LeukemiaPhase 2NCT01446133
Combination of Lenalidomide and Rituximab in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL)
A Phase 2 study testing Rituximab and Lenalidomide in people with Leukemia and Lymphoma, 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 the combination of lenalidomide and rituximab can help to control CLL. The safety of this drug combination will also be studied. Lenalidomide is designed to change the body's immune system. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Rituximab 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
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2011to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age >/-18 at the time of signing of informed consent.Understand and voluntarily sign informed consent.
- Patients with chronic lymphocytic leukemia and untreated disease with indication for treatment that are not candidates or unwilling to receive chemoimmunotherapy, or patients of any age with previously treated CLL/SLL or recurrent disease. Patients with recurrent disease are eligible if they have received prior treatment with purine analog based chemotherapy or chemoimmunotherapy or bendamustine.
- ECOG/WHO performance status of 0-2.
- Adequate renal function indicated by serum creatinine less or equal to 2mg/dL
- Adequate hepatic function indicated as total bilirubin less or equal to 2mg/dL and ALT less or equal to 2 times the upper limit of normal.
- Disease free of prior malignancies for 3 years with exception of current basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in this study as long as they have a reasonable expectation to have been cured with the treatment modality received.
- All study participants must be registered into the mandatory RevAssist program and be willing and able to comply with the program requirements.
- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1. Prescriptions must be filled within 7 days and must either commit to continued abstinence from heterosexual intercourse or use 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
- Known sensitivity to lenalidomide or other thalidomide derivatives or rituximab.
- Documented prolymphocytic leukemia (prolymphocytes more than 55% in the peripheral blood).
- Known positivity for HIV or active hepatitis B or C.
- Pregnant or breast feeding females.
- History of tuberculosis treated within the last five years or recent exposure to tuberculosis.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
- Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months prior to enrollment are not eligible for the study.
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: Combination of Lenalidomide and Rituximab in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL) as Initial Treatment or Subsequent Therapy
The goal of this clinical research study is to learn if the combination of lenalidomide and rituximab can help to control CLL. The safety of this drug combination will also be studied.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.
Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will begin taking the study drugs in 28-day cycles. One time a week during Cycle 1, you will receive rituximab by vein. During Cycle 2, you will not receive rituximab. During Cycles 3-12, you will receive rituximab on Day 1 of Cycles 3-12. Your first dose of rituximab will be given over 6-8 hours. If you tolerate your first dose well, you may receive the next doses over 2-4 hours. If the doctor thinks it is needed, the next doses may given over a longer time.
Starting on Day 9 of Cycle 1, you will begin taking lenalidomide by mouth 1 time a day.
The dose and schedule of lenalidomide may change depending on the side effects you may have. You should swallow lenalidomide capsules whole with a glass (8 ounces) 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 a dose, it should NOT be made up on another day.
During Cycle 1 only, you will take allopurinol by mouth 1 time a day on Days 1-14 to lower the risk of side effects.
Study Visits:
One (1) time a week during the first 5 weeks, blood (about 1 tablespoon) will be drawn for routine tests.
After the first 5 weeks, blood (about 1 tablespoon) will be drawn for routine tests every 2 weeks until the doctor thinks your dose of lenalidomide can stay the same. After that, blood (about 1 tablespoon) will be drawn every 4 weeks for the rest of the study for routine tests.
At the end of Cycles 3, 6, and 12, you will have a bone marrow biopsy and aspiration to check the status of the disease.
If you stay on study past 12 cycles, once every 6 cycles (Cycles 18, 24, 30, and so on), you will have a bone marrow biopsy and aspiration to check the status of the disease.
Blood (about 1 tablespoon) will be drawn more often if the dose of lenalidomide needs to be changed or if you have intolerable side effects.
Pregnancy Testing:
If you are able to become pregnant, you will have a urine or blood (less than 1 teaspoon) pregnancy test 10-14 days and 24 hours before the first dose of lenalidomide, even if you have not had a menstrual period due to treatment of the disease or had only 1 menstrual period in the past 24 months.
