LeukemiaPhase 2NCT01222195
Lenalidomide and Darbepoetin in Low-Intermediate Risk Myelodysplastic Syndrome (MDS)
A Phase 2 study testing Lenalidomide and Darbepoetin alfa in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if lenalidomide and darbepoetin alfa given together will help to control the need for transfusions in patients with low to intermediate risk Myelodysplastic Syndrome (MDS). The safety of this combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Lenalidomide and Darbepoetin alfa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 2010
- 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
- Understand and voluntarily sign an informed consent form.
- Age >/=18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Have low or intermediate-1 IPSS risk category MDS (excluding 5q deletion)
- red blood cell (RBC) transfusion-dependent anemia defined as no transfusion free interval of >/= 56 consecutive days within the past 112 days.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at study entry.
Show all 11Show fewer
- Laboratory test results within these ranges: Serum creatinine </= 1.5 mg/dL ,Total bilirubin </= 1.5 mg/dL ,AST (SGOT) and ALT (SGPT) </= 3 x ULN, ANC >/= 500 /uL, Platelet count >/= 30,000/uL (untransfused)
- Disease free of prior malignancies for >/=2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
- Patients who are on epoetin alfa or darbepoetin prior to enrollment will be allowed to enroll if they have failed such therapy, failure defined as transfusion requiring despite >/= 6 weeks of epoetin alfa at dose of 40,000 units/week and darbepoetin alfa at dose of 150 mcg/ 2 week. No washout period will be necessary. Upon study entry patients receiving epoetin alfa will be switched over to darbepoetin.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of prescribing lenalidomide 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 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
- continued from #10 Men must agree to use a latex condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy.
Who cannot join
- Clinically significant anemia owing to iron, B12, or folate deficiencies.
- 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)
- Concomitant use of steroids will not be allowed unless used for premedication in preparation for transfusions, treatment of hypersensitivity reaction related to lenalidomide or any underlying medical condition other than MDS (e.g. Chronic Obstructive Pulmonary Disease (COPD)).
- 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 28 days of baseline.
Show all 13Show fewer
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis, type A, B or C.
- Hypersensitivity to darbepoetin or any component of the formulation (including polysorbate 80 and/or albumin);
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Lenalidomide and Darbepoetin Alfa in Myelodysplastic Syndrome (Low to Intermediate-1 Risk Category Excluding 5q Deletion)
The goal of this clinical research study is to learn if lenalidomide and darbepoetin alfa given together will help to control the need for transfusions in patients with low to intermediate risk Myelodysplastic Syndrome (MDS). The safety of this combination will also be studied.
Read the detailed description
Lenalidomide is designed to change the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. Darbepoetin alfa is designed to stimulate production of red blood cells.
If you are found to be eligible to take part in this study, you will take lenalidomide once a day by mouth on Days 1-21. On Days 22-28, you will not take lenalidomide. Swallow lenalidomide capsules whole with water at the same time each day. Do not break, chew or open the capsules.
If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).
Due to the uncertain amount of re-absorption of lenalidomide, there will be no re-dose for lenalidomide if you vomit the pills.
Every 28 days is called a study "cycle". Since lenalidomide may cause blood clots, you will take aspirin every day, by mouth, unless your platelet count is too low. Darbepoetin alfa will be given through a needle under the skin (subcutaneously) once every 2 weeks.
You will be given a drug diary. In this diary, you will record when you take the study drugs and any side effects you may have.
During Cycle 1, you will have a study visit just before receiving lenalidomide and then once a month for the first 3 months, then every 3 months after that. At these visits, you will have a physical exam. Blood (about 2 tablespoons) will be drawn for routine tests. Your drug diary will be checked and you will return the bottle of the study drug and any unused drug. You will receive one cycle supply of lenalidomide.
At the end of the first 3 cycles, or earlier if your doctor thinks it is necessary, you will have a bone marrow aspirate. If your doctor thinks it is necessary, you may have additional bone marrow aspirates while on study.
You may remain on study for as long as you are benefitting. You will be taken off study if the disease gets worse or intolerable side effects occur.
Once you are off-study, you will have an end-of-study visit. At this visit, blood (about 2 tablespoons) will be drawn for routine tests. If you are a woman who is able to have children, a portion of this blood will be used for a blood pregnancy test.
You will be contacted by phone 30 days after you are taken off study, and then every 3 months. You will be asked about any side effects you are experiencing, any new treatments you are having, and if you have needed any blood products. The phone call should take about 10 minutes.
This is an investigational study. Lenalidomide is FDA approved and commercially available. Lenalidomide is approved for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with the chromosome 5 abnormality with or without other chromosome abnormalities. Lenalidomide is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma that have received at least one prior therapy. Its use in this study is investigational. Darbepoetin alfa is approved by FDA for treatment of low red blood cell in patients with cancer and kidney disease. The use of these drugs together is considered to be investigational. Up to 39 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Leukemia
- Being tested
- Lenalidomide, Darbepoetin alfa
- Keywords
- Myelodysplastic Syndrome, Red cell transfusion independence, Darbepoetin alfa, Lenalidomide, CC-5013, Revlimid, Aranesp, Erythropoietin, Erythropoiesis Stimulating Protein
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called CC-5013, Revlimid
10 mg/day by mouth on days 1-21 of every 28 day cycle.
Darbepoetin alfaDrug
Also called Aranesp, Erythropoietin, Erythropoiesis Stimulating Protein
200 mcg subcutaneously every 2 weeks of a 28 cycle.
