LeukemiaPhase 2NCT01401322
Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
A Phase 2 study testing Lenalidomide in people with Leukemia and Relapsed Adult Acute Lymphocytic Leukemia, run by Stanford University at 1 site in United States.
Trial summary
Time-to-Progression (TTP) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Relapsed Adult Acute Lymphocytic Leukemia
- What is being tested?
- Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Relapsed or refractory acute lymphoblastic leukemia (ALL) with > 10% bone marrow or peripheral blood blasts per WHO-criteria. Refractory define as failure to achieve CR after prior therapy.
- Previously untreated patients > 60, if not candidates for standard induction
- Age ≥ 18
- Not a candidate for curative treatment regimens
- Unwilling or unable to receive conventional chemotherapy
- ECOG performance status ≤ 2
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- Life expectancy > 2 months
- Registered to in RevAssist restricted distribution program, and willing and able to comply with the program requirement
- Females of childbearing potential (FCBP):
- Must have a negative serum or urine pregnancy test (sensitivity of at least 50 mIU/mL) 10 to 14 days prior to study enrollment and within 24 hours prior to prescribing lenalidomide
- Must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control
- Agree to ongoing pregnancy testing
- Men must agree to use a latex condom during sexual contact with a FCBP
- Able to adhere to the study visit schedule and other protocol requirements
- Willing and able to understand and voluntarily sign a written informed consent
Who cannot join
- Prior therapy with lenalidomide
- History of intolerance to thalidomide including development of erythema nodosum while taking thalidomide or similar drugs
- Advanced malignant hepatic tumors.
- Concomitant treatment with other anti-neoplastic agents (exception hydroxyurea)
- Anti-neoplastic treatment less than 4 weeks prior to enrollment (exception hydroxyurea)
- Use of any other experimental drug or therapy within 14 days of baseline
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- Inability to swallow or absorb drug
- Active opportunistic infection or treatment for opportunistic infection within 4 weeks of first dose of study drug
- New York Heart Association Class III or IV heart failure
- Unstable angina pectoris
- Cardiac arrhythmias with rapid ventricular response (heart rate > 100 beats/minute)
- Uncontrolled psychiatric illness that would limit compliance with requirements
- Known HIV infection
- Known active hepatitis B virus (HBV) (exception seropositivity due to HBV vaccine not considered active HBV)
- Known hepatitis C virus (HCV) infection
- Pregnant
- Lactating females must agree not to breastfeed while taking lenalidomide
- Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation
- Creatinine ≥ 1.5 mg/dL
- Creatinine clearance ≤ 60 mL/min.
- Total bilirubin > 1.5 x institutional upper limit of normal (ULN) (exception documented Gilbert's syndrome)
- AST and ALT > 3 x institutional ULN
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
Time-to-Progression (TTP)
Read the detailed description
Determine the time-to-progression (TTP) for subjects with relapsed/refractory acute lymphoblastic leukemia (ALL) receiving single agent lenalidomide 50 mg/day for 28 days/cycle.
- Being tested
- Lenalidomide
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
50 mg; po
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide 50 mg/day x 28 days | Experimental | Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-Progression (TTP)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionMay 2012
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Principal investigator, Bruno C. Medeiros, Stanford University
- Investigators
- Bruno Carneiro de Medeiros, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401322
- Sponsor's protocol ID
- IRB-19607
- Other IDs
- SU-01142011-7364, RV_ALL_PI_0616, HEMALL0006
- Status last verified
- Oct 2016
- First submitted
- 20 Jul 2011
- Last updated
- 28 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Agent Lenalidomide in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)
- ClinicalTrials.gov ID
- NCT01401322
- Acronym / sponsor ID
- IRB-19607
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 10 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Time-to-Progression (TTP)
Detailed description
Determine the time-to-progression (TTP) for subjects with relapsed/refractory acute lymphoblastic leukemia (ALL) receiving single agent lenalidomide 50 mg/day for 28 days/cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide 50 mg/day x 28 days | Experimental | Drug: LenalidomideLenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Relapsed or refractory acute lymphoblastic leukemia (ALL) with > 10% bone marrow or peripheral blood blasts per WHO-criteria. Refractory define as failure to achieve CR after prior therapy.
- Previously untreated patients > 60, if not candidates for standard induction
- Age ≥ 18
- Not a candidate for curative treatment regimens
- Unwilling or unable to receive conventional chemotherapy
Key exclusion criteria (22 listed)
- Prior therapy with lenalidomide
- History of intolerance to thalidomide including development of erythema nodosum while taking thalidomide or similar drugs
- Advanced malignant hepatic tumors.
- Concomitant treatment with other anti-neoplastic agents (exception hydroxyurea)
- Anti-neoplastic treatment less than 4 weeks prior to enrollment (exception hydroxyurea)
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 |
|---|---|---|
| LenalidomideAlso: Revlimid50 mg; po | Drug | Lenalidomide 50 mg/day x 28 days |
Primary outcome
Time-to-Progression (TTP)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bruno Carneiro de Medeiros principal investigator
Stanford University
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 Lenalidomide in people with Leukemia and Relapsed Adult Acute Lymphocytic Leukemia, run by Stanford University 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 15 inclusion and 22 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 28 Nov 2016. 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 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?
Yes. Results are posted in the registry (first posted 10 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time-to-Progression (TTP) (time frame: 12 weeks). 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 28 Nov 2016.