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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: 150mg Maraviroc | Experimental | 150mg twice daily |
|
| Phase 1: 300mg Maraviroc | Experimental | 300mg twice daily |
|
| Phase 2: 300mg Maraviroc | Experimental | 300mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pre-dose, 1,2,3,4,6,12 hours post-dose |
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Inclusion Criteria:
patients scheduled to undergo non-myeloablative allogeneic stem-cell transplantation.
meet institutional eligibility criteria for allogeneic SCT. Significant criteria are:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Porter, MD | University of Pennsylvania | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22784116 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: 150mg Maraviroc | 150mg twice daily Maraviroc 150 MG: 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. |
| FG001 | Phase 1: 300mg Maraviroc | 300mg twice daily Maraviroc 300 mg: 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. |
| FG002 | Phase 2: 300mg Maraviroc | 300mg twice daily Maraviroc 300 mg: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
| |||||||||||||
| Phase 2 |
|
Participants totaled 13 for phase I and 25 for phase 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: 150mg Maraviroc | 150mg twice daily Maraviroc 150 MG: 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. |
| BG001 | Phase 1: 300mg Maraviroc |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety of Maraviroc | number of Adverse Events following exposure to Maraviroc | patients receiving SCT | Posted | Number | Number of AEs | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: 150mg Maraviroc | 150mg twice daily Maraviroc 150 MG: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucositis | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Porter | University of Pennsylvania Abramson Cancer Center | 215-662-2862 | david.porter@pennmedicine.upenn.edu |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| D017322 | Clinical Trials, Phase II as Topic |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| 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. |
|
|
| 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. |
|
|
| 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 | 1 year |
| Rate of Early Mortality After Transplant | Number of participants who died without relapse within 1 year of SCT | 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. | 1 year and 11 months |
| NOT COMPLETED |
|
300mg twice daily Maraviroc 300 mg: 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. |
| BG002 | Phase 2: 300mg Maraviroc | 300mg twice daily Maraviroc 300 mg: 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Phase 2: 300mg Maraviroc | 300mg twice daily Maraviroc 300 mg: 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. |
|
|
| Primary | 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 | Posted | Number | Participants | 8 weeks |
|
|
|
| Secondary | 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. | not enough data was collected to reach statistical power for plasma maraviroc levels in the Phase 2 group. | Posted | Number | number of patients to reach target | pre-dose, 1,2,3,4,6,12 hours post-dose |
|
|
|
| Secondary | 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 | Participants | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Rate of Early Mortality After Transplant | Number of participants who died without relapse within 1 year of SCT | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 1 year and 11 months |
|
|
|
| 0 |
| 7 |
| 7 |
| 7 |
| EG001 | Phase 1: 300mg Maraviroc | 300mg twice daily Maraviroc 300 mg: 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. | 0 | 6 | 6 | 6 |
| EG002 | Phase 2: 300mg Maraviroc | 300mg twice daily Maraviroc 300 mg: 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. | 0 | 25 | 17 | 25 |
| Bacteremia | Blood and lymphatic system disorders |
|
| Abnormal LFTs | Gastrointestinal disorders |
|
| Urinary Tract Infection | Infections and infestations |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders |
|
| Gout | Blood and lymphatic system disorders |
|
| Hyperglycemia | Blood and lymphatic system disorders |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Hypotension | Cardiac disorders |
|
| Septic arthritis | Infections and infestations |
|
| Hyponatremia | Blood and lymphatic system disorders |
|
| Psychosis | Psychiatric disorders |
|
| Headache | Nervous system disorders |
|
| Acute kidney injury | Gastrointestinal disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002986 | Clinical Trials as Topic |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |