Acute LeukemiaPhase 1NCT01615042
Phase I Study of Lenalidomide in Patients With Acute Leukemia
A Phase 1 study testing Lenalidomide in people with Acute Leukemia, run by Mehrdad Abedi, MD at 1 site in United States.
Trial summary
Lenalidomide is a drug that alters the immune system and it may also be directly toxic to tumor. Therefore, in theory, it may reduce or prevent the growth of cancer cells or directly kill them. We will be studying how lenalidomide can be used to decrease bone marrow blast cells in preparation for a bone transplant. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to May 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign an informed consent form.
- Between 18 and 80 years of age at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Non-M3 Acute Myeloid Leukemia with the presence of residual disease in the bone marrow on day 14-28 post induction (or re-induction) chemotherapy. Day 14-28 residual disease is defined in this study as the presence of more than 10 % blasts in the marrow, presence of between 5-10% blasts cells that are not in cluster in hypocellular marrow is ambiguous and bone marrow biopsy should be repeated in 5-7 days.
- Patient should have an already identified sibling, matched unrelated donor or cord blood donor at the time of enrollment to this clinical trial.
- Eastern Cooperative Oncology Group (ECOG) performance status of equal or less than 3 at study entry (this patient population is typically admitted and is in the hospital)
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- Laboratory test results within defined ranges
- Disease free of other malignancies beside the acute myeloid leukemia (AML) for greater than or equal to 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- Females of childbearing potential (FCBP)must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide prescriptions must be filled within 7 days as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females (Lactating females must agree not to breast feed while taking lenalidomide).
- Patients younger than 50 years old, after first induction of chemotherapy, who are able to safely tolerate re-induction therapy with high dose chemotherapy are not eligible for this study.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 14 days of baseline.
- Known hypersensitivity to thalidomide or lenalidomide (if applicable).
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- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Known sero-positive for active viral infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus. Patients who are sero-positive because of hepatitis B virus vaccine are eligible.
- Patients who are not able to swallow the lenalidomide capsule as a whole are excluded from this study.
- Patients with impaired gastrointestinal absorption
- Symptomatic congestive heart failure
- Unstable angina pectoris or cardiac arrhythmia
- History of adrenal insufficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Comprehensive Cancer Center
Sacramento, California, 95817
About this study
Official title: Phase I Trial of High Dose Lenalidomide in Patients With Refractory/Relapsed Acute Leukemia as a Bridge to Bone Marrow Transplant
Lenalidomide is a drug that alters the immune system and it may also be directly toxic to tumor. Therefore, in theory, it may reduce or prevent the growth of cancer cells or directly kill them. We will be studying how lenalidomide can be used to decrease bone marrow blast cells in preparation for a bone transplant.
Read the detailed description
We hypothesize that lenalidomide in high doses can be used to decrease bone marrow blast count in patients with relapsed or refractory acute myeloid leukemia in preparation for an allogeneic stem cell transplant with acceptable toxicities that are no worse than current cytotoxic chemotherapeutic agents. The known dose-limiting toxicity at 75 mg was excessive fatigue in a previous phase I trial which in this study may be irrelevant as all study participants will have an in-patient status.
- Conditions
- Acute Leukemia
- Being tested
- Lenalidomide
- Keywords
- Acute Leukemia, Bone Marrow Transplant, High Dose Lenalidomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
Oral capsule, daily, 50mg-100mg, one cycle (21 days)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation/High Dose Lenalidomide | Experimental | Subjects are given a single dose of the drug while they are observed and tested for a period of time. If they do not exhibit any adverse side effects the dose is escalated, and a new group of subjects is then given a higher dose. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (measured by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0)
All patients who receive the study drug will be followed closely and evaluated for toxicity.
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE
Measured: One Cycle (21 days)
Secondary outcomes (3)
Rates of complete response (CR) and complete response without platelet recovery (CRi)
Patients will be assessed for the efficacy (CR or CRi) if they have received at least 7 continuous days of study drug.
Measured: One Cycle (21 days)
Pharmacokinetics of high-dose lenalidomide cell activity.
