Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: Acute Leukemia; Chronic Myeloid Leukemia; Myelodysplastic Syndrome

Treatments: Drug: Methotrexate; Drug: Cyclosporin A; Procedure: HSCT from MUD; Procedure: HSCT from HRD; Drug: Mycophenolate mofetil; Drug: Antithymocyte globulin; Procedure: HSCT from MSD

Study type: Interventional

Funder types: Other

Identifiers

NCT02487069

Alternative Donor HSCT-2015

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of allogeneic hematopoietic stem cell transplantation (allo-HSCT) from matched sibling donor (MSD),matched unrelated donor (MUD) and haploidentical related donors(HRD) in the treatment of hematologic malignancy.

Full description

Currently, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy for a majority of malignant hematologic diseases, especially acute leukemia. HSCT from MSD offers the best results for these diseases, but lack of this donor resource has restricted its wide application. HSCT from MUD provides another option, but MUDs still cannot satisfy all patients due to unsuccessful donor searches. Almost all patients have an available related donor with whom they share a single HLA haplotype (ie, haploidentical related donor), and it owns the advantage of immediate availability, especially for those who urgently need transplantation.The results of transplantation from HRD have improved significantly over the past few years. However, the results from such haploidentical transplantation have not formally been compared with those of transplantation in patients contemporaneously using MSDs and MUDs for hematologic malignancy.

Enrollment: 876 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary disease is acute leukemia/MDS/CML
• Receiving allo-HSCT

Exclusion criteria

• cardiac dysfunction (particularly congestive heart failure)
• hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase> 2 times the upper limit of normal)
• renal dysfunction (creatinine clearance rate < 30 mL/min)
• Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
• Patients with any conditions not suitable for the trial (investigators' decision)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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876 participants in 3 patient groups

MSD group

Experimental group

Description:

The patients will received HSCT from MSD.

Treatment:

Procedure: HSCT from MSD

Drug: Mycophenolate mofetil

Drug: Methotrexate

Drug: Cyclosporin A

MUD group

Experimental group

Description:

The patients will received HSCT from MUD.

Treatment:

Procedure: HSCT from MUD

Drug: Antithymocyte globulin

Drug: Methotrexate

Drug: Cyclosporin A

HRD group

Experimental group

Description:

The patients will received HSCT from HRD.

Treatment:

Procedure: HSCT from HRD

Drug: Mycophenolate mofetil

Drug: Antithymocyte globulin

Drug: Methotrexate

Drug: Cyclosporin A