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Prolymphocytic LeukemiaPhase 2NCT02662296

Ibrutinib or Idelalisib in Treating Patients With Persistent or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma After Donor Stem Cell Transplant

A Phase 2 study testing Ibrutinib and Idelalisib in people with Prolymphocytic Leukemia and Recurrent Chronic Lymphocytic Leukemia, run by Fred Hutchinson Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial studies how well ibrutinib or idelalisib works in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that is persistent or has returned (relapsed) after donor stem cell transplant. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ibrutinib and Idelalisib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Mar 2016to Feb 2022
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Patients with diagnoses of CLL/SLL or non-Hodgkin lymphoma (NHL) patients, who meet the criteria of either relapse or progression at any time point after allogeneic HCT or those who experience persistent stable disease or persistent disease with regression between days 28 and 100 post-transplant using standard morphologic, flow cytometric, and/or imaging studies and following the disease response evaluation criteria established by the International Workshop on CLL (IWCLL) for CLL and those following Cheson 2007 criteria for NHL
  • Patients will then be assigned to one of two cohorts:
  • Cohort 1 will include patients who have relapsed /progressed within the first 180 days post-transplant and who are still within 3 months from date of progression-relapse
  • Cohort 2 will include patients who have either i) relapsed/progressed beyond day 180 post-HCT, ii) those with persistent stable disease or persistent disease with regression between days 28-100 after allogeneic HCT, or iii) those who progressed or relapsed within 180 days after HCT but were not started on this protocol within 3 months from date of progression or relapse could also be enrolled under cohort 2
  • NOTE: the inclusion of patients with persistent stable or persistent regressing disease in this protocol is not meant to advocate treatment; however, if the attending physician is inclined to offer treatment then these patients would be eligible for this study
  • Patients must be able to give informed consent
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  • Women of childbearing potential and men who are sexually active must affirm they are practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials; men must agree to not donate sperm during or after the study; for females, these restrictions apply for 1 month after the last dose of study drug; for males, these restrictions apply for 3 months after the last dose of the study drug
  • Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [B-hCG]) or urine pregnancy test at screening
  • Absolute neutrophil count (ANC) >= 750/mm^3
  • Platelets >= 30,000/mm^3
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
  • Total bilirubin =< 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
  • Creatinine clearance (Clcr) > 25 mL/min

Who cannot join

  • Pregnant or breast feeding females; (lactating females must agree not to breast feed while taking ibrutinib or idelalisib)
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study should be first discussed and clarified with the study investigators
  • Concurrent use of other anti-cancer agents or treatments
  • Known history of human immunodeficiency virus (HIV)
  • Karnofsky performance status < 50%
  • Active grades III or IV acute GVHD
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  • Central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy
  • Vaccinated with live, attenuated vaccines within 4 weeks of initiation of therapy
  • Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol principal investigators
  • Unable to swallow capsules or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; malabsorption syndrome, resection of the small bowel, or poorly controlled inflammatory bowel disease affecting the small intestine
  • Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
  • Have uncontrolled hepatitis B or C infection
  • IBRUTINIB-SPECIFIC EXCLUSION CRITERIA
  • History of stroke or intracranial hemorrhage within 6 months of screening would be exclusion for ibrutinib therapy but idelalisib would be an option
  • Patients requiring anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 28 days from the start of study drug cannot be treated with ibrutinib but idelalisib would be an option
  • Patients requiring chronic treatment with strong cytochrome P450 family 3, subfamily A (CYP3A) inhibitors cannot be treated with ibrutinib but idelalisib would be an option
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification would be exclusion for ibrutinib therapy but idelalisib would be an option
  • IDELALISIB-SPECIFIC EXCLUSION CRITERIA
  • Ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension would be exclusion for idelalisib therapy but ibrutinib would be an option
  • Ongoing drug-induced pneumonitis would be exclusion for idelalisib therapy but ibrutinib would be an option

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase II, Non-Randomized, Single Institution, Clinical Trial of Signal Transduction Inhibitors, Ibrutinib or Idelalisib, to Treat Patients With Persistent or Relapsed B-Cell Malignancies Following Allogeneic Hematopoietic Cell Transplantation

This phase II trial studies how well ibrutinib or idelalisib works in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that is persistent or has returned (relapsed) after donor stem cell transplant. Ibrutinib and idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To improve the outcomes of patients who have progressed or relapsed lymphoma or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)/prolymphocytic leukemia (PLL) within 180 days following allogeneic hematopoietic cell transplant (HCT) compared to historical data: 12-month overall survival.

SECONDARY OBJECTIVES:

  1. To describe the safety profile observed in these populations.

II. Estimate the overall response rate (complete response [CR] + partial response [PR]) by standard morphologic, flow cytometric, imaging, and molecular techniques.

III. Assess progression free-survival.

IV. Define incidences of grade III-IV toxicities and infections.

  1. Estimate incidence of relapse and non-relapse mortality.

VI. Estimate incidences of grade II-III and III-IV acute graft-versus-host disease (GVHD) and chronic GVHD.

OUTLINE:

Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28 or idelalisib PO twice daily (BID) on days 1-28. Courses 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.

Being tested
Ibrutinib, Idelalisib
Medical subject headings
Leukemia, Prolymphocytic, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin

What participants receive

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

  • IbrutinibDrug

    Also called BTK Inhibitor PCI-32765, CRA-032765, PCI-32765

    Given PO

  • IdelalisibDrug

    Also called CAL-101, GS-1101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig

    Given PO

Study groups in NCT02662296
Study groupRoleWhat they receive
Treatment (ibrutinib or idelalisib)ExperimentalPatients receive ibrutinib PO QD on days 1-28 or idelalisib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Ibrutinib; Drug: Idelalisib

What is being measured

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

  1. Overall survival (OS) (Cohort I)

    OS will be estimated using the Kaplan-Meier method.

    Measured: 12 months

Secondary outcomes (3)

  1. Incidence of grade III-IV adverse events using the National Cancer Institute Common Toxicity Criteria version 4.0 (Cohort I and Cohort II)

    Toxicities among the 2 cohorts will be compared to those reported in the literature after using ibrutinib or idelalisib for relapsed CLL/lymphoma before transplant.

    Measured: Up to 30 days post-treatment

  2. OS (Cohort I and Cohort II)

    OS will be estimated using the Kaplan-Meier method in all cohorts.

    Measured: Up to 6 years

  3. Progression free-survival (PFS) (Cohort I and Cohort II)

    PFS will be estimated using the Kaplan-Meier method in all cohorts.

    Measured: Up to 6 years

Timeline

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

  1. First posted25 Jan 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionFeb 2022 (estimated)

Why it stopped: Low enrollment

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02662296
Sponsor's protocol ID
2561.00
Other IDs
NCI-2015-02201, 2561.00, P01CA018029, P30CA015704
Status last verified
Sep 2017
First submitted
20 Jan 2016
Last updated
27 Sep 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ibrutinib and Idelalisib in people with Prolymphocytic Leukemia and Recurrent Chronic Lymphocytic Leukemia, run by Fred Hutchinson Cancer Center at 1 site 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 13 inclusion and 20 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: withdrawn, as of the sponsor's last update on 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study was withdrawn before enrolling participants, so there are no results.

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 survival (OS) (Cohort I) (time frame: 12 months). 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 NCT02662296.

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 27 Sep 2017.

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