Hematologic Malignancy, Stem Cell Transplant Complications
Conditions
Keywords
allogenetic hematopoietic stem cell transplant, HLA locus, Hematologic Malignancy
Brief summary
The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.
Detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative procedure for patients with hematological malignancies.Donor-recipient human leukocyte antigen (HLA) compatibility plays a key role in successful allo-HSCT as HLA-matching has a direct impact on the risk of GvHD, non-relapse mortality (NRM), and survival. Suitable, matched or haploidentical donors are not always available or accessible, even in the era of the international registries.Therefore, there is a need for new strategies that could negate the barrier of HLA-mismatching, allowing allo-HSCT from traditionally prohibitive highly mismatched donors.The aim of the study is to evaluate the efficacy and safety of Beijing protocol in malignant haematologic disease patients receiving more than 5/10 HLA-mismatched allo-HSCT.
Interventions
COMBINATION_PRODUCTBeijing protocol
For patients \<55 years and HCT-CI≤ 3：Ara-C(4g/m2/day,-9 days),Bu(9.6mg/kg,-8 days to -6 days),Cy(1,800mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(7.5-10 mg/kg,-5 to -2 days) For patients ≥ 55 years or HCI-CI\>3：Ara-C(2g/m2/day,-10 days to -9 days),Bu(9.6mg/kg,-8 days to -6 days),Flu(30mg/m2/day,-6 days to -2 days),Cy(1,000mg/m2/day,-5 days to -4 days),semustine(250mg/m2,-3 days),ATG(7.5-10 mg/kg,-5 to -2 days).
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No
Inclusion criteria
* hematologic malignancy patients * patients eligible for the transplantation of allogeneic hematopoietic stem cells; * patients unavailable with HLA matched donor or related haploidentical donor * voluntary participation in this study and signing the informed consent form.
Exclusion criteria
* Patients with the severe infections; * Pregnant or lactating women * Patients who are not eligible for hematopoietic stem cell transplantation; * Patients who are enrolled in other clinical trials within 1 month; * Patients who may not be able to complete the study for other reasons, or may be considered by the investigator not suitable to participate in the study; * Patients unable to properly understand or refusing to accept the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year LFS | Participants will be followed for an expected average of 1 years | defined as disease relapse, disease progression or death (whichever occurs first) within 1 year from the day the patient receives transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year OS | Participants will be followed for an expected average of 1 years | defined as survival rate within 1 year from the day the patient receives transplantation, calculated based on death from any cause. |
| 1-year TRM | Participants will be followed for an expected average of 1 years | defined as death from any cause other than disease relapse within 1 year from the day the patient receives transplantation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | Participants will be followed for an expected average of 1 years | The incidence rate of acute GVHD, chronic GVHD, CMV activation, EBV activation after transplantation |
| Engraftment rate | Participants will be followed for an expected average of 1 years | The success rate of engraftment after transplantation |
Countries
China
Contacts
Primary ContactYu Wang, Prof.
Outcome results
None listed