Malignant NeoplasmPhase 2NCT01525407

Donor Atorvastatin Treatment for Preventing Severe Acute Graft-Versus-Host Disease in Patients Undergoing Myeloablative Peripheral Blood Stem Cell Transplantation

A Phase 2 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Atorvastatin Calcium and Peripheral Blood Stem Cell Transplantation in people with Malignant Neoplasm, run by Fred Hutchinson Cancer Center at 3 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Malignant Neoplasm
What is being tested?: Allogeneic Hematopoietic Stem Cell Transplantation, Atorvastatin Calcium and Peripheral Blood Stem Cell Transplantation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 3 sitesUnited States
Study dates: May 2012to Feb 2016
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

Human leukocyte antigen (HLA)-identical sibling donor
Myeloablative preparative regimen (i.e., >= TBI 12.0 Gy, >= busulfan (BU) 8.0 mg/kg PO, >= BU 6.4 mg/kg intravenously (IV), >= treosulfan 42 g/m^2 IV) according to investigational study or standard treatment plan; other "myeloablative" preparative regimens are acceptable as long as they are approved by the principal investigator or designee
Transplantation of PBSC
Cyclosporine (CSP)-based postgrafting immunosuppression
Willingness to give informed consent
DONOR: Age >= 18 years
DONOR: HLA genotypically identical sibling
DONOR: Willingness to give informed consent

Who cannot join

Nonmyeloablative preparative regimen
Participation in an investigational study that has acute GVHD as the primary endpoint
The allogeneic PBSC donor has a contraindication to statin treatment
DONOR: Age < 18 years
DONOR: Active liver disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels > 2 times the upper limit of normal [ULN])
DONOR: History of myopathy

Show all 14Show fewer

DONOR: Hypersensitivity to atorvastatin
DONOR: Pregnancy
DONOR: Nursing mother
DONOR: Current serious systemic illness
DONOR: Concurrent treatment with strong inhibitors of hepatic cytochrome P450 (CYP) 3A4 (i.e. clarithromycin, erythromycin, protease inhibitors, azole antifungals)
DONOR: Current use of statin drug
DONOR: Failure to meet Fred Hutchinson Cancer Research Center (FHCRC) or local criteria for stem cell donation
DONOR: Total creatinine kinase > 2 times the ULN

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Colorado Blood Cancer Institute
Denver, Colorado, 80907
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
Stanford University Hospitals and Clinics
Stanford, California, 94305

Other trials in United States

About this study

Official title: Donor Statin Treatment for Prevention of Severe Acute GVHD After Myeloablative Hematopoietic Cell Transplantation

This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the patient's immune system reject the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving atorvastatin to the donor before transplant may prevent this from happening.

Read the detailed description

PRIMARY OBJECTIVES:

To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD.

SECONDARY OBJECTIVES:

To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable and safe.

OUTLINE:

Donors receive atorvastatin orally (PO) beginning on day -14 and continuing until the last day of stem cell collection.

Conditions: Malignant Neoplasm
Being tested: Allogeneic Hematopoietic Stem Cell Transplantation, Atorvastatin Calcium, Peripheral Blood Stem Cell Transplantation
Medical subject headings: Neoplasms

What participants receive

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

Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery
Also called allogeneic stem cell transplantation, HSC, HSCT
Undergo myeloablative allogeneic PBSC transplant
Atorvastatin CalciumDrug
Also called CI-981, Lipitor
Given PO
Peripheral Blood Stem Cell TransplantationProcedure or surgery
Also called PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplantation
Undergo myeloablative allogeneic PBSC transplant

Study groups in NCT01525407
Study group	Role	What they receive
Supportive care (donor statin treatment)	Experimental	Donors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection. Receives: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Drug: Atorvastatin Calcium; Procedure: Peripheral Blood Stem Cell Transplantation

What is being measured

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

Grade 3-4 Acute GVHD
Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.
Measured: First 100 days after transplant

Secondary outcomes (9)

Chronic Extensive GVHD
Cumulative incidence rate of chronic extensive GVHD with death as a competing risk, assessed at 2 years in the patients/recipients.
Measured: 2 years post transplant
Disease-free Survival
Evaluated as Kaplan-Meier estimate in the patients/recipients.
Measured: 1 year after transplant
Grades II-IV Acute GVHD
Cumulative incidence rate of grades II-IV acute GVHD with death as a competing risk, assessed at 100 days in the patients/recipients.
Measured: First 100 days after transplant
Non-relapse Mortality
Cumulative incidence rate of non-relapse mortalities, assessed at day 100 in the patients/recipients.
Measured: At day 100
Non-relapse Mortality
Cumulative incidence rate of non-relapse mortalities, assessed at one year in the patients/recipients.
Measured: At 1 year after HCT
Overall Survival
Determined and presented as Kaplan-Meier estimates, assessed at 1 year in the patients/recipients.
Measured: 1 year after transplant
Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity
Measured: Until completion of stem cell collection (on average 14 days)
Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy
Measured: First 100 days after transplant
Recurrent or Progressive Malignancy
Cumulative incidence rate of recurrent or progressive malignancy with death as a competing risk, assessed at 3 years in the patients/recipients.
Measured: Up to 3 years

