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The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.
The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.low dose of IL-2 (40 million U/m2) will be administered from WBC engraftment to day 90 post haploidentical transplantation. IL-2 will be administered three times a week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interleukin-2 interventions | Experimental | Patients with standard risk hematologic malignancies undergoing an unmodified haploidentical HCT will be eligible. Once patients achieved neutrophil engraftment will be given IL-2, 0.4×10E+6/M2/d, 3 times a week (separated by at least 1 day between injections) until day +90 (+/- 7 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interleukin-2 | Drug | Interleukin-2 (IL-2), 0.4×10E+6/M2/d, 3 times a week (separated by at least 1 day between injections) until day +90 (+/- 7 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| II-IV acute graft-versus-host disease (aGVHD) post transplantation | cumultive incidence of II-IV acute graft-versus-host disease (aGVHD) post transplantation | Day 100 post transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Severe chronic GVHD post transplantation | cumulative incidence of severe chronic GVHD post transplantation | 1 year post transplantation |
| CMV infection post transplantation | cumulative incidence of CMV infection post transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangyu Zhao | Contact | +861088324576 | zhao_xy@bjmu.edu.cn | |
| Xiaosu Zhao | Contact | +861088324576 | zhao.xiaosu@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojun Huang | Peking University Intitute of Hematology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Institute of Hematology | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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|
| Day 100 post transplantation |
| Measureable residual disease (MRD)-positive test post transplantation | cumulative incidence of MRD+ post transplantation | 1 year |
| Hematological relapse post transplantation | Cumulative incidence of hematological relapse post transplantation | 1 year |
| Disease-free free survival post transplantation | Cumulative incidence of DFS post transplantation | 1 year |
| Overall survival post transplantation | Cumulative incidence of OS post transplantation | 1 year |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |