LeukemiaPhase 1/2NCT01038635
5-Azacytidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
A Phase 1/2 study testing 5-Azacytidine and Lenalidomide in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination with azacitidine to patients with MDS or AML. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia
- What is being tested?
- 5-Azacytidine and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Nov 2015
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with higher risk MDS (bone marrow blasts >/= 10% to 30% inclusive) of any age who refuse or are not eligible for frontline chemotherapy.
- No prior therapy for higher risk MDS as defined above.
- Performance status of </= 2 by the Eastern Cooperative Oncology Group (ECOG) scale.
- Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of University of Texas MD Anderson Cancer Center (UTMDACC).
- Hydroxyurea for patients with rapidly proliferative disease can be used up to 24 hours prior to therapy but not concomitantly with 5-azacitidine or lenalidomide. Hydroxyurea can be used once the patient has completed the planned 5 azacitidine and lenalidomide treatment.
- Adequate liver function: Total bilirubin of </= 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) </= 3 x ULN
Show all 12Show fewer
- Renal function - assessed by calculated creatinine clearance as follows (see Appendix: Cockcroft-Gault estimation of CrCl): 1. Phase I subjects must have calculated creatinine clearance >/= 60ml/min by Cockcroft-Gault formula. 2. Phase II subjects must have calculated creatinine clearance >/= 30ml/min by Cockcroft-Gault formula.
- All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of Revlimid REMS®.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
- 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 (prescriptions must be filled within 7 days) 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.
- Continued from #9: 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
- Nursing and pregnant females.
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Patients with advanced malignant hepatic tumors.
- Unwilling or unable to remain in compliance with the RevAssist® program
- Known hypersensitivity to thalidomide or lenalidomide (if applicable).
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I/II Study of the Combination of 5-azacitidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination with azacitidine to patients with MDS or AML.
The goal of Phase 2 of this study is to learn if the combination dose of azacitidine and lenalidomide found in Phase 1 can help to control MDS and/or AML.
The safety of this drug combination will be studied in both Phases.
Read the detailed description
The Study Drugs:
Azacitidine is designed to block certain proteins that stop the function of tumor-fighting genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.
Lenalidomide is designed to change the immune system. 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.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 6 groups of 3-6 participants will be enrolled in the Phase 1 portion of the study, and up to 40 participants will be enrolled in Phase 2.
If you are enrolled in the Phase 1 portion, the dose of lenalidomide you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of lenalidomide. Each new group will receive a higher dose of lenalidomide than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of lenalidomide is found.
If you are enrolled in the Phase 2 portion, you will receive lenalidomide at the highest dose that was tolerated in the Phase 1 portion.
All participants will receive the same dose level of azacitidine.
Study Drug Administration:
Each study "cycle" will be about 3-8 weeks, depending on how well you tolerate the drugs, any side effects that you may have, and how your blood count and bone marrow recovers.
On Days 1-5 of every cycle, you will receive azacitidine by vein over 15-30 minutes.
In order to participate in this study you must register into and follow the requirements of the Revlimid REMS™ program of Celgene Corporation. This program provides education and counseling on the risks of fetal exposure, blood clots and reduced blood counts. You will be required to receive counseling every 28 days during treatment with lenalidomide, follow the pregnancy testing and birth control requirements of the program that are appropriate for you and take telephone surveys regarding your compliance with the program.
If you are enrolled in Phase 2 of the study, on Days 6-15 of every cycle, you will take capsules of lenalidomide by mouth.
You should swallow lenalidomide capsules whole with a cup (about 8 ounces) of 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). If you take more than the prescribed dose of lenalidomide, you should seek emergency medical care if needed and contact study staff right away. Any unused lenalidomide should be returned as instructed through the RevAssist® program.
Any woman who can become pregnant should wear gloves if touching the lenalidomide capsules.
You have been informed of the risk of birth defects. If you are female, you agree not to become pregnant while taking lenalidomide. For this reason, lenalidomide is provided to patients under a special distribution program called Revlimid REMSTM.
Your dose of study drugs may be lowered if you experience side effects.
You may be given drugs to help prevent side effects, such as nausea, vomiting, and/or diarrhea. The doctor will tell you more about what drugs you may receive.
