LeukemiaPhase 2NCT00185731
Phase 2 Study of Atorvastatin Safety and Antitumor Effects in Non-Hodgkin's Lymphoma
A Phase 2 study testing Atorvastatin in people with Leukemia and Lymphoma, Non-Hodgkin, run by Dean Felsher at 1 site in United States.
Trial summary
This is an approach which can inflict significant toxicity. An alternative is to block expression of oncogenes which are over-expressed only in cancer cells, a therapeutic approach which could reduce toxicity to the host while maximizing destruction of the oncogene-dependent malignant cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphoma, Non-Hodgkin
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old
- Disease criteria: Confirmed by Stanford Pathology to be one of the following Non-Hodgkin's Lymphoma (NHL) subtypes:
- Chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL)
- Extranodal marginal zone B-cell lymphoma
- Nodal marginal zone B-cell lymphoma
- Splenic marginal zone B-cell lymphoma
Show all 32Show fewer
- Treatment criteria
- Untreated: watchful waiting currently appropriate (includes CLL stage 0) o OR
- Prior treatment: watchful waiting currently appropriate o OR
- Refractory disease
- Staging within 4 weeks prior to enrollment (SLL, marginal zone lymphoma)
- CT chest (date)
- CT abdomen (date)
- CT pelvis (date) OR
- Staging within 4 weeks prior to enrollment (CLL: CT not required)
- Total white blood cell count (WBC) (Value) (date)
- Absolute lymphoma cell count (ALC) (Value) (date)
- Measurable disease (Site) (Size) OR
- CLL (only): elevated absolute lymphoma cell count
- Disease amenable to biopsy (must check at least one):
- Circulating tumor cells
- Positive bone marrow
- Palpable involved site (such as lymph node) measuring > 1.5 cm
- Eastern Cooperative Oncology Group performance status <2 (Karnofsky >60)
- Life expectancy of greater than 3 months
- Patients must have adequate organ and marrow function
- Absolute neutrophil count > 1,000/uL
- Platelets > 30,000/uL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ratio < 2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of child-bearing potential must have negative BetaHCG at enrollment
Who cannot join
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Not recovered from adverse events due to agents administered more than four weeks earlier
- Has stable low grade lymphoma has had rituximab within 3 months Patient with relapsed or refractory disease has had rituximab within 1 month
- Not recovered from adverse events due to surgery performed 4 weeks earlier
- Receiving any other investigational agent. Known brain metastases
- Taken any statin within the past 6 months prior to enrollment in the trial
Show all 11Show fewer
- Currently abuses alcohol
- Currently takes cyclosporin or gemfibrozil Patient has a prior history of rhabdomyolysis
- Has uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant: Patients are not excluded if they are breastfeeding at the time of enrollment, but breastfeeding should be discontinued if the mother is treated with atorvastatin.
- HIV-positive patients receiving combination anti-retroviral therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma
This is an approach which can inflict significant toxicity. An alternative is to block expression of oncogenes which are over-expressed only in cancer cells, a therapeutic approach which could reduce toxicity to the host while maximizing destruction of the oncogene-dependent malignant cells.
Read the detailed description
Atorvastatin has been shown to decrease levels of active oncogenes in preclinical studies with murine and human lymphoma cell lines, and administration of statins leads to shrinkage of lymphoma in murine models. Therefore, it may be possible for atorvastatin to decrease levels of active oncogenes in human lymphomas. Further, upon decrease in levels of active oncogenes, human lymphomas may regress. Atorvastatin is a commonly prescribed drug for hypercholesterolemia: targeting the 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase enzyme may also be a way to decrease activation of oncogenes in human lymphoma, with minimal toxicity. For human low grade non-Hodgkin lymphoma, no curative treatment is available; therefore new, non-toxic and targeted therapies are sought for this disease.