If you have regular or no menstrual cycles, you will then have a urine or blood (less than 1 teaspoon) pregnancy test every week for the first 4 weeks, then every 4 weeks while taking lenalidomide, again as soon as you stop taking lenalidomide, and then 28 days after you have stopped taking lenalidomide.
If you have irregular menstrual cycles, you will have a urine or blood (less than 1 teaspoon) pregnancy test every week for the first 4 weeks, then every 2 weeks while taking lenalidomide, again as soon as you stop taking lenalidomide, and then at 14 days and 28 days after you have stopped taking lenalidomide.
Length of Treatment:
You may receive rituximab for up to 12 cycles. You may continue taking lenalidomide for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed your last study drug dose (if you are male) or your last follow-up pregnancy test (if you are female).
This is an investigational study. Lenalidomide and rituximab are FDA approved and commercially available. Lenalidomide is approved for the treatment of multiple myeloma and some myelodysplastic syndromes. Rituximab is approved for the treatment of CLL. The combination of these drugs to treat CLL is investigational.
Up to 120 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Being tested
- Rituximab, Lenalidomide
- Keywords
- Leukemia, Lymphoma, Chronic Lymphocytic Leukemia, CLL, Small Lymphocytic Lymphoma, SLL, Initial Treatment, Subsequent Therapy, Rituximab, Rituxan, Lenalidomide, CC-5013, Revlimid
- Medical subject headings
- Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
375 mg/m2 by vein on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2.
LenalidomideDrug
Also called CC-5013, Revlimid
10 mg/day by mouth daily beginning on Day 9 of cycle 1.
| Study group | Role | What they receive |
|---|---|---|
| Untreated 65 + | Experimental | Patients with untreated SLL/CLL with indications for treatment that are age 65 or older.
Rituximab (375 mg/m2) will be given intravenously on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2. Lenalidomide will be started on Day 9 of cycle 1 at the dose of 10 mg/day and will be continued daily. Treatment duration will be 12 cycles and it will be possible to continue beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response. Receives: Drug: Rituximab; Drug: Lenalidomide |
| Prior Treatment Any Age | Experimental | Patients of any age with previously treated CLL/SLL and recurrent disease.
Rituximab (375 mg/m2) will be given intravenously on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2. Lenalidomide will be started on Day 9 of cycle 1 at the dose of 10 mg/day and will be continued daily. Treatment duration will be 12 cycles and it will be possible to continue beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response. Receives: Drug: Rituximab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Participants evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia [IWCLL] overall response criteria by 6 months of treatment. Bone marrow biopsy and aspiration to check the status of the disease. Responses assessed after 3, 6 and 12 cycles.
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 posted5 Oct 2011 (estimated)
- Study start12 Dec 2011
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Alessandra Ferrajoli, MD,BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446133
- Sponsor's protocol ID
- 2011-0509
- Other IDs
- NCI-2012-01119
- Status last verified
- Jun 2026
- First submitted
- 3 Oct 2011
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Strati P, Takahashi K, Peterson CB, Keating MJ, Thompson PA, Daver NG, Jain N, Burger JA, Estrov Z, O'Brien SM, Kantarjian HM, Wierda WG, Futreal PA, Ferrajoli A. Efficacy and predictors of response of lenalidomide and rituximab in patients with treatment-naive and relapsed CLL. Blood Adv. 2019 May 14;3(9):1533-1539. doi: 10.1182/bloodadvances.2019031336.
PubMed 31076409Takahashi K, Hu B, Wang F, Yan Y, Kim E, Vitale C, Patel KP, Strati P, Gumbs C, Little L, Tippen S, Song X, Zhang J, Jain N, Thompson P, Garcia-Manero G, Kantarjian H, Estrov Z, Do KA, Keating M, Burger JA, Wierda WG, Futreal PA, Ferrajoli A. Clinical implications of cancer gene mutations in patients with chronic lymphocytic leukemia treated with lenalidomide. Blood. 2018 Apr 19;131(16):1820-1832. doi: 10.1182/blood-2017-11-817296. Epub 2018 Jan 22.