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide + Darbepoetin alfa | Experimental | Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle Receives: Drug: Lenalidomide; Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With a Transfusion Independence Response
Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.
Measured: Over six 28-day cycles (approximately 168 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startFeb 2008
- Primary completionJul 2010
- Study completionJul 2010
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 M.D. Anderson Cancer CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Gautam Borthakur, MBBS, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222195
- Sponsor's protocol ID
- 2006-0657
- Status last verified
- Aug 2012
- First submitted
- 14 Oct 2010
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Lenalidomide and Darbepoetin Alfa in Myelodysplastic Syndrome (Low to Intermediate-1 Risk Category Excluding 5q Deletion)
- ClinicalTrials.gov ID
- NCT01222195
- Acronym / sponsor ID
- 2006-0657
- Conditions
- Leukemia
- Keywords
- Myelodysplastic Syndrome, Red cell transfusion independence, Darbepoetin alfa, Lenalidomide, CC-5013, Revlimid, Aranesp, Erythropoietin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Feb 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Posted 26 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if lenalidomide and darbepoetin alfa given together will help to control the need for transfusions in patients with low to intermediate risk Myelodysplastic Syndrome (MDS). The safety of this combination will also be studied.
Detailed description
Lenalidomide is designed to change the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. Darbepoetin alfa is designed to stimulate production of red blood cells.
If you are found to be eligible to take part in this study, you will take lenalidomide once a day by mouth on Days 1-21. On Days 22-28, you will not take lenalidomide. Swallow lenalidomide capsules whole with water at the same time each day. Do not break, chew or open the capsules.
If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).
Due to the uncertain amount of re-absorption of lenalidomide, there will be no re-dose for lenalidomide if you vomit the pills.
Every 28 days is called a study "cycle". Since lenalidomide may cause blood clots, you will take aspirin every day, by mouth, unless your platelet count is too low. Darbepoetin alfa will be given through a needle under the skin (subcutaneously) once every 2 weeks.
You will be given a drug diary. In this diary, you will record when you take the study drugs and any side effects you may have.
During Cycle 1, you will have a study visit just before receiving lenalidomide and then once a month for the first 3 months, then every 3 months after that. At these visits, you will have a physical exam. Blood (about 2 tablespoons) will be drawn for routine tests. Your drug diary will be checked and you will return the bottle of the study drug and any unused drug. You will receive one cycle supply of lenalidomide.
At the end of the first 3 cycles, or earlier if your doctor thinks it is necessary, you will have a bone marrow aspirate. If your doctor thinks it is necessary, you may have additional bone marrow aspirates while on study.
You may remain on study for as long as you are benefitting. You will be taken off study if the disease gets worse or intolerable side effects occur.
Once you are off-study, you will have an end-of-study visit. At this visit, blood (about 2 tablespoons) will be drawn for routine tests. If you are a woman who is able to have children, a portion of this blood will be used for a blood pregnancy test.
You will be contacted by phone 30 days after you are taken off study, and then every 3 months. You will be asked about any side effects you are experiencing, any new treatments you are having, and if you have needed any blood products. The phone call should take about 10 minutes.
This is an investigational study. Lenalidomide is FDA approved and commercially available. Lenalidomide is approved for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with the chromosome 5 abnormality with or without other chromosome abnormalities. Lenalidomide is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma that have received at least one prior therapy. Its use in this study is investigational. Darbepoetin alfa is approved by FDA for treatment of low red blood cell in patients with cancer and kidney disease. The use of these drugs together is considered to be investigational. Up to 39 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide + Darbepoetin alfa | Experimental | Drug: Lenalidomide, Drug: Darbepoetin alfaLenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Understand and voluntarily sign an informed consent form.
- Age >/=18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Have low or intermediate-1 IPSS risk category MDS (excluding 5q deletion)
- red blood cell (RBC) transfusion-dependent anemia defined as no transfusion free interval of >/= 56 consecutive days within the past 112 days.
Key exclusion criteria (13 listed)
- Clinically significant anemia owing to iron, B12, or folate deficiencies.
- 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)
- Concomitant use of steroids will not be allowed unless used for premedication in preparation for transfusions, treatment of hypersensitivity reaction related to lenalidomide or any underlying medical condition other than MDS (e.g. Chronic Obstructive Pulmonary Disease (COPD)).
- 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.
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: CC-5013, Revlimid10 mg/day by mouth on days 1-21 of every 28 day cycle. | Drug | Lenalidomide + Darbepoetin alfa |
| Darbepoetin alfaAlso: Aranesp, Erythropoietin, Erythropoiesis Stimulating Protein200 mcg subcutaneously every 2 weeks of a 28 cycle. | Drug | Lenalidomide + Darbepoetin alfa |
Primary outcome
Number of Patients With a Transfusion Independence Response
Time frame: Over six 28-day cycles (approximately 168 days)
Response defined as transfusion independence (no red blood cell transfusions) for at least 8 weeks, anytime during the six 28-day cycles of therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous 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
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.
Gautam Borthakur, MBBS principal investigator
UT MD Anderson Cancer 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 Lenalidomide and Darbepoetin alfa in people with Leukemia, run by M.D. Anderson Cancer Center 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 11 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 7 Aug 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 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 26 Apr 2011). 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?
Number of Patients With a Transfusion Independence Response (time frame: Over six 28-day cycles (approximately 168 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 7 Aug 2012.