Plasma concentrations of lenalidomide will be studied
Measured: At 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dose on day 1, as well as before morning dosing on days 8, 15, and 21 during the clinical therapy
Define the effects of lenalidomide on T and Natural Killer (NK) cell activity.
Blood samples will be drawn and will be tested for NK cell and T cell activity.
Measured: Baseline and at two weeks after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehrdad Abedi, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor-investigator, Mehrdad Abedi, MD, University of California, Davis
- Investigators
- Mehrdad Abedi, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615042
- Sponsor's protocol ID
- 318008
- Other IDs
- UCDCC#228, RV_AML_PI_0696
- Status last verified
- May 2020
- First submitted
- 6 Jun 2012
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of High Dose Lenalidomide in Patients With Refractory/Relapsed Acute Leukemia as a Bridge to Bone Marrow Transplant
- ClinicalTrials.gov ID
- NCT01615042
- Acronym / sponsor ID
- 318008
- Conditions
- Acute Leukemia
- Keywords
- Acute Leukemia, Bone Marrow Transplant, High Dose Lenalidomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mehrdad Abedi, MDUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Aug 2012 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 8 Jun 2012 (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.
Lenalidomide is a drug that alters the immune system and it may also be directly toxic to tumor. Therefore, in theory, it may reduce or prevent the growth of cancer cells or directly kill them. We will be studying how lenalidomide can be used to decrease bone marrow blast cells in preparation for a bone transplant.
Detailed description
We hypothesize that lenalidomide in high doses can be used to decrease bone marrow blast count in patients with relapsed or refractory acute myeloid leukemia in preparation for an allogeneic stem cell transplant with acceptable toxicities that are no worse than current cytotoxic chemotherapeutic agents. The known dose-limiting toxicity at 75 mg was excessive fatigue in a previous phase I trial which in this study may be irrelevant as all study participants will have an in-patient status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation/High Dose Lenalidomide | Experimental | Drug: LenalidomideSubjects are given a single dose of the drug while they are observed and tested for a period of time. If they do not exhibit any adverse side effects the dose is escalated, and a new group of subjects is then given a higher dose. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Understand and voluntarily sign an informed consent form.
- Between 18 and 80 years of age at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Non-M3 Acute Myeloid Leukemia with the presence of residual disease in the bone marrow on day 14-28 post induction (or re-induction) chemotherapy. Day 14-28 residual disease is defined in this study as the presence of more than 10 % blasts in the marrow, presence of between 5-10% blasts cells that are not in cluster in hypocellular marrow is ambiguous and bone marrow biopsy should be repeated in 5-7 days.
- Patient should have an already identified sibling, matched unrelated donor or cord blood donor at the time of enrollment to this clinical trial.
Key exclusion criteria (13 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females (Lactating females must agree not to breast feed while taking lenalidomide).
- Patients younger than 50 years old, after first induction of chemotherapy, who are able to safely tolerate re-induction therapy with high dose chemotherapy are not eligible for this study.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 14 days of baseline.
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: RevlimidOral capsule, daily, 50mg-100mg, one cycle (21 days) | Drug | Dose Escalation/High Dose Lenalidomide |
Primary outcome
Maximum Tolerated Dose (measured by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0)
Time frame: One Cycle (21 days)
All patients who receive the study drug will be followed closely and evaluated for toxicity. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE
3 secondary outcomes
Rates of complete response (CR) and complete response without platelet recovery (CRi)
Time frame: One Cycle (21 days)
Pharmacokinetics of high-dose lenalidomide cell activity.
Time frame: At 0.25, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dose on day 1, as well as before morning dosing on days 8, 15, and 21 during the clinical therapy
Define the effects of lenalidomide on T and Natural Killer (NK) cell activity.
Time frame: Baseline and at two weeks after therapy
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- University of California Davis Comprehensive Cancer Center WebsiteLink provided by the sponsor.
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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.
Mehrdad Abedi, MD principal investigator
University of California, Davis
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 Lenalidomide in people with Acute Leukemia, run by Mehrdad Abedi, MD 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 10 inclusion and 13 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 May 2020. 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 was stopped early (reason given: Lack of enrollment). 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?
Maximum Tolerated Dose (measured by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0) (time frame: One Cycle (21 days)). 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 May 2020.