Study Visits:
At every study visit, you will be asked about any other drugs and/or treatments you may be receiving and about any side effects you may be having.
One (1) time during each week of Cycle 1:
- Your medical history will be recorded.
- You will have a physical exam.
- Blood (about 1-2 tablespoons) will be drawn for routine tests.
On Days 21 and 28 of Cycle 1 (+/- 3 days), you will have a bone marrow aspiration performed to check the status of the disease. You will then have a bone marrow aspiration performed every 7-14 days for the rest of the study. If at any point the disease appears to go into remission, you will then have a bone marrow aspiration performed every 1-3 cycles.
Before Day 1 of Cycles 2 and beyond:
- Your medical history will be recorded.
- You will have a physical exam.
- Blood (about 1-2 tablespoons) will be drawn for routine tests.
Pregnancy Testing:
If you are a woman who is able to become pregnant, you will have blood (about 1-2 tablespoons) or urine pregnancy tests 1 time a week for the first 4 weeks of the study, then every 4 weeks while on study, when you stop the study, and 4 weeks after you are off study.
If you are a woman who is able to become pregnant and your menstrual cycles are irregular, you will have blood (about 1-2 tablespoons) or urine pregnancy test 1 time a week for the first 4 weeks, then every 2 weeks while on study, when you stop the study, and 2 and 4 weeks after you are off study.
Length of Study:
You may continue to receive azacitidine as long as the doctor thinks it is in your best interest. You may receive lenalidomide as part of this study for as long as you are benefitting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
This is an investigational study. Both azacitidine and lenalidomide are FDA approved and commercially available for the treatment of MDS. Azacitidine is not FDA approved or commercially available for treatment of AML. The combination as used in this study is investigational.
Up to 88 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Leukemia
- Being tested
- 5-Azacytidine, Lenalidomide
- Keywords
- 5-Azacytidine, 5-Aza, Lenalidomide, Revlimid, CC-5103, Myelodysplastic Syndrome, MDS, Acute Myelogenous Leukemia, AML
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-AzacytidineDrug
Also called 5-AZA, Azacitidine, Vidaza, 5-AZC
75 mg/m^2 IV daily x 5 days on days 1 to 5.
LenalidomideDrug
Also called CC-5013, Revlimid
Starting dose 10 mg orally daily x 5 days on days 6 to 10.
| Study group | Role | What they receive |
|---|---|---|
| 5-Azacytidine + Lenalidomide | Experimental | 5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10. Receives: Drug: 5-Azacytidine; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA)
DLT determined only during first course of therapy, at least 28 days from treatment of last participant before a new dose level initiated. All severe (Grade 3-4) non-hematological toxicities that are drug related considered for DLT determination. If 1 participant develops grade III-IV non-hematological toxicity, 3 more will be accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, the doses of the combination at which this occurs will be considered too toxic. A total of 10 patients will be treated at the maximally tolerated dose (MTD) of the combination (the dose level below that considered to be too toxic) to confirm its tolerability.
Measured: 3-8 week cycles, up to 24 weeks
Secondary outcomes (2)
Overall Response Rate (ORR) of Lenalidomide in Combination With 5-azacytidine (5-AZA) in Participants With Leukemia
Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.
Measured: 6 months
Overall Response: Number of Participants With CR or CRi Response
Response defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRi) for AML or any response for myelodysplastic syndrome (MDS) using international working group (IWG)-06 criteria. Complete response (CR) requires normalization of peripheral counts (absolute neutrophil count 10^9/L or more, platelet count 100 x 10^9/L or more), and a bone marrow with 5% or less marrow blasts. A hematologic improvement (HI) is defined as a CR with a platelet count above 30 x 10^9/L, without the need for transfusion of Platelets.
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 posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionNov 2015
- Study completionNov 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Guillermo Garcia-Manero, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038635
- Sponsor's protocol ID
- 2009-0467
- Other IDs
- NCI-2011-01941
- Status last verified
- Dec 2016
- First submitted
- 23 Dec 2009
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
DiNardo CD, Daver N, Jabbour E, Kadia T, Borthakur G, Konopleva M, Pemmaraju N, Yang H, Pierce S, Wierda W, Bueso-Ramos C, Patel KP, Cortes JE, Ravandi F, Kantarjian HM, Garcia-Manero G. Sequential azacitidine and lenalidomide in patients with high-risk myelodysplastic syndromes and acute myeloid leukaemia: a single-arm, phase 1/2 study. Lancet Haematol. 2015 Jan;2(1):e12-20. doi: 10.1016/S2352-3026(14)00026-X. Epub 2014 Dec 22.
