Trial record 9 of 115 for:
"Acute promyelocytic leukemia"
Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning
This study is currently recruiting participants.
Verified September 2011 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00907582
First received: May 21, 2009
Last updated: September 15, 2011
Last verified: September 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Promyelocytic Leukemia Relapse |
Procedure: autologous hematopoietic cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning |
Resource links provided by NLM:
Genetics Home Reference related topics:
acute promyelocytic leukemia
familial acute myeloid leukemia with mutated CEBPA
MedlinePlus related topics:
Leukemia
U.S. FDA Resources
Further study details as provided by Shanghai Jiao Tong University School of Medicine:
Primary Outcome Measures:
- disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- transplantation related mortality [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ASCT |
Procedure: autologous hematopoietic cell transplantation
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. |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907582
Contacts
| Contact: Jiong HU, M.D. | 86-21-64370045 ext 601818 | hujiong@medmail.com.cn |
Locations
| China | |
| Rui Jin Hospital, Shanghai JiaoTong University School of Medicine | Recruiting |
| Shanghai, China, 200025 | |
| Contact: Wei Tang, M.D. 86-21-64370045 ext 601818 weiwei_tang@yahoo.com | |
| Principal Investigator: Jiong HU, M.D. | |
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
More Information
No publications provided
| Responsible Party: | Jiong HU, Head, Blood and Marrow Transplantation Center, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00907582 History of Changes |
| Other Study ID Numbers: | MHOPES-APL09 |
| Study First Received: | May 21, 2009 |
| Last Updated: | September 15, 2011 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Shanghai Jiao Tong University School of Medicine:
|
PCR negative |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Promyelocytic, Acute Recurrence Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid, Acute Leukemia, Myeloid Disease Attributes Pathologic Processes Busulfan Idarubicin |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013