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

NCT00948753 | Completed Phase 1 Results DMC

• 1 other identifier: UPCC 04708
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Keywords

Graft-versus-host disease; GVHD; Maraviroc; non-myeloablative allogeneic stem-cell transplantation; Hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (2)

• Safety of Maraviroc

  number of Adverse Events following exposure to Maraviroc

  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

  8 weeks

Secondary Outcomes (4)

• Pharmacokinetic Profile of Maraviroc in Patients Undergoing Nonmyeloablative Allogeneic SCT

  pre-dose, 1,2,3,4,6,12 hours post-dose

• Number of Patients Treated With Maraviroc During SCT That Develop Chronic GVHD

  1 year

• Rate of Early Mortality After Transplant

  1 year

• Number of Participants Who Relapsed During Study Period

  1 year and 11 months

Study Arms (3)

Phase 1: 150mg Maraviroc

EXPERIMENTAL

150mg twice daily

Drug: Maraviroc 150 MG

Phase 1: 300mg Maraviroc

EXPERIMENTAL

300mg twice daily

Drug: Maraviroc 300 mg

Phase 2: 300mg Maraviroc

EXPERIMENTAL

300mg twice daily

Drug: Maraviroc 300 mg Phase II

Interventions

Maraviroc 150 MG DRUG

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.

Also known as: CCR5 Blockade

Phase 1: 150mg Maraviroc

Maraviroc 300 mg DRUG

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.

Also known as: CCR5 Blockade

Phase 1: 300mg Maraviroc

Maraviroc 300 mg Phase II DRUG

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.

Also known as: CCR5 Blockade

Phase 2: 300mg Maraviroc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Related Publications (1)

• 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.

  PMID: 22784116 DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Maraviroc; Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: David Porter
• Organization: University of Pennsylvania Abramson Cancer Center

david.porter@pennmedicine.upenn.edu

215-662-2862

Study Officials

• David Porter, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2009
• First Posted: July 29, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 17, 2022
• Results First Posted: May 17, 2022

Record last verified: 2022-04