PubMed 26687423
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of the Combination of 5-azacitidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
- ClinicalTrials.gov ID
- NCT01038635
- Acronym / sponsor ID
- 2009-0467
- Conditions
- Leukemia
- Keywords
- 5-Azacytidine, 5-Aza, Lenalidomide, Revlimid, CC-5103, Myelodysplastic Syndrome, MDS, Acute Myelogenous Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Dec 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Posted 10 Feb 2017
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 Phase 1 of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination with azacitidine to patients with MDS or AML.
The goal of Phase 2 of this study is to learn if the combination dose of azacitidine and lenalidomide found in Phase 1 can help to control MDS and/or AML.
The safety of this drug combination will be studied in both Phases.
Detailed description
The Study Drugs:
Azacitidine is designed to block certain proteins that stop the function of tumor-fighting genes. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.
Lenalidomide is designed to change the immune system. 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.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 6 groups of 3-6 participants will be enrolled in the Phase 1 portion of the study, and up to 40 participants will be enrolled in Phase 2.
If you are enrolled in the Phase 1 portion, the dose of lenalidomide you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of lenalidomide. Each new group will receive a higher dose of lenalidomide than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of lenalidomide is found.
If you are enrolled in the Phase 2 portion, you will receive lenalidomide at the highest dose that was tolerated in the Phase 1 portion.
All participants will receive the same dose level of azacitidine.
Study Drug Administration:
Each study "cycle" will be about 3-8 weeks, depending on how well you tolerate the drugs, any side effects that you may have, and how your blood count and bone marrow recovers.
On Days 1-5 of every cycle, you will receive azacitidine by vein over 15-30 minutes.
In order to participate in this study you must register into and follow the requirements of the Revlimid REMS™ program of Celgene Corporation. This program provides education and counseling on the risks of fetal exposure, blood clots and reduced blood counts. You will be required to receive counseling every 28 days during treatment with lenalidomide, follow the pregnancy testing and birth control requirements of the program that are appropriate for you and take telephone surveys regarding your compliance with the program.
If you are enrolled in Phase 2 of the study, on Days 6-15 of every cycle, you will take capsules of lenalidomide by mouth.
You should swallow lenalidomide capsules whole with a cup (about 8 ounces) of 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). If you take more than the prescribed dose of lenalidomide, you should seek emergency medical care if needed and contact study staff right away. Any unused lenalidomide should be returned as instructed through the RevAssist® program.
Any woman who can become pregnant should wear gloves if touching the lenalidomide capsules.
You have been informed of the risk of birth defects. If you are female, you agree not to become pregnant while taking lenalidomide. For this reason, lenalidomide is provided to patients under a special distribution program called Revlimid REMSTM.
Your dose of study drugs may be lowered if you experience side effects.
You may be given drugs to help prevent side effects, such as nausea, vomiting, and/or diarrhea. The doctor will tell you more about what drugs you may receive.
Study Visits:
At every study visit, you will be asked about any other drugs and/or treatments you may be receiving and about any side effects you may be having.
One (1) time during each week of Cycle 1:
- Your medical history will be recorded.
- You will have a physical exam.
- Blood (about 1-2 tablespoons) will be drawn for routine tests.
On Days 21 and 28 of Cycle 1 (+/- 3 days), you will have a bone marrow aspiration performed to check the status of the disease. You will then have a bone marrow aspiration performed every 7-14 days for the rest of the study. If at any point the disease appears to go into remission, you will then have a bone marrow aspiration performed every 1-3 cycles.
Before Day 1 of Cycles 2 and beyond:
- Your medical history will be recorded.
- You will have a physical exam.
- Blood (about 1-2 tablespoons) will be drawn for routine tests.
Pregnancy Testing:
If you are a woman who is able to become pregnant, you will have blood (about 1-2 tablespoons) or urine pregnancy tests 1 time a week for the first 4 weeks of the study, then every 4 weeks while on study, when you stop the study, and 4 weeks after you are off study.
