Trial Watch: Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
Important context
- Trial eligibility (participation has strict criteria): Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
In plain English
The 30-second version
What happened?
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
Why does it matter?
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
What does this not prove?
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Keep reading for evidence stage, limitations, study details, and sources.
What changed: ClinicalTrials.gov lists Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (NCT01886872) as a Phase 3 interventional cancer study. The registry status is Active Not Recruiting, with the record last updated 2026-10-22.
Study snapshot: Phase 3; Active Not Recruiting; planned enrollment 547. Conditions listed: Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia. A primary outcome listed by the registry is: Progression Free Survival (PFS).
This entry tracks verified trial-registry facts. Trial registration by itself does not show that an intervention is effective, safe for a particular person, FDA-approved for this use, or recommended by clinical guidelines.
Population / Applicability
Studied in: Participants age 65 Years and older with Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia who meet the study-specific registry eligibility criteria. (Adults)
Eligibility is study-specific. Registry information does not determine whether any individual should enroll in or receive the intervention.
Full evidence details
- Study design
- Other / not applicable
- Sample size
- 547
- Primary outcome
- Progression Free Survival (PFS)
- Replication
- Unknown
Funding & Conflicts
ClinicalTrials.gov lists the lead sponsor as National Cancer Institute (NCI). Sponsorship is reported for transparency and does not establish efficacy.
Regulatory status by jurisdiction
Unspecified jurisdiction
- Status
- Investigational
- Last verified
- 2026-10-23
This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.
Guideline positions
Guideline
- Position
- Not addressed
- Last verified
- 2026-10-23
Primary evidence supporting this story
- ClinicalTrials.gov — NCT01886872 (opens in a new tab) (Clinical-trial registry) NCT01886872 Load-bearing source NCT01886872
ClinicalTrials.gov — NCT01886872. NCT01886872.
Last reviewed
Trial Watch: Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
https://cancerdiscoveries.com/discoveries/trial-watch-rituximab-and-bendamustine-hydrochloride-rituximab-and-ibrutinib-or-ibrutinib-alone-in-treating-older-patients-with-previously-untreated-chronic-lymphocytic-leukemia/
Evidence stage: Later-Stage Human
What This Means
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
What This Doesn't Mean
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Why It Matters
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
Important Limitations
- Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
Primary sources
- ClinicalTrials.gov — NCT01886872 — https://clinicaltrials.gov/study/NCT01886872 (NCT01886872)
Date verified: 2026-10-23
Correction status: No correction or retraction