Graft-versus-host DiseasePhase 1/2NCT00948753

Maraviroc in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation

A Phase 1/2 study testing Maraviroc 150 MG, Maraviroc 300 mg and Maraviroc 300 mg Phase II in people with Graft-versus-host Disease and Hematopoietic Stem Cell Transplantation, run by Abramson Cancer Center at Penn Medicine.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Graft-versus-host Disease, Hematopoietic Stem Cell Transplantation
What is being tested?: Maraviroc 150 MG, Maraviroc 300 mg and Maraviroc 300 mg Phase II
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: No sites listed yet
Study dates: Jun 2009to Apr 2011
Phase: Phase 1/2
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

patients scheduled to undergo non-myeloablative allogeneic stem-cell transplantation.
meet institutional eligibility criteria for allogeneic SCT. Significant criteria are:
Renal function: Serum creatinine <2; or calculated creatinine clearance > 40 mL/min/1.72m2;
Hepatic function: Baseline direct bilirubin, ALT or AST lower than three times the upper limit of normal;
Pulmonary disease: FVC or FEV1 > 40% predicted; Cardiac ejection fraction > 40%.

Who cannot join

Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
Patients who are not undergoing standard non-myeloablative SCT with Flu/Bu conditioning and Tax/MTX GVHD prophylaxis
Patients with uncontrolled bacterial, viral or fungal infections
Patients who take strong inducers or inhibitors of the CYP450A4
Patients receiving other investigational drugs for GVHD
Women who are pregnant, plan to become pregnant or are breastfeeding

About this study

Official title: Safety and Efficacy of Maraviroc, a CCR5-inhibitor in Prophylaxis of Graft-Versus-Host Disease in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation

This study investigates the effectiveness and safety of Maraviroc (an oral medication given twice daily given in addition to the standard GVHD prophylaxis) in preventing Graft versus Host Disease (GVHD) in patients undergoing non-myeloablative allogeneic stem-cell transplantation (SCT). Subjects will receive Maraviroc bid (in addition to standard GVHD prophylaxis) beginning after the last dose of the chemotherapy conditioning regimen until day 30 after stem-cell infusion.

Conditions: Graft-versus-host Disease, Hematopoietic Stem Cell Transplantation
Being tested: Maraviroc 150 MG, Maraviroc 300 mg, Maraviroc 300 mg Phase II
Keywords: Graft-versus-host disease, GVHD, Maraviroc, non-myeloablative allogeneic stem-cell transplantation, Hematopoietic stem cell transplantation
Medical subject headings: Graft vs Host Disease

What participants receive

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

Maraviroc 150 MGDrug
Also called CCR5 Blockade
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
Maraviroc 300 mgDrug
Also called CCR5 Blockade
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
Maraviroc 300 mg Phase IIDrug
Also called CCR5 Blockade
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.

Study groups in NCT00948753
Study group	Role	What they receive
Phase 1: 150mg Maraviroc	Experimental	150mg twice daily Receives: Drug: Maraviroc 150 MG
Phase 1: 300mg Maraviroc	Experimental	300mg twice daily Receives: Drug: Maraviroc 300 mg
Phase 2: 300mg Maraviroc	Experimental	300mg twice daily Receives: Drug: Maraviroc 300 mg Phase II

What is being measured

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

Safety of Maraviroc
number of Adverse Events following exposure to Maraviroc
Measured: 1 year
Efficacy of Maraviroc
Efficacy is measured by number of participants progressing to acute GVHD. If acute GVHD is noted in a participant following exposure to study drug, then efficacy was not achieved.
If no GVHD was noted following exposure, then efficacy was achieved in that participant
Measured: 8 weeks

Secondary outcomes (4)

Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT
Plasma maraviroc levels were measured in the blood with a target level of 100 ng per milliliter. Blood was drawn on Day 0 and Day 10-12 at pre-dose, 1, 2, 3, 4, 6, and 12 hours post-dose. Data was analyzed looking at the number of patients to achieve the target of 100 ng per milliliter at any time point.
Measured: pre-dose, 1,2,3,4,6,12 hours post-dose
Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD
count of how many patients treated with Maraviroc during SCT go on to develop chronic GVHD in 1 year
Measured: 1 year
Rate of Early Mortality After Transplant
Number of participants who died without relapse within 1 year of SCT
Measured: 1 year
Number of Participants Who Relapsed During Study Period
Number of participants who received Maraviroc during SCT who relapsed within 1 year and 11 months. This was based on a diagnosis made by their physician that their primary cancer had returned.
Measured: 1 year and 11 months

Timeline

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

Jun 2009Apr 2011

First posted29 Jul 2009 (estimated)
Study startJun 2009
Primary completionApr 2011
Study completionApr 2011

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Graft-versus-host DiseaseStudies of the same condition, open and under way.
More trials run by Abramson Cancer Center at Penn MedicineThe 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00948753
Sponsor's protocol ID: UPCC 04708
Status last verified: Apr 2022
First submitted: 23 Jul 2009
Last updated: 17 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Reshef R, Luger SM, Hexner EO, Loren AW, Frey NV, Nasta SD, Goldstein SC, Stadtmauer EA, Smith J, Bailey S, Mick R, Heitjan DF, Emerson SG, Hoxie JA, Vonderheide RH, Porter DL. Blockade of lymphocyte chemotaxis in visceral graft-versus-host disease. N Engl J Med. 2012 Jul 12;367(2):135-45. doi: 10.1056/NEJMoa1201248.
PubMed 22784116

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?

