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HLA-mismatched unrelated donor (MMUD) and HLA-haploidentical donor (Haplo Donor) hematopoietic stem cell transplantation (HSCT) is associated with increased graft-versus-host-disease (GVHD) and impaired survival. The chemokine receptor 5 (CCR5) antagonist maraviroc has immunomodulatory properties potentially beneficial for GVHD control as it can blockade lymphocyte chemotaxis without impairing T-cell function. The aim of this study is to evaluate the safety and efficacy of maraviroc combined with standard graft-versus-host-disease prophylaxis in patients with hematologic malignancies after allogeneic stem cell transplantation from HLA-Unrelated or HLA-Mismatched Related donors. Based on the results of our previously small sample study with maraviroc combined with cyclosporine/tacrolimus and methotrexate for prophylaxis of GVHD, the investigators plan to perform the clinical trail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maraviroc + standard GVHD prophylaxis | Experimental | Maraviroc administration (in addition to the standard prophylaxis therapy of cyclosporine/tacrolimus and methotrexate) will start on day -2 and will end on day +30 after stem cell transplant, making the total number of days of drug administration 33 days. Maraviroc will be administered 300mg twice daily orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maraviroc | Drug | Maraviroc will be administered 300mg twice daily and start on day -2 end on day +30 after stem cell transplant for 33 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute GVHD Grades II-IV | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute GVHD Grades III-IV | By day +100 post-HSCT | |
| Incidence of Chronic GVHD | 1 Year | |
| Hematologic Recovery (Neutrophils and Platelets) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongmei Ning, M.D., Ph.D. | Contact | +86 10 66947405 | ninghongmei72@sina.com | |
| Yongfeng Su, M.D., Ph.D. | Contact | +86 10 66947122 | suyongfeng199705@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hu Chen, M.D., Ph.D. | Affiliated Hospital to Academy of Military Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematopoietic Stem Cell Transplantation | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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|
| Cyclosporine (in HLA-Unrelated Donor Transplantation) | Drug | Cyclosporine will be given intravenously at a dose of 2-3 mg/kg starting Day -1. Subsequent dosing will be based on blood levels. Patients were advanced to oral cyclosporine once they could tolerate. The dose should be adjusted accordingly to maintain a suggested target serum level of 150-250 ng/mL. In the absence of aGVHD, the oral cyclosporine dose was reduced by approximately 5% weekly, beginning on or near day 100, and therapy was usually discontinued by Day 180 after transplantation or relapse. |
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|
| Tacrolimus (in HLA-Mismatched Related Donor Transplantation) | Drug | Tacrolimus will be given orally at a dose of 0.05 mg/kg twince a day or intravenously at a dose of 0.03 mg/kg starting Day -3. Subsequent dosing should be adjusted accordingly to maintain a suggested target serum level of 5-10 ng/mL. Tacrolimus taper can be initiated at a minimum of 100 days post HSCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices but patients should be off tacrolimus by Day 180 post HSCT if there is no evidence of active GVHD. |
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| Methotrexate | Drug | Methotrexate will be administered intravenously at a dose of 15 mg/m^2 on day +1, and 10 mg/m^2 on day +3, +6 and +11 after HSC transplantation.at the doses of 15 mg/m^2 IV bolus on Day +1, and 10 mg/m^2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. The Day +11 dose of methotrexate will be not given to those patients who fail to reach white blood cell count (WBC) of more than 1.0Ă—10^9/L. |
|
|
| Up to day +100 post-HSCT |
| Disease Relapse or Progression | 1 Year |
| Incidence of Transplant-Related Mortality | By day +100 post-HSCT |
| Frequency of Grade 3 or Greater Toxicities | Up to day +100 post-HSCT |
| Incidence of Grade 2 and 3 Infections | 1 Year |
| Overall Survival | 1 Year |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D009190 | Myelodysplastic Syndromes |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
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| ID | Term |
|---|---|
| D000077592 | Maraviroc |
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| D016559 | Tacrolimus |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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