- Conditions
- Leukemia, Lymphoma, Non-Hodgkin
- Being tested
- Atorvastatin
- Medical subject headings
- Leukemia, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
80 mg orally once daily
| Study group | Role | What they receive |
|---|---|---|
| 80 mg Atorvastatin | Experimental | Atorvastatin, 80 mg tablet, will be taken orally by the patient daily, beginning on study day 1. Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Apoptosis
Expressed as the number of participants whose tumor cells showed an increase in apoptosis during atorvastatin treatment
Measured: 1 year
Secondary outcomes (2)
Correlation of Tumor Apoptosis to Clinical Response
The validity of tumor apoptosis as a biologic endpoint was assessed by correlation to clinical response. A correlation substantially less than 1 is interpreted as a poor correlation, while a correlation near +1 or -1 is interpreted as a strong correlation.
Measured: 1 year
Atorvastatin Toxicity
Assessed as the number of study participants with atorvastatin-related serious adverse events (SAEs).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Dean Felsher
- Sponsor type
- University, hospital or other
- Collaborators
- The Leukemia and Lymphoma Society, Damon Runyon Cancer Research Foundation, Burroughs Wellcome
- Responsible party
- Sponsor-investigator, Dean Felsher, Stanford University
- Investigators
- Dean Felsher, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185731
- Sponsor's protocol ID
- IRB-13683
- Other IDs
- 4328-07, 95140, LYMNHL0020
- Status last verified
- Oct 2017
- First submitted
- 12 Sep 2005
- Last updated
- 2 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Atorvastatin in Patients With Low Grade or Refractory Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00185731
- Acronym / sponsor ID
- IRB-13683
- Conditions
- Leukemia, Lymphoma, Non-Hodgkin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dean FelsherUniversity, hospital or other
- Collaborators
- The Leukemia and Lymphoma Society, Damon Runyon Cancer Research Foundation, Burroughs Wellcome
- Study start
- Apr 2005
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 2 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an approach which can inflict significant toxicity. An alternative is to block expression of oncogenes which are over-expressed only in cancer cells, a therapeutic approach which could reduce toxicity to the host while maximizing destruction of the oncogene-dependent malignant cells.
Detailed description
Atorvastatin has been shown to decrease levels of active oncogenes in preclinical studies with murine and human lymphoma cell lines, and administration of statins leads to shrinkage of lymphoma in murine models. Therefore, it may be possible for atorvastatin to decrease levels of active oncogenes in human lymphomas. Further, upon decrease in levels of active oncogenes, human lymphomas may regress. Atorvastatin is a commonly prescribed drug for hypercholesterolemia: targeting the 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase enzyme may also be a way to decrease activation of oncogenes in human lymphoma, with minimal toxicity. For human low grade non-Hodgkin lymphoma, no curative treatment is available; therefore new, non-toxic and targeted therapies are sought for this disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 80 mg Atorvastatin | Experimental | Drug: AtorvastatinAtorvastatin, 80 mg tablet, will be taken orally by the patient daily, beginning on study day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- > 18 years old
- Disease criteria: Confirmed by Stanford Pathology to be one of the following Non-Hodgkin's Lymphoma (NHL) subtypes:
- Treatment criteria
- Staging within 4 weeks prior to enrollment (SLL, marginal zone lymphoma)
- Staging within 4 weeks prior to enrollment (CLL: CT not required)
Key exclusion criteria (11 listed)
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Not recovered from adverse events due to agents administered more than four weeks earlier
- Has stable low grade lymphoma has had rituximab within 3 months Patient with relapsed or refractory disease has had rituximab within 1 month
- Not recovered from adverse events due to surgery performed 4 weeks earlier
- Receiving any other investigational agent. Known brain metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor80 mg orally once daily | Drug | 80 mg Atorvastatin |
Primary outcome
Tumor Apoptosis
Time frame: 1 year
Expressed as the number of participants whose tumor cells showed an increase in apoptosis during atorvastatin treatment
2 secondary outcomes
Correlation of Tumor Apoptosis to Clinical Response
Time frame: 1 year
Atorvastatin Toxicity
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean Felsher principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Leukemia and Lymphoma, Non-Hodgkin, run by Dean Felsher 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 32 inclusion and 11 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 2 Dec 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?
Yes. Results are posted in the registry (first posted 2 Dec 2017). 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?
Tumor Apoptosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2017.