Hematopoietic Stem Cell Microtransplantation for in AML

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Conditioning for CR group; Procedure: hematopoietic stem cell microtransplantation-short-term; Drug: Conditioning for Non-CR group; Procedure: hematopoietic stem cell microtransplantation-long-term

Study type: Interventional

Funder types: Other

Identifiers

NCT02676856

Microtransplantation-AML-2016

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of hematopoietic stem cell microtransplantation for in acute myeloid leukemia (AML)patients who can not receive hematopoietic stem cell transplantation (HSCT).

Full description

Despite allogeneic HSCT is the only curative therapy for AML, some patients can not receive transplantation due to intolerance of transplant-related toxicity or unwillingness of HSCT. For these patients, microtransplantation seems an optional therapy. However, the efficacy still remain unclear.

Enrollment: 40 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AML patients who have received induction chemotherapy with moderate-high dose Ara-C and 3 courses consolidate chemotherapy
• Intolerance or unwillingness of allogeneic HSCT
• Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion criteria

• 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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40 participants in 2 patient groups

CR group

Experimental group

Description:

For the patients in CR group(CR status of AML at microtransplantation), the conditioning regimen is high-dose (HD) Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with long-term course.

Treatment:

Drug: Conditioning for CR group

Procedure: hematopoietic stem cell microtransplantation-long-term

Non-CR group

Experimental group

Description:

For the patients in Non-CR group (PR or NR status of AML at microtransplantation), the conditioning regimens include: IAC or HD Ara-C. Hematopoietic stem cell microtransplantation will be given to these patients with short-term course.

Treatment:

Drug: Conditioning for Non-CR group

Procedure: hematopoietic stem cell microtransplantation-short-term