If you are a woman who is able to become pregnant and your menstrual cycles are irregular, you will have blood (about 1-2 tablespoons) or urine pregnancy test 1 time a week for the first 4 weeks, then every 2 weeks while on study, when you stop the study, and 2 and 4 weeks after you are off study.
Length of Study:
You may continue to receive azacitidine as long as the doctor thinks it is in your best interest. You may receive lenalidomide as part of this study for as long as you are benefitting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
This is an investigational study. Both azacitidine and lenalidomide are FDA approved and commercially available for the treatment of MDS. Azacitidine is not FDA approved or commercially available for treatment of AML. The combination as used in this study is investigational.
Up to 88 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-Azacytidine + Lenalidomide | Experimental | Drug: 5-Azacytidine, Drug: Lenalidomide5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with higher risk MDS (bone marrow blasts >/= 10% to 30% inclusive) of any age who refuse or are not eligible for frontline chemotherapy.
- No prior therapy for higher risk MDS as defined above.
- Performance status of </= 2 by the Eastern Cooperative Oncology Group (ECOG) scale.
- Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of University of Texas MD Anderson Cancer Center (UTMDACC).
- Hydroxyurea for patients with rapidly proliferative disease can be used up to 24 hours prior to therapy but not concomitantly with 5-azacitidine or lenalidomide. Hydroxyurea can be used once the patient has completed the planned 5 azacitidine and lenalidomide treatment.
Key exclusion criteria (7 listed)
- Nursing and pregnant females.
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Patients with advanced malignant hepatic tumors.
- Unwilling or unable to remain in compliance with the RevAssist® program
- Known hypersensitivity to thalidomide or lenalidomide (if applicable).
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 |
|---|---|---|
| 5-AzacytidineAlso: 5-AZA, Azacitidine, Vidaza, 5-AZC75 mg/m^2 IV daily x 5 days on days 1 to 5. | Drug | 5-Azacytidine + Lenalidomide |
| LenalidomideAlso: CC-5013, RevlimidStarting dose 10 mg orally daily x 5 days on days 6 to 10. | Drug | 5-Azacytidine + Lenalidomide |
Primary outcome
Number of Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA)
Time frame: 3-8 week cycles, up to 24 weeks
DLT determined only during first course of therapy, at least 28 days from treatment of last participant before a new dose level initiated. All severe (Grade 3-4) non-hematological toxicities that are drug related considered for DLT determination. If 1 participant develops grade III-IV non-hematological toxicity, 3 more will be accrued at that particular dose level. If 2 or more participants develop grade III-IV non-hematologic toxicity, the doses of the combination at which this occurs will be considered too toxic. A total of 10 patients will be treated at the maximally tolerated dose (MTD) of the combination (the dose level below that considered to be too toxic) to confirm its tolerability.
2 secondary outcomes
Overall Response Rate (ORR) of Lenalidomide in Combination With 5-azacytidine (5-AZA) in Participants With Leukemia
Time frame: 6 months
Overall Response: Number of Participants With CR or CRi Response
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26687423DiNardo CD, Daver N, Jabbour E, Kadia T, Borthakur G, Konopleva M, Pemmaraju N, Yang H, Pierce S, Wierda W, Bueso-Ramos C, Patel KP, Cortes JE, Ravandi F, Kantarjian HM, Garcia-Manero G. Sequential azacitidine and lenalidomide in patients with high-risk myelodysplastic syndromes and acute myeloid leukaemia: a single-arm, phase 1/2 study. Lancet Haematol. 2015 Jan;2(1):e12-20. doi: 10.1016/S2352-3026(14)00026-X. Epub 2014 Dec 22.
- University of Texas MD Anderson 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.
Guillermo Garcia-Manero, MD study chair
M.D. 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 1/2 study testing 5-Azacytidine and Lenalidomide 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 12 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 Feb 2017. 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 combined 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.
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 Feb 2017). 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 Dose Limiting Toxicities for Determining Maximum Tolerated Dose (MTD) of Lenalidomide in Combination With 5-azacytidine (5-AZA) (time frame: 3-8 week cycles, up to 24 weeks). 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 NCT01038635, 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 Feb 2017.