Leukemia, Myeloid, AcutePhase 2NCT00850304
Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide
A Phase 2 study testing Cytosar and Arsenic trioxide in people with Leukemia, Myeloid, Acute, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Our purpose in this study is to explore the feasibility of treatment of non promyelocytic Acute myeloid leukaemia on elderly patients. We select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- Cytosar and Arsenic trioxide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- Oct 2007to Feb 2008
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients with non promyelocytic AML
- Performance status (ECOG) 3 or 4
Who cannot join
- Age <60 years
- Elevation of AST OR ALT more than ten times above normal
- Serum bilirubin above 5
- Cr level > 2
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hematology-Oncology and SCT Research Center
Tehran, Tehran Province, 14114
About this study
Official title: Feasibility Study of Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide on Ambulatory Schedule
Our purpose in this study is to explore the feasibility of treatment of non promyelocytic Acute myeloid leukaemia on elderly patients. We select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. We will assess overall response rate and overall survival in end of one year.
Read the detailed description
Acute myeloid leukemia is a disease in which characterised by blast further than 20% in bone marrow plus incomplete differentiation. Many of this patients are elderly with age further than 60 years(CALGB,ECOG,EORTC) or 55 years (SWOG). Mortality rate fallowing standard therapy of this patients is high that can reach to 50%. One of methods to apply a remission with least mortality and morbidity and also significant lower cost effects compare to historical and conventional standard regimen is low dose cytosar and arsenic trioxide combination that has been reported complete remission to 34%.
We select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. We will assess overall response rate and overall survival in end of one year.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- Cytosar, Arsenic trioxide
- Keywords
- AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytosarDrug
Cytosar 20 mg /q12h/ sc/10d/q28d for 2 cycle
Arsenic trioxideDrug
Also called ATO
Arsenic trioxide 10mg/infusion2h/iv/DW5% d1-d5,d7-d11
| Study group | Role | What they receive |
|---|---|---|
| Arm one | Experimental | Not described Receives: Drug: Cytosar; Drug: Arsenic trioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: 1, 2, 6 month and one year after intervention
Secondary outcomes (1)
Overall Survival
Measured: One year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startOct 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Kamran Alimoghaddam, M.D., Study director, Hematology-Oncology and SCT Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850304
- Sponsor's protocol ID
- 87-02-36-7242
- Status last verified
- Feb 2009
- First submitted
- 21 Feb 2009
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide on Ambulatory Schedule
- ClinicalTrials.gov ID
- NCT00850304
- Acronym / sponsor ID
- 87-02-36-7242
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 24 Feb 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.
Our purpose in this study is to explore the feasibility of treatment of non promyelocytic Acute myeloid leukaemia on elderly patients. We select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. We will assess overall response rate and overall survival in end of one year.
Detailed description
Acute myeloid leukemia is a disease in which characterised by blast further than 20% in bone marrow plus incomplete differentiation. Many of this patients are elderly with age further than 60 years(CALGB,ECOG,EORTC) or 55 years (SWOG). Mortality rate fallowing standard therapy of this patients is high that can reach to 50%. One of methods to apply a remission with least mortality and morbidity and also significant lower cost effects compare to historical and conventional standard regimen is low dose cytosar and arsenic trioxide combination that has been reported complete remission to 34%.
We select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. We will assess overall response rate and overall survival in end of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm one | Experimental | Drug: Cytosar, Drug: Arsenic trioxide |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elderly patients with non promyelocytic AML
- Performance status (ECOG) 3 or 4
Key exclusion criteria (4 listed)
- Age <60 years
- Elevation of AST OR ALT more than ten times above normal
- Serum bilirubin above 5
- Cr level > 2
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 |
|---|---|---|
| CytosarCytosar 20 mg /q12h/ sc/10d/q28d for 2 cycle | Drug | Arm one |
| Arsenic trioxideAlso: ATOArsenic trioxide 10mg/infusion2h/iv/DW5% d1-d5,d7-d11 | Drug | Arm one |
Primary outcome
Response Rate
Time frame: 1, 2, 6 month and one year after intervention
1 secondary outcome
Overall Survival
Time frame: One year after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
Related trials for Leukemia, Myeloid, Acute
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Kamran Alimoghaddam, M.D. study director
Hematology-Oncology and SCT Research Center
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 Cytosar and Arsenic trioxide in people with Leukemia, Myeloid, Acute, run by Tehran University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 24 Feb 2009. 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 Iran. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response Rate (time frame: 1, 2, 6 month and one year after intervention). 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 24 Feb 2009.