ASCT for Relapsed APL After Molecular Remission

Shanghai Jiao Tong University School of Medicine

Status and phase: Terminated; Phase 2

Conditions: Acute Promyelocytic Leukemia; Relapse

Treatments: Procedure: autologous hematopoietic cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00907582

MHOPES-APL09

Details and patient eligibility

About

For relapsed acute promyelocytic leukemia after all-trans retinoic acid (ATRA) and arsenic treatment, remission can be achieved by chemotherapy with ATRA and/or arsenic and addition of mylotarg. Autologous hematopoietic cell transplantation using a polymerase chain reaction (PCR) negative graft is important treatment option to obtain sustainable remission. This study is to test the efficacy and the safety of conditioning regimen with idarubicin and busulfan for relapsed Acute Promyelocytic Leukemia (APL).

Full description

Once relapsed acute promyelocytic leukemia achieved molecular remission after all-trans retinoic acid (ATRA) and arsenic treatment, PBSC was mobilized and collected with further confirmation of molecular remission via RT-PCR.

Patients received autologous hematopoietic cell transplantation.

Enrollment: 5 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women between age 18-60 years old
• Acute promyelocytic leukemia after relapse with confirmed cytogenetics t(15;17) and molecular analysis (PML-RARalpha)
• Mobilized peripheral CD34+ over 2x106/kg with negative PML-RAR alpha confirmed by PCR
• European Cooperative Oncology Group performance status 0-3
• Serum bilirubin < 1.5x the upper limit of normal (ULN)
• Serum alanine transaminase (ALT)/aspartate transaminase values < 2.5 x ULN
• Subjects (or their legally acceptable representatives) must signed an informed consent document indicating that they understanding the purpose of and procedures required for the study and are willing to participate in the study

Exclusion criteria

• Woman of child bearing potential
• Serum creatinine > 400 Micromol/l after initial resuscitation patients with previous Grade 2-4 peripheral neuropathy
• Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug)
• Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or III-IV heart failure
• Known allergy to idarubicin

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

ASCT in relapsed APL

Experimental group

Description:

autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission

Treatment:

Procedure: autologous hematopoietic cell transplantation