ASCT for Relapsed APL After Molecular Remission

NCT00907582 | Terminated Phase 2

• 1 other identifier: MHOPES-APL09
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Promyelocytic Leukemia; Relapse

Keywords

PCR negative

Outcome Measures

Primary Outcomes (1)

• disease free survival

  3 years

Secondary Outcomes (2)

• overall survival

  3 years

• transplantation related mortality

  3 years

Study Arms (1)

ASCT in relapsed APL

EXPERIMENTAL

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

Procedure: autologous hematopoietic cell transplantation

Interventions

autologous hematopoietic cell transplantation PROCEDURE

Autologous hematopoietic cell transplantation and condition with the following: idarubicin 15mg/m2•d day -11 and -10; busulfan 0.8mg/kg•q6h day -6 to -3.

ASCT in relapsed APL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, Acute; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• JIong HU, M.D.

  Shanghai Rui Jin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Blood and Marrow Transplantation Center, Rui Jin Hospital

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 22, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

CN (1)