Timeline

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

May 2012Feb 2016

First posted3 Feb 2012 (estimated)
Study startMay 2012
Primary completionSep 2015
Study completionFeb 2016

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 Malignant NeoplasmStudies of the same condition, open and under way.
More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
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: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01525407
Sponsor's protocol ID: 2545.00
Other IDs: NCI-2011-03827, 2545.00, P30CA015704, R01HL108307
Status last verified: Jul 2017
First submitted: 31 Jan 2012
Last updated: 17 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
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
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm

All Malignant Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Donor Statin Treatment for Prevention of Severe Acute GVHD After Myeloablative Hematopoietic Cell Transplantation
ClinicalTrials.gov ID: NCT01525407
Acronym / sponsor ID: 2545.00
Conditions: Malignant Neoplasm
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Fred Hutchinson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
Study start: May 2012
Primary completion: Sep 2015 (actual)
Study completion: Feb 2016 (actual)
First posted: 3 Feb 2012 (estimated)
Results: Posted 17 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To assess whether 2 weeks of donor statin treatment reduces the risk of severe acute GVHD.

SECONDARY OBJECTIVES:

To assess whether 2 weeks of statin treatment of normal PBSC donors is feasible, tolerable and safe.

OUTLINE:

Donors receive atorvastatin orally (PO) beginning on day -14 and continuing until the last day of stem cell collection.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Supportive care (donor statin treatment)	Experimental	Procedure: Allogeneic Hematopoietic Stem Cell Transplantation, Drug: Atorvastatin Calcium, Procedure: Peripheral Blood Stem Cell TransplantationDonors receive atorvastatin calcium PO beginning on day -14 and continuing until the last day of stem cell collection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Human leukocyte antigen (HLA)-identical sibling donor
Myeloablative preparative regimen (i.e., >= TBI 12.0 Gy, >= busulfan (BU) 8.0 mg/kg PO, >= BU 6.4 mg/kg intravenously (IV), >= treosulfan 42 g/m^2 IV) according to investigational study or standard treatment plan; other "myeloablative" preparative regimens are acceptable as long as they are approved by the principal investigator or designee
Transplantation of PBSC
Cyclosporine (CSP)-based postgrafting immunosuppression
Willingness to give informed consent

Key exclusion criteria (14 listed)

Nonmyeloablative preparative regimen
Participation in an investigational study that has acute GVHD as the primary endpoint
The allogeneic PBSC donor has a contraindication to statin treatment
DONOR: Age < 18 years
DONOR: Active liver disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels > 2 times the upper limit of normal [ULN])

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
Allogeneic Hematopoietic Stem Cell TransplantationAlso: allogeneic stem cell transplantation, HSC, HSCTUndergo myeloablative allogeneic PBSC transplant	Procedure or surgery	Supportive care (donor statin treatment)
Atorvastatin CalciumAlso: CI-981, LipitorGiven PO	Drug	Supportive care (donor statin treatment)
Peripheral Blood Stem Cell TransplantationAlso: PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell TransplantationUndergo myeloablative allogeneic PBSC transplant	Procedure or surgery	Supportive care (donor statin treatment)

Primary outcome

Grade 3-4 Acute GVHD
Time frame: First 100 days after transplant
Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.

9 secondary outcomes

Chronic Extensive GVHD
Time frame: 2 years post transplant
Disease-free Survival
Time frame: 1 year after transplant
Grades II-IV Acute GVHD
Time frame: First 100 days after transplant
Non-relapse Mortality
Time frame: At day 100
Non-relapse Mortality
Time frame: At 1 year after HCT
Overall Survival
Time frame: 1 year after transplant
Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity
Time frame: Until completion of stem cell collection (on average 14 days)
Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy
Time frame: First 100 days after transplant
Recurrent or Progressive Malignancy
Time frame: Up to 3 years

Results and safety

Results posted to the registry on 17 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Donors	41	38
Patients	42	38

Primary outcome: Grade 3-4 Acute GVHD

Time frame: First 100 days after transplant. Number (95% Confidence Interval). Unit: probability

Measure	Patients n = 38
Value	0.21 (0.10 to 0.35)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Donor: SAEs, AEs (≥ grade 2) and UPs will be monitored and recorded from the time the donor starts atorvastatin therapy through the time of discharge from the transplant center after donation of stem cells or 7 days after the discontinuation of the medication, whichever occurs earlier. Recipient: SAEs and UPs (life-threatening or fatal) will be monitored and recorded from the time the recipient starts conditioning therapy through day 100 or discharge from the center, whichever occurs earlier.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patient Adverse Events	21 of 38 (55.3%)	0 of 38 (0%)	Not reported
Donor Adverse Events	0 of 41 (0%)	0 of 41 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Malignant Neoplasm

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
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
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine 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.

Marco Mielcarek principal investigator

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 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 17 Aug 2017. 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 17 Aug 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?

Grade 3-4 Acute GVHD (time frame: First 100 days after transplant). 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 NCT01525407.

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 17 Aug 2017.