AzTrials
AzTrials

Recurrent Chronic Lymphocytic LeukemiaPhase 2NCT03961672

Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 2 study testing Duvelisib in people with Recurrent Chronic Lymphocytic Leukemia and Recurrent Small Lymphocytic Lymphoma, run by City of Hope Medical Center at 3 sites in United States.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This phase II trial studies how well duvelisib on an intermittent (irregular) dosing schedule works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Duvelisib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
3 sitesUnited States
Study dates
16 May 2020to 25 Oct 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Ability to understand and the willingness to sign a written informed consent document.
  • Histologically or flow cytometry confirmed diagnosis of B-CLL/small lymphocytic lymphoma (SLL) according to National Cancer Institute - Working Group (NCI-WG) 1996 guidelines. Patients who lack CD23 expression on their leukemia cells should be examined for (and found NOT to have) either t(11;14) or cyclin D1 overexpression, to rule out mantle cell lymphoma.
  • Participants have undergone >= 1 prior chemotherapy-based or immunotherapy-based regimen or targeted therapy (e.g., inhibitors of BTK [e.g., ibrutinib], or BCL2 [e.g., venetoclax]) administered for >= 2 cycles (>= 8 weeks for oral therapies), and have had either documented disease progression or no response (i.e., stable disease [SD]) to the most recent treatment regimen.
  • Note: Individuals intolerant to ibrutinib therapy and those who progress on ibrutinib are eligible as long as they satisfy the above criteria.
  • Patients with CLL/SLL must demonstrate active disease meeting at least 1 of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2018 criteria for requiring treatment:
  • A minimum of any one of the following constitutional symptoms:
Show all 26Show fewer
  • Unintentional weight loss > 10% within the previous 6 months prior to screening.
  • Extreme fatigue (unable to work or perform usual activities).
  • Fevers of greater than 100.5 degrees Fahrenheit (F) for >= 2 weeks without evidence of infection.
  • Night sweats without evidence of infection.
  • Evidence of progressive marrow failure as manifested by the development of, or worsening of anemia or thrombocytopenia.
  • Massive (i.e., > 6 cm below the left costal margin), progressive or symptomatic splenomegaly.
  • Massive nodes or clusters (i.e., > 10 cm in longest diameter) or progressive lymphadenopathy.
  • Progressive lymphocytosis with an increase of > 50% over a 2-month period, or an anticipated doubling time of less than 6 months.
  • Autoimmune anemia or thrombocytopenia that is poorly responsive to corticosteroids.
  • Symptomatic or functional extranodal involvement (eg, skin, kidney, lung, spine)
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
  • Direct bilirubin =< 2 x institutional upper limit of normal (ULN); unless due to known Gilbert's syndrome or compensated hemolysis directly attributable to CLL (prior to starting study drug).
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) less than 2.5 x institutional ULN (prior to starting study drug).
  • Estimated creatinine clearance (CrCL) using the Cockcroft-Gault equation (or an alternative equation, per institutional standard) >= 30 mL/min (prior to starting study drug).
  • Platelets >= 30,000/mm^3 independent of transfusion support, with no active bleeding, and absolute neutrophil count (ANC) >= 500/mm^3, unless due to disease involvement in the bone marrow (prior to starting study drug).
  • Participant must be able to swallow tablets or capsules. A participant with any gastrointestinal disease that would impair ability to swallow, retain, or absorb drug is not eligible.
  • Female participants of childbearing potential (defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months for women > 55 years of age) must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female participants of childbearing potential must agree to use adequate methods of contraception starting with the first dose of study therapy through 60 days after the last dose of study therapy.
  • Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year without an alternative medical cause.
  • Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 60 days after the last dose of study therapy.

Who cannot join

  • Prior therapeutic intervention with any of the following:
  • Therapeutic anticancer antibodies within 4 weeks;
  • Radio- or toxin-immunoconjugates within 10 weeks;
  • Inhibitors of Bruton tyrosine kinase (BTK) (e.g., ibrutinib), BH3-mimetic venetoclax, lenalidomide and other "targeted" therapy - within 6 half-lives (i.e., 36 hours for ibrutinib)
  • All other chemotherapy, radiation therapy within 3 weeks prior to initiation of therapy.
  • PI3K inhibitors (idelalisib, copanlisib or any investigational PI3K inhibitor including duvelisib and umbralisib) at any time.
Show all 26Show fewer
  • Any adverse event related to prior therapy that has not recovered to grade =< 1.
  • Chronic use of corticosteroids in excess of prednisone 30 mg/day or its equivalent.
  • Allogeneic stem cell transplant within the past 12 months, or ongoing immunosuppressive therapy other than prednisone =< 10 mg/day (or equivalent).
  • Use of strong CYP3A4 inhibitors or inducers, in the one week prior to initiating study treatment or concomitant.
  • Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (varicella zoster virus [VZV]) at screening.
  • History of prior malignancy except:
  • Malignancy treated with curative intent and no known active disease present for >= 2 years prior to initiation of therapy on current study;
  • Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease;
  • Adequately treated in situ carcinomas (e.g., breast, cervical, esophageal, etc.) without evidence of disease;
  • Asymptomatic prostate cancer managed with "watch and wait" strategy
  • Uncontrolled immune hemolysis or thrombocytopenia (positive direct antiglobulin test in absence of hemolysis or history of immune-mediated cytopenias are not exclusions).
  • History of human immunodeficiency virus (HIV) infection or active hepatitis B or C.
  • History of chronic liver disease.
  • Major surgery (requiring general anesthesia) within 2 weeks prior to initiation of therapy.
  • Patients with clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea, vomiting or any other condition that will interfere significantly with drug absorption.
  • History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening.
  • Baseline QT interval corrected with Fridericia's method (QTcF) > 500 ms. (NOTE: criterion does not apply to subjects with a right or left bundle branch block BBB).
  • Active uncontrolled infection.
  • Psychiatric illness/social situations that would limit compliance with study requirements.
  • Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • City of Hope Medical Center

    Duarte, California, 91010

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Phase II Study of Intermittent Duvelisib Dosing in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

This phase II trial studies how well duvelisib on an intermittent (irregular) dosing schedule works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving duvelisib on an intermittent schedule may result in similar effectiveness with less amount of severe side effects.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the efficacy of duvelisib (induction followed by maintenance [intermittent dosing]) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), as measured by the progression free survival (PFS).