PubMed 29358183
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Lenalidomide and Rituximab in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL-SLL) as Initial Treatment or Subsequent Therapy
- ClinicalTrials.gov ID
- NCT01446133
- Acronym / sponsor ID
- 2011-0509
- Keywords
- Leukemia, Lymphoma, Chronic Lymphocytic Leukemia, CLL, Small Lymphocytic Lymphoma, SLL, Initial Treatment, Subsequent Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- 12 Dec 2011 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Oct 2011 (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 goal of this clinical research study is to learn if the combination of lenalidomide and rituximab can help to control CLL. The safety of this drug combination will also be studied.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.
Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will begin taking the study drugs in 28-day cycles. One time a week during Cycle 1, you will receive rituximab by vein. During Cycle 2, you will not receive rituximab. During Cycles 3-12, you will receive rituximab on Day 1 of Cycles 3-12. Your first dose of rituximab will be given over 6-8 hours. If you tolerate your first dose well, you may receive the next doses over 2-4 hours. If the doctor thinks it is needed, the next doses may given over a longer time.
Starting on Day 9 of Cycle 1, you will begin taking lenalidomide by mouth 1 time a day.
The dose and schedule of lenalidomide may change depending on the side effects you may have. You should swallow lenalidomide capsules whole with a glass (8 ounces) 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 a dose, it should NOT be made up on another day.
During Cycle 1 only, you will take allopurinol by mouth 1 time a day on Days 1-14 to lower the risk of side effects.
Study Visits:
One (1) time a week during the first 5 weeks, blood (about 1 tablespoon) will be drawn for routine tests.
After the first 5 weeks, blood (about 1 tablespoon) will be drawn for routine tests every 2 weeks until the doctor thinks your dose of lenalidomide can stay the same. After that, blood (about 1 tablespoon) will be drawn every 4 weeks for the rest of the study for routine tests.
At the end of Cycles 3, 6, and 12, you will have a bone marrow biopsy and aspiration to check the status of the disease.
If you stay on study past 12 cycles, once every 6 cycles (Cycles 18, 24, 30, and so on), you will have a bone marrow biopsy and aspiration to check the status of the disease.
Blood (about 1 tablespoon) will be drawn more often if the dose of lenalidomide needs to be changed or if you have intolerable side effects.
Pregnancy Testing:
If you are able to become pregnant, you will have a urine or blood (less than 1 teaspoon) pregnancy test 10-14 days and 24 hours before the first dose of lenalidomide, even if you have not had a menstrual period due to treatment of the disease or had only 1 menstrual period in the past 24 months.
If you have regular or no menstrual cycles, you will then have a urine or blood (less than 1 teaspoon) pregnancy test every week for the first 4 weeks, then every 4 weeks while taking lenalidomide, again as soon as you stop taking lenalidomide, and then 28 days after you have stopped taking lenalidomide.
If you have irregular menstrual cycles, you will have a urine or blood (less than 1 teaspoon) pregnancy test every week for the first 4 weeks, then every 2 weeks while taking lenalidomide, again as soon as you stop taking lenalidomide, and then at 14 days and 28 days after you have stopped taking lenalidomide.
Length of Treatment:
You may receive rituximab for up to 12 cycles. You may continue taking lenalidomide for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed your last study drug dose (if you are male) or your last follow-up pregnancy test (if you are female).
This is an investigational study. Lenalidomide and rituximab are FDA approved and commercially available. Lenalidomide is approved for the treatment of multiple myeloma and some myelodysplastic syndromes. Rituximab is approved for the treatment of CLL. The combination of these drugs to treat CLL is investigational.
