Acute Myeloid LeukemiaPhase 1NCT00861874
A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study testing Decitabine and Rapamycin in people with Acute Myeloid Leukemia, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and feasibility of the combination of decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed or refractory acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Decitabine and Rapamycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2012
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Diagnosis of AML according to WHO criteria except acute promyelocytic leukemia AND
- Refractory AML defined as a failure to achieve CR after 2 cycles of induction chemotherapy or persistence of > 40% bone marrow blasts after one cycle of chemotherapy induction OR
- Relapsed AML defined as any evidence of disease recurrence within 12 months of achieving first CR OR
- Relapsed AML after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent AML
- ECOG performance status <3 (Appendix 1)
Who cannot join
- Abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (Cockcroft-Gault formula (Appendix 2)
- Abnormal liver function: Bilirubin >2.0 mg/dl, transaminase more than 2.5x the upper limits of normal
- Active systemic infection
- Known chronic liver disease
- Known diagnosis of human immunodeficiency virus infection (HIV)
- Patients who are post-allogeneic transplantation should not have active GVHD greater than grade 1 of skin
- Pregnant or breast feeding female subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
The purpose of this study is to determine the safety and feasibility of the combination of decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed or refractory acute myeloid leukemia.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Decitabine, Rapamycin
- 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.
DecitabineDrug
20 mg/m2 IV, Days 1-5
RapamycinDrug
Dose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Decitabine; Drug: Rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of chemotherapy with the drug decitabine combined with rapamycin to determine the highest dose of rapamycin that can be given in combination with decitabine.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Liesveld, University of Rochester
- Investigators
- Jane Liesveld, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861874
- Sponsor's protocol ID
- 26037
- Status last verified
- Oct 2012
- First submitted
- 12 Mar 2009
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liesveld JL, O'Dwyer K, Walker A, Becker MW, Ifthikharuddin JJ, Mulford D, Chen R, Bechelli J, Rosell K, Minhajuddin M, Jordan CT, Phillips GL 2nd. A phase I study of decitabine and rapamycin in relapsed/refractory AML. Leuk Res. 2013 Dec;37(12):1622-7. doi: 10.1016/j.leukres.2013.09.002. Epub 2013 Sep 8.
PubMed 24138944
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00861874
- Acronym / sponsor ID
- 26037
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- First posted
- 16 Mar 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.
The purpose of this study is to determine the safety and feasibility of the combination of decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed or refractory acute myeloid leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Decitabine, Drug: Rapamycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years
- Diagnosis of AML according to WHO criteria except acute promyelocytic leukemia AND
- Refractory AML defined as a failure to achieve CR after 2 cycles of induction chemotherapy or persistence of > 40% bone marrow blasts after one cycle of chemotherapy induction OR
- Relapsed AML defined as any evidence of disease recurrence within 12 months of achieving first CR OR
- Relapsed AML after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent AML
Key exclusion criteria (7 listed)
- Abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (Cockcroft-Gault formula (Appendix 2)
- Abnormal liver function: Bilirubin >2.0 mg/dl, transaminase more than 2.5x the upper limits of normal
- Active systemic infection
- Known chronic liver disease
- Known diagnosis of human immunodeficiency virus infection (HIV)
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 |
|---|---|---|
| Decitabine20 mg/m2 IV, Days 1-5 | Drug | Treatment |
| RapamycinDose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26 | Drug | Treatment |
Primary outcome
Evaluate the safety of chemotherapy with the drug decitabine combined with rapamycin to determine the highest dose of rapamycin that can be given in combination with decitabine.
Time frame: 6 months
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 10 Oct 2012.
- Derived from this study: PubMed 24138944Liesveld JL, O'Dwyer K, Walker A, Becker MW, Ifthikharuddin JJ, Mulford D, Chen R, Bechelli J, Rosell K, Minhajuddin M, Jordan CT, Phillips GL 2nd. A phase I study of decitabine and rapamycin in relapsed/refractory AML. Leuk Res. 2013 Dec;37(12):1622-7. doi: 10.1016/j.leukres.2013.09.002. Epub 2013 Sep 8.
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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.
Jane Liesveld, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Decitabine and Rapamycin in people with Acute Myeloid Leukemia, run by University of Rochester at 1 site in United States.
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 6 inclusion and 7 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 10 Oct 2012. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaluate the safety of chemotherapy with the drug decitabine combined with rapamycin to determine the highest dose of rapamycin that can be given in combination with decitabine. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00861874, which also lists 1 linked publication.
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 10 Oct 2012.