SECONDARY OBJECTIVES:

  1. To evaluate safety of duvelisib induction and maintenance (by intermittent dosing) in relapsed/refractory CLL.

II. To evaluate clinical benefits to duvelisib treatment.

EXPLORATORY OBJECTIVE:

  1. To evaluate T-cell populations in patients with CLL treated with duvelisib.

OUTLINE:

INDUCTION: Patients receive duvelisib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for up to 12 months.

Being tested
Duvelisib
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.

  • DuvelisibDrug

    Also called 8-Chloro-2-phenyl-3-((1S)-1-(7H-purin-6-ylamino)ethyl)isoquinolin-1(2H)-one, Copiktra, INK-1197, IPI-145

    Given PO

Study groups in NCT03961672
Study groupRoleWhat they receive
Treatment (duvelisib)ExperimentalINDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Duvelisib

What is being measured

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

  1. Progression Free Survival (PFS) at 12 Months

    Progression is defined using IWCLL 2018 guidelines (Section 5.3 of Hallek et al, 2018). Proportion of subjects achieving 12-month PFS were estimated along with a two-sided exact Clopper-Pearson 95% confidence interval. PFS was estimated from start of duvelisib treatment until death, time of progression, start of new therapy, or end of follow-up, whichever occurs first. PFS was censored at the start of new therapy or end of follow-up, whichever occurs first.

    Measured: First dose of duvelisib until death, time of progression, start of new therapy, or 12 months from start of therapy, whichever occurs first

Secondary outcomes (5)

  1. Objective Response Rate (ORR) (Including Complete Response [CR] and Partial Response [PR])

    Treatment responses were defined by using IWCLL 2018 guidelines (Hallek et al, 2018). Overall Response (OR) = CR + PR. Probability of having ORR was measured and reported with 95% exact confidence interval.

    Measured: First dose of duvelisib up to 12 months after discontinuation of duvelisib

  2. Median Progression-Free Survival (PFS)

    Progression is defined using IWCLL 2018 guidelines (Section 5.3 of Hallek et al, 2018). Estimated distribution of the PFS was plotted using Kaplan Meier curves and reported with median PFS and 95% confidence intervals.

    Measured: First dose of duvelisib until death, time of progression, or start of new therapy, whichever occurs first, assessed up to 12 months after discontinuation of duvelisib

  3. Percentage of the Participants With 12-month Duration of Response (DOR)

    Duration of response (DOR), for participants who responded to the study intervention, was measured from the time of first documented objective response (i.e., CR or PR/PR-L) until evidence of progressive disease, start of new therapy, death, or end of follow-up. DOR was censored at the start of new therapy or end of follow-up, whichever occurs first. Proportion of the participants achieving 12-month DOR and the 95% confidence interval were reported.

    Measured: From time of ORR until death, time of progression, start of new therapy, or end of follow-up, whichever occurs first, assessed up to 12 months after discontinuation of duvelisib

  4. Percentage of Participants With Grade 3 4 5 Toxicity Related to Duvelisib

    Percentage of participants, that received at least one dose of duvelisib, had developed grade 3 4 5 toxicities at least possibly related to duvelisib. The 95% confidence interval was calculated by the Clopper-Pearson (exact) method.

    Measured: From first dose of duvelisib until 3 months post-discontinuation of duvelisib

  5. Number of Administrated Cycles of the Study Treatment

    Number of study treatment cycles that participants received from the first dose of study drug until therapy was discontinued for any reason.

    Measured: From first dose of duvelisib until time of duvelisib discontinuation up to 5 years.

Timeline

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

  1. First posted23 May 2019
  2. Study start16 May 2020
  3. Primary completion31 Jul 2023
  4. Study completion25 Oct 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03961672
Sponsor's protocol ID
19563
Other IDs
NCI-2019-02789, HEM-19009-LM, 19563 (City of Hope), STUDY00019402, P30CA033572
Status last verified
Oct 2026
First submitted
14 May 2019
Last updated
2 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shouse G, Chen L, Siddiqi T, Muir A, Brown JR, Spurgeon SE, Danilov AV. A phase II study of induction followed by intermittent duvelisib dosing in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Leuk Lymphoma. 2024 Oct;65(10):1516-1519. doi: 10.1080/10428194.2024.2361841. Epub 2024 Jun 5. No abstract available.

    PubMed 38836342

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Duvelisib in people with Recurrent Chronic Lymphocytic Leukemia and Recurrent Small Lymphocytic Lymphoma, run by City of Hope Medical Center at 3 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 26 inclusion and 26 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (PFS) at 12 Months (time frame: First dose of duvelisib until death, time of progression, start of new therapy, or 12 months from start of therapy, whichever occurs first). 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 NCT03961672, which also lists 1 linked publication.

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 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in