Myelodysplastic SyndromesPhase 2NCT00379912
Azacitidine and Erythropoietin Versus Azacitidine Alone for Patients With Low-Risk Myelodysplastic Syndromes
A Phase 2 study testing Azacitidine, Erythropoietin and Azacitidine (Monotherapy) in people with Myelodysplastic Syndromes, run by Larry Cripe, MD at 9 sites in United States.
Trial summary
This trial is designed to explore a modified dose and schedule of azacitidine in order to more effectively address the needs of patients with low-risk myelodysplastic syndromes (MDS), i.e., to alter the natural history of the disease without excessive toxicity or burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Azacitidine, Erythropoietin and Azacitidine (Monotherapy)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2006to Dec 2008
- 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
- A bone marrow (BM) aspirate and biopsy that demonstrates MDS with less than 11% blasts.
- Conventional metaphase cytogenetics done within 90 days prior to registration for screening.
- Central pathology review, correlative submission and confirmation of diagnosis is required prior to initiation of therapy (see Study Procedure Manual for details of submission). The FAB and WHO classification of MDS and the IPSS score will be determined at time of central pathology review.
- Correlative marrow aspirate obtained.
- To be eligible for randomization, subjects must have documentation of at least 1 of the following:
- A transfusion dependent anemia (defined by a history of two or more episodes of transfusion within a period of 8 weeks).
Show all 14Show fewer
- An untransfused hemoglobin < 10 gm/dl measured on at least two occasions more than 7 days apart in the month prior to randomization.
- Patients must also meet 1 of the following criteria:
- Has not received prior erythropoietin and has a serum erythropoietin level > 200 IU/L within 14 days of randomization.
- Has received prior erythropoietin without clinical benefit in the judgment of the treating physician.
- Adequate iron status defined as serum ferritin > 20 ng/ml and transferrin saturation of > 30% within 90 days prior to randomization.
- Symptoms attributed to the anemia with hemoglobin < 11 g/dL.
- Folate and Vitamin B12 levels within normal limits within 90 days prior to randomization.
- Life expectancy > 6 months as judged by the treating investigator.
Who cannot join
- No known history of intolerance to erythropoietic agents.
- No prior intensive cytotoxic chemotherapy for a myeloid malignancy including MDS.
- Patients with a history of a non-myeloid malignancy with secondary MDS are eligible for study enrollment provided, in the opinion of the treating investigator and the study chair, the anticipated behavior of the non-myeloid malignancy will not interfere with study participation and evaluation of outcome.
- No known or suspected hypersensitivity to azacitidine or mannitol.
- No hepatic tumors.
- No uncontrolled hypertension (defined as a systolic pressure > 160 mmHg and/or a diastolic pressure > 110 mmHg).
Show all 11Show fewer
- No known hypersensitivity to mammalian cell-derived products or human albumin.
- No history of (within 12 months) deep venous thrombosis (DVT), pulmonary embolism (PE), or other venous thrombosis. Prior superficial thrombophlebitis is not an exclusion criterion.
- No history of (within 6 months) cerebrovascular accident ([CVA] includes ischemic, embolic and hemorrhagic), transient ischemic attack (TIA), myocardial ischemia (includes Unstable Angina, Q wave Myocardial Infarction [QwMI] and non-Q wave Myocardial Infarction [NQMI], or other arterial thrombosis.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for a 4-week period thereafter.
- Females with childbearing potential must have a negative pregnancy test within 7 days prior to being randomized. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, 46202
Center for Hematology-Oncology of S Michigan
Jackson, