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New hope for Tough-to-Treat blood cancers: targeted pill shows promise

NCT ID NCT02966756

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This phase 2 trial tests the drug venetoclax (a pill) in 110 people with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study includes two groups: those with a specific genetic change (17p deletion) and those who have failed other targeted therapies. The main goal is to see how many people respond to the treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
venetoclax (a targeted cancer pill)
What this could lead to
If successful, this could provide a new treatment option for people with hard-to-treat CLL or SLL.
What could go wrong
This is an early-phase trial with no placebo group, so results may not confirm real-world benefit. Side effects like tumor lysis syndrome or infections are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

66 people

The number who actually took part.

Started

Oct 2017

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant must have a diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that meets 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) National Cancer Institute-Working Group (NCI-WG) Guidelines and the following: * Participant must have an indication for treatment according to the 2008 Modified iwCLL NCI-WG Guidelines. * SLL participant must have measurable disease (B-lymphocytosis greater than 5 × 10\^9/L or an enlarged lymph node(s) (Longest Diameter (LDi) \> 1.5 cm at baseline) or hepatomegaly or splenomegaly due to CLL). * SLL participant must have presence of lymphadenopathy and absence of cytopenias caused by a clonal marrow infiltrate. * Participant must have relapsed or refractory CLL/SLL after receiving at least one prior line of therapy. * Participants (in Cohort 1) must have 17p deletion, assessed by a central laboratory. * Participants (in Cohort 2) must meet both of the following: * Relapsed/refractory disease to B-Cell Receptor Signaling Pathway Inhibitor (BCRI) treatment; * And either of the following: (a) relapsed/refractory disease to chemoimmunotherapy (CIT), or (b) ineligible to receive CIT, defined as having known 17p deletion or TP53 mutation, or Cumulative Illness Rating Scale (CIRS) \>6 or calculated creatinine clearance \<70 mL/min, or participants in whom the investigator evaluated that the use of CIT was inappropriate. * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2. * Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory reference range at Screening. * No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Exclusion Criteria: * Participant has undergone an allogeneic stem cell transplant. * Participant has developed Richter's transformation confirmed by biopsy. * Participant has prolymphocytic leukemia. * Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to screening), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP). * Participant has previously received venetoclax or other BCL-2 inhibitors. * Participant is known to be positive for Human Immunodeficiency Virus (HIV). * Participant has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug. * Participant has received any of the following within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of venetoclax, or has not recovered to less than Common Toxicity Criteria for Adverse Events (CTCAE) grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy: * Any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy or targeted small molecule agents. * Investigational therapy, including targeted small molecule agents. * Participant has known allergy to both xanthine oxidase inhibitors and rasburicase.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chromosome 17p deletion leukemia lymphoproliferative syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia (CLL) Small lymphocytic lymphoma (SLL)

Contacts and locations

Locations

  • Anhui Provincial Cancer Hospital /ID# 209458

    Hefei, Anhui, 230031, China

  • Changhua Christian Hospital /ID# 202768

    Changhua City, Changhua County, 50006, Taiwan

  • China Medical University Hospital /ID# 202767

    Taichung, 40447, Taiwan

  • Christchurch Hospital. /ID# 201650

    Christchurch, Canterbury, 8011, New Zealand

  • Concord Repatriation General Hospital /ID# 201261

    Concord, New South Wales, 2139, Australia

  • Fujian Medical University Union Hospital /ID# 156579

    Fuzhou, Fujian, 350001, China

  • Guangdong Provincial Peoples Hospital /ID# 160509

    Guangzhou, Guangdong, 510080, China

  • Henan Cancer Hospital /ID# 156573

    Zhengzhou, Henan, 450008, China

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 157762

    Tianjin, Tianjin Municipality, 300020, China

  • Jiangsu Province Hospital /ID# 156577

    Nanjing, Jiangsu, 210029, China

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 202765

    Kaohsiung City, 807, Taiwan

  • Linkou Chang Gung Memorial Hospital /ID# 203636

    Taoyuan City, 333, Taiwan

  • Monash Health - Monash Medical Centre - Clayton /ID# 201263

    Clayton, Victoria, 3168, Australia

  • Nanfang Hospital of Southern Medical University /ID# 156571

    Guangzhou, Guangdong, 510515, China

  • National Taiwan University Hospital /ID# 210733

    Taipei, 100, Taiwan

  • North Shore Hospital /ID# 204637

    Takapuna, Auckland, 0622, New Zealand

  • Peking Union Medical College Hospital East - Dongdan Campus /ID# 156576

    Beijing, Beijing Municipality, 100730, China

  • Peking University People's Hospital /ID# 156575

    Beijing, Beijing Municipality, 100044, China

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 156572

    Shanghai, Shanghai Municipality, 200065, China

  • Shandong Provincial Hospital /ID# 156574

    Jinan, Shandong, 250021, China

  • St George Hospital - Kogarah /ID# 206484

    Kogarah, New South Wales, 2217, Australia

  • The First Affiliated Hospital of Nanchang University /ID# 159142

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Soochow University /ID# 156536

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 156578

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jilin University /ID# 156532

    Changchun, Jilin, 130021, China

  • The General Hospital of Western Theater Command PLA /ID# 159145

    Chengdu, Sichuan, 610083, China

  • The Second Hospital of Hebei Medical University /ID# 159143

    Shijiazhuang, Hebei, 050000, China

  • Tianjin Medical University Cancer Institute & Hospital /ID# 156542

    Tianjin, Tianjin Municipality, 300060, China

  • Tongji Hospital Tongji Medical College of HUST /ID# 156589

    Wuhan, Hubei, 430030, China

  • West China Hospital, Sichuan University /ID# 156537

    Chengdu, Sichuan, 610041, China

  • Xiangya Hospital Central South University /ID# 208913

    Changsha, Hunan, 410008, China

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