Official record

Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
RecruitingPhase 1/2
The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease

All Graft-versus-host Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Maraviroc, a CCR5-inhibitor in Prophylaxis of Graft-Versus-Host Disease in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation
ClinicalTrials.gov ID: NCT00948753
Acronym / sponsor ID: UPCC 04708
Conditions: Graft-versus-host Disease, Hematopoietic Stem Cell Transplantation
Keywords: Graft-versus-host disease, GVHD, Maraviroc, non-myeloablative allogeneic stem-cell transplantation, Hematopoietic stem cell transplantation
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Abramson Cancer Center at Penn MedicineUniversity, hospital or other
Study start: Jun 2009 (actual)
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 29 Jul 2009 (estimated)
Results: Posted 17 May 2022

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Phase 1: 150mg Maraviroc	Experimental	Drug: Maraviroc 150 MG150mg twice daily
Phase 1: 300mg Maraviroc	Experimental	Drug: Maraviroc 300 mg300mg twice daily
Phase 2: 300mg Maraviroc	Experimental	Drug: Maraviroc 300 mg Phase II300mg twice daily

Who may qualify

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

Key inclusion criteria (5 listed)

patients scheduled to undergo non-myeloablative allogeneic stem-cell transplantation.
meet institutional eligibility criteria for allogeneic SCT. Significant criteria are:

Key exclusion criteria (6 listed)

Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
Patients who are not undergoing standard non-myeloablative SCT with Flu/Bu conditioning and Tax/MTX GVHD prophylaxis
Patients with uncontrolled bacterial, viral or fungal infections
Patients who take strong inducers or inhibitors of the CYP450A4
Patients receiving other investigational drugs for GVHD

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
Maraviroc 150 MGAlso: CCR5 BlockadeMaraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.	Drug	Phase 1: 150mg Maraviroc
Maraviroc 300 mgAlso: CCR5 BlockadeMaraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.	Drug	Phase 1: 300mg Maraviroc
Maraviroc 300 mg Phase IIAlso: CCR5 BlockadeMaraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.	Drug	Phase 2: 300mg Maraviroc

Primary outcome

Safety of Maraviroc
Time frame: 1 year
number of Adverse Events following exposure to Maraviroc
Efficacy of Maraviroc
Time frame: 8 weeks
Efficacy is measured by number of participants progressing to acute GVHD. If acute GVHD is noted in a participant following exposure to study drug, then efficacy was not achieved. If no GVHD was noted following exposure, then efficacy was achieved in that participant

4 secondary outcomes

Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT
Time frame: pre-dose, 1,2,3,4,6,12 hours post-dose
Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD
Time frame: 1 year
Rate of Early Mortality After Transplant
Time frame: 1 year
Number of Participants Who Relapsed During Study Period
Time frame: 1 year and 11 months

Results and safety

Results posted to the registry on 17 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: 150mg Maraviroc	7	7
Phase 1: 300mg Maraviroc	6	6
Phase 2: 300mg Maraviroc	0	0

Primary outcome: Safety of Maraviroc

Time frame: 1 year. Number. Unit: Number of AEs

Measure	Phase 1: 150mg Maraviroc n = 7	Phase 1: 300mg Maraviroc n = 6	Phase 2: 300mg Maraviroc n = 25
Value	8	6	18

Population analysed: patients receiving SCT

Primary outcome: Efficacy of Maraviroc

Time frame: 8 weeks. Number. Unit: Participants

Measure	Phase 1: 150mg Maraviroc n = 7	Phase 1: 300mg Maraviroc n = 6	Phase 2: 300mg Maraviroc n = 25
Value	0	0	0

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: 150mg Maraviroc	0 of 7 (0%)	7 of 7 (100%)	Not reported
Phase 1: 300mg Maraviroc	0 of 6 (0%)	6 of 6 (100%)	Not reported
Phase 2: 300mg Maraviroc	0 of 25 (0%)	17 of 25 (68%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22784116Reshef R, Luger SM, Hexner EO, Loren AW, Frey NV, Nasta SD, Goldstein SC, Stadtmauer EA, Smith J, Bailey S, Mick R, Heitjan DF, Emerson SG, Hoxie JA, Vonderheide RH, Porter DL. Blockade of lymphocyte chemotaxis in visceral graft-versus-host disease. N Engl J Med. 2012 Jul 12;367(2):135-45. doi: 10.1056/NEJMoa1201248.

Related trials for Graft-versus-host Disease

Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
RecruitingPhase 1/2
The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease

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.

David Porter, MD principal investigator

University of Pennsylvania

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 5 inclusion and 6 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 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 May 2022). 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?

Safety of Maraviroc (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT00948753, 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 17 May 2022.