CR: a) Absence of LD by PE and CT, b) No HM/SM by PE/CT, c) Absence of B symptoms, d) Normal CBC, and e) BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PD: a) ≥50% increase in sum of the products of ≥2 lymph nodes compared to their smallest size or appearance of new lymph nodes/extranodal lesions, or b) ≥50% increase in the size of HSM; new appearance of palpable HM/SM, or c) ≥50% increase in the absolute number of circulating Lym to ≥5×10^9/L, or d) Transformation to a more aggressive histology.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Duration of Response (DoR)
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
DoR: defined as interval (in days) from first tumor response (of CR/PR/nPR) to earlier of date of PD/death. Participants without PD/death or who were lost to follow-up were censored. CR: a)Absence of LD by PE and CT, b)No HM/SM by PE/CT, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent. PR: a)≥50% decrease in Lym count from baseline value, b)≥50% reduction in LD, c)≥50% reduction in size of liver/spleen by PE/CT scan and d)Leuk, Plat and Hb ≥1.5×10^9/L, >100×10^9/L and >11.0 g/dL, respectively or 50% improvement (of all the 3) over baseline value. nPR: participants who satisfied all of CR criteria except for BM, where LN could be identified. PD: a)≥50% increase in sum of the products of ≥2 lymph nodes or appearance of new lymph nodes/extranodal lesions, or b)≥50% increase in size of HSM; new appearance of palpable HM/SM, or c)≥50% increase in number of Lym, or d)Transformation to a more aggressive histology.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Percentage of Participants Who Died
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Overall Survival (OS) Time
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
This was defined as the interval (number of days) from the trial treatment start date to the date of death by any cause. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Percentage of Participants Who Achieved Minimal Residual Disease (MRD) Negativity
Time Frame: Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
MRD negativity was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a confirmed CR. CR was achieved if all of the following criteria were met for ≥8 weeks: a)Absence of LD by PE and CT scan, b)No HM/SM by PE/CT scan, c)Absence of B symptoms, d)Normal CBC, and e)BM biopsy: normocellular for age, <30% of the cells being Lym and LN absent.
Baseline until disease progression or death up to approximately 2.5 years (assessed at Baseline, Cycle 4 Day 1, Day 1 of Cycles 7-12, and thereafter every 3 months up to approximately 2.5 years; cycle length = 28 days)
Mean Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scores
Time Frame: Baseline, Day 1 of Cycles 5 and 11, end of follow-up (FU) (24 month [m] FU visit, up to approximately 3 years)
EORTC QLQ-C30: included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global Qol/functional scales=better level of QoL/functioning, or a higher score for symptom scale=greater degree of symptoms.
Baseline, Day 1 of Cycles 5 and 11, end of follow-up (FU) (24 month [m] FU visit, up to approximately 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MO20927
  • 2007-000172-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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