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Lymphoma, Mantle- CellPhase 2PILLAR-1NCT00702052

Safety and Efficacy of RAD001 in Participants With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy

A Phase 2 study testing Everolimus in people with Lymphoma, Mantle- Cell, run by Novartis Pharmaceuticals at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in participants with Mantle Cell Lymphoma who were refractory or intolerant to Velcade® therapy and who had received at least one prior antineoplastic agent other than Velcade®, either separately or in combination with Velcade®… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Lymphoma, Mantle- Cell
What is being tested?
Everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
31 sitesUnited States
Study dates
22 Aug 2008to 20 Apr 2012
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants (≥18 years old) with Mantle Cell Lymphoma that has been confirmed by central pathology review (archival diagnostic tumor specimen required).
  • Participants with mantle cell lymphoma who have documented refractory disease to Velcade® (bortezomib) or who have documented intolerance to Velcade® therapy. Intolerance to Velcade® is determined by the study investigator based on clinical evaluations. Participants are considered refractory to Velcade® if they have documented radiological progression on or within 12 months of last dose of Velcade® when given alone or, on or within 12 months from the last dose of the last component of a combination therapy which included Velcade®. Participants are considered refractory to Velcade®, if Velcade® is part of a combination treatment for the disease.
  • Participants must have received at least one prior antineoplastic agent, other than Velcade® either separately or in combination with Velcade® (bortezomib).
  • At least one site of measurable nodal disease at baseline >2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by computer tomography (CT) scan (or magnetic resonance imaging (MRI), only if CT scan can not be performed).
  • Eastern Cooperative Oncology Group (ECOG) performance status = 0, 1 or 2.
  • Life expectancy ≥3 months.
  • Adequate bone marrow, liver and renal function.
  • Platelets ≥75 x 10^9/L (untransfused platelets).

Who cannot join

  • Participants who are currently receiving anticancer therapies or have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation, antibodies, targeted therapy etc.) are not eligible.
  • Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (e.g. everolimus, sirolimus, temsirolimus, etc).
  • Participants with prior allogeneic stem cell transplant.
  • Grade 3 or 4 unresolved toxicity from prior antineoplastic therapies.
  • Currently taking other investigational agents or received other investigational drugs within 4 weeks of the start of study drug.
  • Participants with central nervous system (CNS) lymphoma are not eligible; head magnetic resonance imaging (MRI) (or computer tomography (CT) if MRI is not available) is required prior to study entry.
Show all 12Show fewer
  • Use of chronic, systemic corticosteroids or another immunosuppressive agent, except prednisone ≤20 mg daily (or equivalent) for adrenal insufficiency (must have been on a stable dosage regimen for ≥4 weeks prior to the first treatment with RAD001).
  • HIV positive participants are not eligible; (human immunodeficiency virus (HIV) testing is not required for study entry; review of previous medical records is required).
  • Uncontrolled hyperlipidemia (≥Grade 3 hyperlipidemia despite optimal supportive medical therapy).
  • Active, bleeding disorders or major surgery within 4 weeks of starting study drug.
  • Severe and/or uncontrolled medical conditions such as symptomatic congestive heart failure (New York Heart Association Class III or IV), unstable angina, myocardial infarction within 6 months or study start, severely impaired lung function, cirrhosis, chronic active/persistent hepatitis.
  • History of another primary malignancy ≤3 years prior to study entry.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • University of Michigan Comprehensive Cancer Center Dept of Michigan Cancer Center

    Ann Arbor, Michigan, 48109-0944

  • Georgia Health Sciences University Dept. of MCG

    Augusta, Georgia, 30912

  • St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)

    Beech Grove, Indiana, 46107

  • Northwestern University

    Chicago, Illinois, 60611

  • Bay Area Cancer Research Dept.ofBayAreaCancerResearch

    Concord, California, 94520

  • Baylor College of Medicine Dept. of Sammons Cancer (2)

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(2)

    Dallas, Texas, 75390-8527

  • City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)

    Duarte, California, 91010-3000

  • Highlands Oncology Group DeptofHighlandsOncologyGrp(2)

    Fayetteville, Arkansas, 72703

  • East Carolina University BrodySchool of Medicine

    Greenville, North Carolina, 27858

  • Cancer Centers of the Carolinas CC of C -Eastside

    Greenville, South Carolina, 29605

  • Rocky Mountain Cancer Centers RMCC - Denver-Midtown

    Greenwood Village, Colorado, 80121

  • Hackensack University Medical Center Dept ofHackensackUniversityMC

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (10)

    Houston, Texas, 77030-4009

  • Central Indiana Cancer Centers CICC - East (2)

    Indianapolis, Indiana, 46227

  • UCLA/ University of California Los Angeles Dept.of Hem/Oncology

    Los Angeles, California, 90095

  • Advanced Medical Specialties Medical Onc Hem

    Miami, Florida, 33176

  • West Virginia University/ Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26506

  • Mayo Clinic - Arizona Mayo Clinic - Scottsdale

    Multiple Locations, Arizona, 85259

  • Vanderbilt University Medical Center, Clinical Trials Center Dept. of VUMC

    Nashville, Tennessee, 37212

  • New York University Medical Center NYU Cancer Institute

    New York, New York, 10016

  • Fox Chase Cancer Center Regulatory Contact

    Philadelphia, Pennsylvania, 19111-2497

  • Western Pennsylvania Cancer Institute /Western Penn Hospital Western Pann. Cancer Inst.

