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Chronic Lymphocytic LeukemiaPhase 2NCT03467867

A Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL

A Phase 2 study testing Venetoclax, Rituximab and Rituximab/Hyaluronidase Human in people with Chronic Lymphocytic Leukemia, run by Georgetown University at 2 sites in United States.

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

This is an open-label, multicenter, Phase II study to investigate the efficacy and safety of venetoclax in combination with Rituximab/hyaluronidase human in participants with relapsed or refractory chronic lymphocytic leukemia (CLL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Venetoclax, Rituximab and Rituximab/Hyaluronidase Human
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesUnited States
Study dates
26 Apr 2018to Dec 2026
Phase
Phase 2
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

  • Signed Informed Consent Form
  • Ability and willingness to comply with the requirements of the study protocol
  • Patient must have diagnosis of CLL that meets published 2008 IWCLL NCI-WG criteria.
  • Patient must have relapsed/refractory disease with an indication for treatment.
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2
  • Adequate hematologic function (unless caused by underlying disease, as established by extensive bone marrow involvement or as a result of hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator) defined as follows:
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  • Hemoglobin (> / =) 9 g/dL
  • Absolute neutrophil count (> / =) 1.0 x 109/L
  • Platelet count (> / =)75 x 109/L
  • Adequate renal function, as indicated by:
  • Calculated creatinine clearance ≥ 30 mL/min using 24-hour Creatinine Clearance or modified Cockcroft-Gault equation (eCCR; with the use of ideal body mass [IBM] instead of mass)
  • Adequate liver function, as indicated by:
  • AST or ALT (< / =) 2.5 x ULN
  • Total bilirubin < 1.5 x ULN (or (< / =) 3 x ULN for patients with documented Gilbert syndrome)
  • Female patients who are not of child-bearing potential and female patients of child-bearing potential who have a negative serum pregnancy test within 3 days prior to Cycle 1, Day 1.
  • Patients with HIV infection could be included in the study, as long as their disease is under control on anti-retroviral therapy. Precautions should be taken to modify their HAART regimen to minimize drug interaction
  • Warfarin is considered a cautionary medication. Patients on warfarin will be encouraged to replace warfarin with other anticoagulants if possible. If it is not possible or patient is not willing to switch, they could still be included in the study with caution.

Who cannot join

  • Known hypersensitivity to any of the study drugs
  • Allogeneic stem cell transplant within the past 1 year.
  • Richter's transformation confirmed by biopsy
  • History of other malignancy that could affect compliance with the protocol or interpretation of results
  • Patients with a history of curatively treated basal or squamous cell carcinoma or Stage 1 melanoma of the skin or in situ carcinoma of the cervix are eligible.
  • Patients with a malignancy that has been treated with surgery alone with curative intent will be included. Individuals in documented remission without treatment for (> / =) 2 years prior to enrollment may be included at the discretion of the investigator.
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  • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the patient, including renal disease that would preclude chemotherapy administration or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
  • Received the following agents within 7 days prior to the first dose of venetoclax:
  • Steroid therapy for anti-neoplastic intent
  • Strong and moderate CYP3A inhibitors
  • Strong and moderate CYP3A inducers
  • Consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of venetoclax
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody
  • Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation
  • Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to undergo monthly DNA testing.
  • Known infection with human T-cell leukemia virus 1 (HTLV-1)
  • Patients with uncontrolled HIV infection
  • Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment
  • Pregnant or lactating, or intending to become pregnant during the study Women of childbearing potential must have a negative serum pregnancy test result within 21 days prior to initiation of study drug.
  • Recent major surgery (within 6 weeks prior to the start of Cycle 1, Day 1) other than for diagnosis
  • Malabsorption syndrome or other condition that precludes enteral route of administration
  • Known allergy to both xanthine oxidase inhibitors and rasburicase

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase II Study of Venetoclax and Rituximab/Hyaluronidase Human in Relapsed/Refractory CLL

This is an open-label, multicenter, Phase II study to investigate the efficacy and safety of venetoclax in combination with Rituximab/hyaluronidase human in participants with relapsed or refractory chronic lymphocytic leukemia (CLL).

