Hematopoietic Stem Cell Microtransplantation for in AML

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02676856

Collaborator

Guangzhou First People's Hospital (Other), Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other), Peking University People's Hospital (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other), Zhujiang Hospital (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Procedure: hematopoietic stem cell microtransplantation-long-term Procedure: hematopoietic stem cell microtransplantation-short-term Drug: Conditioning for CR group Drug: Conditioning for Non-CR group	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia

Actual Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CR group 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.	Procedure: hematopoietic stem cell microtransplantation-long-term Stem cell infusion are administrated once three months for 3 times with the cell count of 310^8/kg/once. Drug: Conditioning for CR group* For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).
Experimental: Non-CR group 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.	Procedure: hematopoietic stem cell microtransplantation-short-term Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 310^8/kg/once. Drug: Conditioning for Non-CR group* For the patients in Non-CR group, the conditioning regimens include: IAC（IDA 12mg/m2 d1-3，Ara-C 200 mg/m2 d1-7， Cladribine 5mg/m2 d1-5) or HD Ara-C(high-dose Ara-c 3g/m2 q12h d1-3).

Arm

Intervention/Treatment

Experimental: CR group

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.

Procedure: hematopoietic stem cell microtransplantation-long-term

Stem cell infusion are administrated once three months for 3 times with the cell count of 3*10^8/kg/once.

Drug: Conditioning for CR group

For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).

Experimental: Non-CR group

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.

Procedure: hematopoietic stem cell microtransplantation-short-term

Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 3*10^8/kg/once.

Drug: Conditioning for Non-CR group

For the patients in Non-CR group, the conditioning regimens include: IAC（IDA 12mg/m2 d1-3，Ara-C 200 mg/m2 d1-7， Cladribine 5mg/m2 d1-5) or HD Ara-C(high-dose Ara-c 3g/m2 q12h d1-3).

Outcome Measures

Primary Outcome Measures

CR rate [2 years]
The primary endpoint is CR (complete remission) rate in 2 years after microtransplantation
relapse rate [2 years]

Secondary Outcome Measures

Overall Survival [2 years]
Disease-free Survival [2 years]
Incidence of chimerism [2 years]
Incidence of chimerism will be evaluated in the patients. Both peripheral-blood cells and bone marrow are tested for hematopoietic donor chimerism by a standard cytogenetic analysis and a semiquantitative PCR-based analysis of the short tandem repeats.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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)