Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03516617 · ClinicalTrials.gov registry record · Phase 2

Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Mayo Clinic.

Recruiting
Registry status
Phase 2
Development phase
120
Enrollment target
3
Study locations

NCT03516617: Recruiting Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Mayo Clinic.

NCT03516617 is a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 120 participants, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (34% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03516617, a Phase 2 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is actively recruiting participants, sponsored by Mayo Clinic.

RECRUITING
Registry status
Phase 2
Development phase
120 participants
Enrollment target
3
Study locations

Study Summary

This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.

Primary Outcome

Defined as an objective status of complete response (CR) or CR with incomplete marrow recovery (CRi) along with MRD negativity in the bone marrow by flow cytometry. Will be compared between the two arms. The proportion of successes will be estimated in each arm by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated in each arm based on the normal approximation. Comparison of MRD-neg

Conditions Studied

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Laboratory Biomarker Analysis
  • DRUG Acalabrutinib
  • BIOLOGICAL Obinutuzumab
  • OTHER Patient Observation

Study Locations (3)

Arizona

  • Mayo Clinic in Arizona - Scottsdale

Florida

  • Mayo Clinic in Florida - Jacksonville

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2018-09-10
Est. Completion 2030-10-16
Phase Phase 2
Mayo Clinic

2,844 total trials

What NCT03516617 shows while recruiting

NCT03516617 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (34% lower).

The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.

NCT03516617 reports a single indexed study location in Arizona, Florida, Minnesota.

Frequently Asked Questions

What is clinical trial NCT03516617 about?

NCT03516617 is a clinical study titled "Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". This phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunothe...

What is the current status of trial NCT03516617?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2018-09-10. Estimated completion is 2030-10-16.

What conditions does trial NCT03516617 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.

What interventions are being tested in trial NCT03516617?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Acalabrutinib (DRUG), Obinutuzumab (BIOLOGICAL), Patient Observation (OTHER).

Who is sponsoring clinical trial NCT03516617?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03516617 being conducted?

This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Chronic Lymphocytic Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03516617's enrollment target sits among peer trials

120 56th of 187 higher than 130 of 187 other Chronic Lymphocytic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01174108 · 120 participants · Phase 2

    Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells

  • NCT01627301 · 120 participants · NA

    Sympathetic Overactivity in Post-traumatic Stress Disorder

  • NCT02025023 · 120 participants · Phase 3

    Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study

  • NCT02128906 · 120 participants · Phase 2

    Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT03516617

Source: ClinicalTrials.gov NCT03516617, the US trial registry maintained by the National Library of Medicine. NCT03516617 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.