Read the detailed description

The study has one arm and all the patients will receive venetoclax and rituximab.

Being tested
Venetoclax, Rituximab, Rituximab/Hyaluronidase Human
Keywords
Chronic Lymphocytic Leukemia, Leukemia, Venetoclax, Rituximab, Lymphoid, Lymphoproliferative Disorders, Antineoplastic Agents, Neoplasm
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Lymphoproliferative Disorders, Neoplasms

What participants receive

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

  • VenetoclaxDrug

    Also called GDC-0199, ABT-199

    Venetoclax will be administered as described in the reporting arm.

  • RituximabDrug

    Also called Rituxan

    Rituximab (IV) will be administered as described in the reporting arm.

  • Rituximab/Hyaluronidase HumanDrug

    Also called Rituxan Hycela

    Rituximab/Hyaluronidase Human (SC) ill be administered as described in the reporting arm.

Study groups in NCT03467867
Study groupRoleWhat they receive
Venetoclax + RituximabExperimentalParticipants will be initially placed in a venetoclax 5 weeks ramp-up period, and will be administered an initial 20 mg oral tablet dose once daily (QD), incrementing weekly up to a maximum dose of 400 mg. Participants will then continue taking venetoclax 400 mg QD from Week 5 onwards, as directed by the investigator in combination with rituximab 375 mg/m^2 IV on Day 1 of Cycle 1 followed by 13.4 mL of rituximab SC 1,600 mg/26,800 Units vial (1,600 mg rituximab and 26,800 Units hyaluronidase human) on Day 1 of Cycle 2-6.
Receives: Drug: Venetoclax; Drug: Rituximab; Drug: Rituximab/Hyaluronidase Human

What is being measured

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

  1. Overall Response Rate (ORR)

    Percentage of Participants With Best Overall Response (OR)(Defined as Complete Response [CR], Initial CR [CRi], Nodular Partial Response [nPR], PR) as Assessed by Investigator Determined Using iwCLL Guidelines

    Measured: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)

Secondary outcomes (7)

  1. Disease Response

    Percentage of Participants With Disease Response (OR, CR, CRi, nPR, PR) as Assessed by Investigator Determined Using iwCLL Guidelines at end of Combination Treatment Visit

    Measured: 12 weeks after Day 1 of last cycle of combination therapy (approximately 5 years, cycle length= 28 days)

  2. Duration of Responses (DOR)

    Duration of Responses (DOR)

    Measured: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)

  3. Time to Progression (TTP)

    Time to progression will be defined as the time from the date of first dose (date of enrollment if not dosed) to the date of earliest disease progression (per the investigator assessment).

    Measured: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)

  4. Progression-Free Survival (PFS)

    Investigator-Assessed Progression-Free Survival (PFS) Determined Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines

    Measured: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years) ]

  5. Overall Survival (OS)

    Overall Survival (OS)

    Measured: Baseline up to death (up to approximately 5 years)

  6. Time to Next Anti-CLL Treatment (TTNT)

    Time to Next Anti-CLL Treatment (TTNT)

    Measured: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years) ]

  7. Percentage of Participants With Minimal Residual Disease (MRD)

    Percentage of Participants With Minimal Residual Disease (MRD) Negativity at End of Combination Treatment Response Visit

    Measured: 12 weeks after Day 1 of last cycle of combination therapy (up to approximately 5 years, cycle length= 28 days) ]

Timeline

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

  1. First posted16 Mar 2018
  2. Study start26 Apr 2018
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03467867
Sponsor's protocol ID
2017-1502
Status last verified
Apr 2026
First submitted
12 Mar 2018
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venetoclax, Rituximab and Rituximab/Hyaluronidase Human in people with Chronic Lymphocytic Leukemia, run by Georgetown University at 2 sites in United States.

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 17 inclusion and 24 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Overall Response Rate (ORR) (time frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)). 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 NCT03467867.

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 6 Apr 2026.

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