Up to 120 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
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Untreated 65 + | Experimental | Drug: Rituximab, Drug: LenalidomidePatients with untreated SLL/CLL with indications for treatment that are age 65 or older. Rituximab (375 mg/m2) will be given intravenously on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2. Lenalidomide will be started on Day 9 of cycle 1 at the dose of 10 mg/day and will be continued daily. Treatment duration will be 12 cycles and it will be possible to continue beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response. |
| Prior Treatment Any Age | Experimental | Drug: Rituximab, Drug: LenalidomidePatients of any age with previously treated CLL/SLL and recurrent disease. Rituximab (375 mg/m2) will be given intravenously on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2. Lenalidomide will be started on Day 9 of cycle 1 at the dose of 10 mg/day and will be continued daily. Treatment duration will be 12 cycles and it will be possible to continue beyond 12 cycles if there is a significant benefit such as an ongoing Partial Response or Complete Response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >/-18 at the time of signing of informed consent.Understand and voluntarily sign informed consent.
- Patients with chronic lymphocytic leukemia and untreated disease with indication for treatment that are not candidates or unwilling to receive chemoimmunotherapy, or patients of any age with previously treated CLL/SLL or recurrent disease. Patients with recurrent disease are eligible if they have received prior treatment with purine analog based chemotherapy or chemoimmunotherapy or bendamustine.
- ECOG/WHO performance status of 0-2.
- Adequate renal function indicated by serum creatinine less or equal to 2mg/dL
- Adequate hepatic function indicated as total bilirubin less or equal to 2mg/dL and ALT less or equal to 2 times the upper limit of normal.
Key exclusion criteria (7 listed)
- Known sensitivity to lenalidomide or other thalidomide derivatives or rituximab.
- Documented prolymphocytic leukemia (prolymphocytes more than 55% in the peripheral blood).
- Known positivity for HIV or active hepatitis B or C.
- Pregnant or breast feeding females.
- History of tuberculosis treated within the last five years or recent exposure to tuberculosis.
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 |
|---|---|---|
| RituximabAlso: Rituxan375 mg/m2 by vein on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2. | Drug | Prior Treatment Any Age, Untreated 65 + |
| LenalidomideAlso: CC-5013, Revlimid10 mg/day by mouth daily beginning on Day 9 of cycle 1. | Drug | Prior Treatment Any Age, Untreated 65 + |
Primary outcome
Overall Response Rate
Time frame: 6 months
Participants evaluated for response by 2008 International Workshop on Chronic Lymphocytic Leukemia [IWCLL] overall response criteria by 6 months of treatment. Bone marrow biopsy and aspiration to check the status of the disease. Responses assessed after 3, 6 and 12 cycles.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 31076409Strati P, Takahashi K, Peterson CB, Keating MJ, Thompson PA, Daver NG, Jain N, Burger JA, Estrov Z, O'Brien SM, Kantarjian HM, Wierda WG, Futreal PA, Ferrajoli A. Efficacy and predictors of response of lenalidomide and rituximab in patients with treatment-naive and relapsed CLL. Blood Adv. 2019 May 14;3(9):1533-1539. doi: 10.1182/bloodadvances.2019031336.
- Derived from this study: PubMed 29358183Takahashi K, Hu B, Wang F, Yan Y, Kim E, Vitale C, Patel KP, Strati P, Gumbs C, Little L, Tippen S, Song X, Zhang J, Jain N, Thompson P, Garcia-Manero G, Kantarjian H, Estrov Z, Do KA, Keating M, Burger JA, Wierda WG, Futreal PA, Ferrajoli A. Clinical implications of cancer gene mutations in patients with chronic lymphocytic leukemia treated with lenalidomide. Blood. 2018 Apr 19;131(16):1820-1832. doi: 10.1182/blood-2017-11-817296. Epub 2018 Jan 22.
- University of Texas 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.
Alessandra Ferrajoli, MD,BS principal investigator
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 2 study testing Rituximab and Lenalidomide in people with Leukemia and Lymphoma, 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 8 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall Response Rate (time frame: 6 months). 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 NCT01446133, which also lists 2 linked publications.
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 23 Jun 2026.