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An open, multi-center, randomized trial comparing haploidentical HSCTs from young non-first-degree and older first-degree donors in hematological malignancies
This is an open, multi-center, randomized trial comparing the clinical outcomes of haploidentical HSCTs from young non-first-degree and older first-degree donors in hematological malignancies. This study is indicated for patients with hematological malignancies including acute leukemias and MDS who are eligible to haploidentical HSCTs. 2 groups of patients will be enrolled with 116 in each group. The clinical criteria including survival, relapse, transplantation-related mortality will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-first-degree donor | Active Comparator | Each patient receive graft from a non-first degree donor aged ≤40 Conditoning regimens are decided by each center accoding to disease risk, patient age & status, and cormobidity index.The centers are required to use the same principle when treating NFD and FD patients. The used protocol in the current study included: For MAC: use BU-CY-based (described in detail) For RIC: use BUFlu: Drug: Fludarabine 30 mg/m²/kg, administered IV d-10 through d-5. Drug: Busulfan, 3.2 mg/kg/day administered IV day -6 (BU2) or -7 through -5 (BU3). Other conditioning regimen may include: TBF, FluMel, FBM, Cy-TBI, Flu-TBI. |
|
| First-degree donor | Active Comparator | Each patients receive graft from a first-degree donor aged >50 Conditoning regimens are decided by each center accoding to disease risk, patient age & status, and cormobidity index.The centers are required to use the same principle when treating NFD and FD patients. The used protocol in the current study included: For MAC: use BU-CY-based (described in detail) For RIC: use BUFlu: Drug: Fludarabine 30 mg/m²/kg, administered IV d-10 through d-5. Drug: Busulfan, 3.2 mg/kg/day administered IV day -6 (BU2) or -7 through -5 (BU3). Other conditioning regimen may include: TBF, FluMel, FBM, Cy-TBI, Flu-TBI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytarabine | Drug | 4 mg/m2/day administered IV day -10 through -9. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. | 2 years |
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Patient Inclusion Criteria:
Eligible diagnoses:
AML（excluding APL） with at least one of the following:
Mixed-phenotype acute leukemia (MPAL) in morphological remission Acute lymphoblastic leukemia (T or B) in morphological remission
MDS with at least one of the following:
IPSS score of INT-2 or greater
IPSS score of INT-1 with life-threatening cytopenias, including those generally requiring greater than weekly transfusions
Patient Exclusion Criteria
Donor Inclusion Criteria:
Donor Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Luo, MD | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Changsha | China | ||||
| Xinqiao Hospital, State Key Laboratory of Trauma and Chemical Poisoning, Army Medical University |
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| Busulfan | Drug | 3.2 mg/kg/day administered IV day -8 through -6. |
|
| Cyclophosphamide | Drug | 1.8 g/m2/day administered IV day -5 through -4. |
|
| Me-CCNU | Drug | 250mg/m2 once administered orally on day -3. |
|
| Rabbit antithymocyte globulin | Drug | Between 6mg/kg total dose administered IV day -5 through -2 AND 7.5mg/kg total dose administered IV day -5 through -2. |
|
| Allogeneic HSCT | Procedure | Day 0 |
|
| Cyclosporin A | Drug | 2.5 mg/kg/day administered intravenously from day -7, target: 200-300ng/mL. Usually tapered during the second month, and ended in complete withdrawal during the ninth month after transplantation. |
|
| Mycophenolate Mofetil | Drug | 500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100. |
|
| MTX | Drug | 15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9. |
|
| Cumulative incidence of transplant-related nonrelapse mortality (NRM) |
All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. |
| 2 years |
| Cumulative incidence of disease relapse or progression | All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. | 2 years |
| GVHD-free, relapse-free survival (GRFS) | All patients will be tracked from Day 0 to date of first objective disease progression, death from any cause, or last patient evaluation. Patients who have not progressed or died will be censored at the last date they were assessed and deemed free of relapse or progression. GRFS is defined as survival with no evidence of relapse/progression, grade III to IV aGVHD, and systemic therapy-requiring cGVHD. | 2 years |
| Cumulative incidence of total acute and grade II-IV acute GVHD | Date of symptom onset, maximum clinical grade, and dates and types of treatment will be recorded. Dates of symptom onset of grade II or higher acute GVHD and grade III-IV acute GVHD will be recorded. | 180 days |
| Cumulative incidence of total and and moderate-severe chronic GVHD | Date of symptom onset, maximum clinical grade, and dates and types of treatment will be recorded. Dates of symptom onset of chronic GVHD and severe chronic GVHD will be recorded. | 2 years |
| Chongqing |
| China |
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | China |
| Zhejiang Provincial People's Hospital | Hangzhou | China |
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | China |
| The Affiliated People's Hospital of Ningbo University | Ningbo | China |
| The First Affiliated Hospital of Ningbo University | Ningbo | China |
| The First Affiliated Hospital of Soochow University | Suzhou | China |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D012673 | Semustine |
| C512542 | thymoglobulin |
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D008130 | Lomustine |
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009603 | Nitroso Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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