    Pittsburgh, Pennsylvania, 15224

  • University of Pittsburgh Medical Center Hillman Cancer Center (4)

    Pittsburgh, Pennsylvania, 15232

  • Northwest Cancer Specialists Vancouver Cancer Center (2)

    Portland, Oregon, 97210

  • Kaiser Permanente Northwest Dept of Kaiser Northwest (3)

    Portland, Oregon, 97227

  • Mayo Clinic - Rochester Hematology

    Rochester, Minnesota, 55905

  • University of California Davis Cancer Center Dept. of UC Davis Cancer (4)

    Sacramento, California, 95817

  • Cancer Care Northwest CC Northwest- Spokane South(3)

    Spokane, Washington, 99202

  • Washington University School Of Medicine-Siteman Cancer Ctr Medical Oncology

    St Louis, Missouri, 63110

  • Tyler Cancer Center Dept.ofTylerCancerCtr.

    Tyler, Texas, 75702

Other trials in United States

About this study

Official title: An Open-Label, Single-Arm, Phase II Study of RAD001 in Patients With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® (Bortezomib)

This study was to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in participants with Mantle Cell Lymphoma who were refractory or intolerant to Velcade® therapy and who had received at least one prior antineoplastic agent other than Velcade®, either separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade® therapy was determined by the study investigator based on clinical evaluations. Participants were considered refractory to Velcade® if they have documented radiological progression on or within 12 months of the last dose of Velcade® when given alone or, on or within 12 months of the last dose of the last component of a combination therapy which included Velcade®.

Being tested
Everolimus
Keywords
Mantle Cell Lymphoma, Lymphoma, B-Cell Lymphoma, Mantle Zone Lymphoma, Refractory Lymphoma, Aggressive Lymphoma, PILLAR-1
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma, Lymphoma, B-Cell

What participants receive

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

  • EverolimusDrug

    Also called RAD001

    Everolimus tablets

Study groups in NCT00702052
Study groupRoleWhat they receive
EverolimusExperimentalParticipants received everolimus tablets, 10 mg, orally, once daily during each 28 day cycle until determination of objective tumor progression or unacceptable toxicity, or death, or consent withdrawal, or discontinuation from the study for any other reason.
Receives: Drug: Everolimus

What is being measured

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

  1. Overall Response Rate (ORR)

    Overall response rate was defined as the percentage of participants with a best overall disease response of complete response (CR) or partial response (PR). CR was defined as complete disappearance of all extranodal lesions. PR was defined as at least a 50% decrease in the sum of the product of diameter (SPD) of all index nodal and extranodal lesions.

    Measured: From date of enrollment up to disease progression or death (approximately 3.8 years)

Secondary outcomes (5)

  1. Disease Control Rate (DCR)

    Disease Control Rate was defined as the percentage of participants with best overall disease response of CR or PR or stable disease (SD). CR was defined as complete disappearance of all extranodal lesions. PR was defined as at least a 50% decrease in SPD of all index nodal and extranodal lesions. SD was defined failure to attain the criteria needed for CR or PR and failure to fulfill the criteria for at least a 50% increase in the SPD of all index nodal and extranodal (including splenic and/or hepatic nodules) lesions, taking as reference the smallest sum of the product of the diameters of all index lesions recorded at or after baseline.

    Measured: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)

  2. Duration of Response

    Duration of response was defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to lymphoma. CR was defined as complete disappearance of all extranodal lesions. PR was defined as at least a 50% decrease in SPD of all index nodal and extranodal lesions.

    Measured: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)

  3. Progression Free Survival (PFS)

    PFS was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause.

    Measured: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)

  4. Overall Survival

    Overall survival was defined as the time from the date of start of study treatment to the date of death due to any cause.

    Measured: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)

  5. Number of Participants With At Least One Adverse Event (AE) and Serious Adverse Event (SAE)

    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.

    Measured: From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)

Timeline

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

  1. First posted20 Jun 2008 (estimated)
  2. Study start22 Aug 2008
  3. Primary completion20 Apr 2012
  4. Study completion20 Apr 2012

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
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00702052
Sponsor's protocol ID
CRAD001N2201
Other IDs
2007-005700-40
Acronym
PILLAR-1
Status last verified
Apr 2021
First submitted
19 Jun 2008
Last updated
25 May 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Everolimus in people with Lymphoma, Mantle- Cell, run by Novartis Pharmaceuticals at 31 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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 25 May 2021). 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?

Overall Response Rate (ORR) (time frame: From date of enrollment up to disease progression or death (approximately 3.8 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 NCT00702052.

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 25 May 2021.

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