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Chronic Lymphocytic LeukemiaPhase 1453 Ph1 CLLNCT06291220

A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

A Phase 1 study testing Obinutuzumab and ABBV-453 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by AbbVie at 21 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Obinutuzumab and ABBV-453
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
21 sitesin 5 countries
Study dates
27 Jan 2025to Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that has received at least 2 prior systemic therapies and have no available (or established) therapies known to provide clinical benefit and to which the participant would consent to receiving.
  • Laboratory values meeting those listed in the protocol.

Who cannot join

  • QT interval corrected for heart rate (QTc) using Fridericia's correction of > 470 msec (females) or > 450 msec (males), Grade 3 arrythmia, and/or other clinically significant cardiac abnormalities.
  • Known to be B-cell leukemia/lymphoma 2 inhibitor (BCL-2i) refractory or has received a BCL-2i-containing regimen within (6 months) of starting study drug (e.g., venetoclax, lisaftoclax, BGV-11417).
  • Has active human immunodeficiency virus (HIV) infection. HIV testing is not required unless required locally.
  • Recent history (within 6 months) of:
  • Congestive heart failure (defined as New York Heart Association, Class 2 or higher).
  • Ischemic cardiovascular event.
Show all 10Show fewer
  • Cardiac arrhythmia requiring pharmacological or surgical intervention.
  • Pericardial effusion.
  • Pericarditis.
  • Consumes known moderate or strong inhibitors of cytochrome P450 3A isoform subfamily (CYP3A) within 14 day or 5 half-lives of the drug (whichever is shorter) before the first dose of ABBV-453.

Trial locations and contacts

21 sites in 5 countries.

21 sites in 5 countries

United States6 sites

  • Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 264622

    Billings, Montana, 59102

  • Atrium Health Levine Cancer Institute /ID# 265136

    Charlotte, North Carolina, 28204

  • City of Hope /ID# 253904

    Duarte, California, 91010

  • Duplicate_Duke Cancer Center /ID# 258707

    Durham, North Carolina, 27710-3000

  • MD Anderson Cancer Center /ID# 253713

    Houston, Texas, 77030

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 267158

    Irvine, California, 92618

Other trials in United States

Germany5 sites

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 263433

    Berlin, 12203

  • Universitaetsklinikum Halle (Saale) /ID# 263299

    Halle, Saxony-Anhalt, 06120

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 263730

    Hamburg, 20246

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 263150

    Kiel, Schleswig-Holstein, 24105

  • Universitaetsklinikum Ulm /ID# 263148

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Australia4 sites

  • Austin Health /ID# 256776

    Heidelberg, Victoria, 3084

  • Royal Perth Hospital /ID# 256464

    Perth, Western Australia, 6000

  • Gold coast University Hospital /ID# 255785

    Southport, Queensland, 4215

  • Royal Prince Alfred Hospital /ID# 263129

    Sydney, New South Wales, 2050

Other trials in Australia

Israel3 sites

  • Hadassah Medical Center-Hebrew University /ID# 254721

    Jerusalem, Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 254383

    Ramat Gan, Tel Aviv, 5265601

  • Yitzhak Shamir Medical Center /ID# 257626

    Ẕerifin, Central District, 70300

Other trials in Israel

Italy3 sites

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 263065

    Bologna, 40138

  • IRCCS Ospedale San Raffaele /ID# 263064

    Milan, Milano, 20132

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 263062

    Perugia, 06156

Other trials in Italy

About this study

Official title: A Phase 1 Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-453 in Adult Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed.

ABBV-453 is an investigational drug for the treatment of CLL and SLL. Participants will be enrolled with a specific target dose and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. Approximately 60 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 40 sites across the world.

Read more

Participants will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. The estimated study duration is 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.

Being tested
Obinutuzumab, ABBV-453
Keywords
Chronic Lymphocytic Leukemia: Small Lymphocytic Lymphoma, SLL, CLL, ABBV-453
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObinutuzumabDrug

    Intravenous Infusion

  • ABBV-453Drug

    Oral; Tablet

Study groups in NCT06291220
Study groupRoleWhat they receive
Part A: Cohort 1.1 ABBV-453 Dose AExperimentalParticipants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose A is achieved, during the 5 year study duration.
Receives: Drug: Obinutuzumab; Drug: ABBV-453

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to 3 Years

  2. Maximum Administered Dose (MAD) of ABBV-453

    MAD is defined as the highest administered dose if no maximum tolerated dose (MTD) is determined.

    Measured: Up to 18 Months

  3. Maximum Tolerated Dose (MTD) of ABBV-453

    MTD is defined as the highest dose administered that does not result in a final determination of de-escalate at that dose level.

    Measured: Up to 18 Months

Secondary outcomes (10)

  1. Maximum Observed Plasma Concentration (Cmax) of ABBV-453

    Cmax is defined as the maximum observed plasma/serum concentration of ABBV-453.

    Measured: Up to 30 Months

  2. Time to Maximum Observed Concentration (Tmax) of ABBV-453

    Tmax is defined as the time to maximum observed concentration of ABBV-453.

    Measured: Up to 30 Months

  3. Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-453

    Area under the plasma/serum concentration versus time curve (AUC) of ABBV-453.

    Measured: Up to 30 Months

  4. Overall Response Rate (ORR)

    Percentage of participants achieving a complete response (CR), complete response with incomplete count recovery (CRi), partial response (PR), or nodular partial response (nPR) using disease-specific criteria per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL, 2018).

    Measured: Up to 3 Years

  5. Duration of Response (DOR) for Participants with PR/nPR or Better

    DOR is defined as the time between the initial PR or better response assessment per Investigator according to iwCLL criteria to the time of progressive disease (PD) or death of any cause, whichever occurs earlier.

    Measured: Up to 3 Years

  6. Complete response rate (CRR)

    CRR is defined as the percentage of participants with a best overall response (BOR) of CR or CRi per Investigator review according to iwCLL for participants with relapsed or refractory CLL/SLL, regardless of reasons for study drug discontinuation, and prior to start of subsequent anti-cancer therapies in the participants receiving at least one dose of ABBV-453 monotherapy.

    Measured: Up to 3 Years

  7. Duration of Complete Response (DOCR)

    DOCR is defined as the time between the initial CR/CRi response assessment per Investigator according to iwCLL criteria to the time of PD or death of any cause, whichever occurs earlier.

    Measured: Up to 3 Years

  8. Percentage of Participants Achieving an Minimal Residual Disease (MRD) Negativity Among Participants Achieving a PR, nPR, CR, or CRi

    MRD response is defined as < 1 cell in 10,000 leukocytes (< 10^-4).

    Measured: Up to 3 Years

  9. Progression-free survival (PFS)

    PFS is defined as time from first study treatment to a documented PD (based on iwCLL criteria) as determined by the Investigator, or death due to any cause, whichever occurs earlier.

    Measured: Up to 3 Years

  10. Overall survival (OS)

    OS is defined as the time from the first date of study treatment until date of death due to any cause.

    Measured: Up to 3 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start27 Jan 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06291220
Sponsor's protocol ID
M24-291
Other IDs
2023-507637-19, 2023-507637-19-00, 2023
Acronym
453 Ph1 CLL
Status last verified
Sep 2026
First submitted
27 Feb 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Obinutuzumab and ABBV-453 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by AbbVie at 21 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Germany, Australia, Israel, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs) (time frame: Up to 3 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06291220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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