Acute Myeloid LeukemiaPhase 2NCT00957385
Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients
A Phase 2 study testing Revlimid in people with Acute Myeloid Leukemia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission. 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?
- Revlimid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Acute myeloid leukemia in remission.
- Able to take aspirin 81mgs daily.
Who cannot join
- Pregnant or breast feeding females.
- Known hypersensitivity to thalidomide.
- Any prior use of lenalidomide.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Randomized Phase II Study of Lenalidomide Maintenance Therapy in AML Patients Aged > 60 Years in CR1 or Higher and < 60 Years in CR2 or Higher
The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.
Read the detailed description
At present, the majority of AML patients >60 years of age that achieve CR and thereafter successfully complete further chemotherapy, are not candidates for allogeneic bone marrow transplantation (alloBMT) due to their age. Rather, this group of patients is simply observed until relapse occurs. In this age group, the median duration of CR is only ~10 months. The survival of patients <60 years of age who are not candidates for transplantation (due to donor unavailability), and who are in CR2 or higher is also extremely poor. Several lines of evidence suggest that the immune system - and in particular AML specific CTLs and NK cells - is capable of recognizing and clearing AML cells.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Revlimid
- Keywords
- Leukemia, Remission
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevlimidDrug
Also called Lenalidomide
10mgs PO daily for 21 days of each 28 day cycle. Number of cycles: total of 24 or until subject relapses or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Arm A will receive Revlimid. Receives: Drug: Revlimid |
| B | No intervention | Arm B will not receive Revlimid but an observational arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting
Measured: The 1st interim analysis will be done once all subjects have completed 12 cycles, and the 2nd interim analysis will be done once all subjects have completed treatment.
Secondary outcomes (1)
To determine the toxicity of Revlimid when given in the maintenance setting.
Measured: The 1st interim analysis will be done after all subjects have receieved 12 cycles and the 2nd when all subjects have completed treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startJun 2008
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Andre Schuh, MD.FRCP(C), Principal investigator, University Health Network Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957385
- Sponsor's protocol ID
- RV-AML-PI-166
- Status last verified
- Aug 2009
- First submitted
- 11 Aug 2009
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Lenalidomide Maintenance Therapy in AML Patients Aged > 60 Years in CR1 or Higher and < 60 Years in CR2 or Higher
- ClinicalTrials.gov ID
- NCT00957385
- Acronym / sponsor ID
- RV-AML-PI-166
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Leukemia, Remission
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jun 2008
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Aug 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 if Revlimid will help maintain patients with acute myeloid leukemia in remission.
Detailed description
At present, the majority of AML patients >60 years of age that achieve CR and thereafter successfully complete further chemotherapy, are not candidates for allogeneic bone marrow transplantation (alloBMT) due to their age. Rather, this group of patients is simply observed until relapse occurs. In this age group, the median duration of CR is only ~10 months. The survival of patients <60 years of age who are not candidates for transplantation (due to donor unavailability), and who are in CR2 or higher is also extremely poor. Several lines of evidence suggest that the immune system - and in particular AML specific CTLs and NK cells - is capable of recognizing and clearing AML cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: RevlimidArm A will receive Revlimid. |
| B | No intervention | –Arm B will not receive Revlimid but an observational arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Acute myeloid leukemia in remission.
- Able to take aspirin 81mgs daily.
Key exclusion criteria (3 listed)
- Pregnant or breast feeding females.
- Known hypersensitivity to thalidomide.
- Any prior use of lenalidomide.
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 |
|---|---|---|
| RevlimidAlso: Lenalidomide10mgs PO daily for 21 days of each 28 day cycle. Number of cycles: total of 24 or until subject relapses or unacceptable toxicity develops. | Drug | A |
Primary outcome
To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting
Time frame: The 1st interim analysis will be done once all subjects have completed 12 cycles, and the 2nd interim analysis will be done once all subjects have completed treatment.
1 secondary outcome
To determine the toxicity of Revlimid when given in the maintenance setting.
Time frame: The 1st interim analysis will be done after all subjects have receieved 12 cycles and the 2nd when all subjects have completed treatment.
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 19 Jun 2015.
Related trials for Acute Myeloid Leukemia
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.
Andre Schuh, MD.FRCP(C) principal investigator
University Health Network Princess Margaret 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 Revlimid in people with Acute Myeloid Leukemia, run by University Health Network, Toronto at 1 site in Canada.
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 3 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 19 Jun 2015. 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 Canada. 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?
To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting (time frame: The 1st interim analysis will be done once all subjects have completed 12 cycles, and the 2nd interim analysis will be done once all subjects have completed treatment.). 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 19 Jun 2015.