Acute Promyelocytic LeukemiaPhase 2NCT00907582
ASCT for Relapsed APL After Molecular Remission
A Phase 2 study testing autologous hematopoietic cell transplantation in people with Acute Promyelocytic Leukemia and Relapse, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Promyelocytic Leukemia, Relapse
- What is being tested?
- autologous hematopoietic cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, 200025
About this study
Official title: Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning
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).
Read the detailed 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.
- Conditions
- Acute Promyelocytic Leukemia, Relapse
- Being tested
- autologous hematopoietic cell transplantation
- Keywords
- PCR negative
- Medical subject headings
- Leukemia, Promyelocytic, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous hematopoietic cell transplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ASCT in relapsed APL | Experimental | autologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission Receives: Procedure: autologous hematopoietic cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: 3 years
Secondary outcomes (2)
overall survival
Measured: 3 years
transplantation related mortality
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Promyelocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiong HU, Shanghai Jiao Tong University School of Medicine
- Investigators
- JIong HU, M.D., Principal investigator, Shanghai Rui Jin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907582
- Sponsor's protocol ID
- MHOPES-APL09
- Status last verified
- Nov 2014
- First submitted
- 21 May 2009
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning
- ClinicalTrials.gov ID
- NCT00907582
- Acronym / sponsor ID
- MHOPES-APL09
- Conditions
- Acute Promyelocytic Leukemia, Relapse
- Keywords
- PCR negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASCT in relapsed APL | Experimental | Procedure: autologous hematopoietic cell transplantationautologous hematopoietic cell transplantation for patients with relapsed APL after achieving molecular remission |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous hematopoietic cell transplantationAutologous 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. | Procedure or surgery | ASCT in relapsed APL |
Primary outcome
disease free survival
Time frame: 3 years
2 secondary outcomes
overall survival
Time frame: 3 years
transplantation related mortality
Time frame: 3 years
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JIong HU, M.D. principal investigator
Shanghai Rui Jin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous hematopoietic cell transplantation in people with Acute Promyelocytic Leukemia and Relapse, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.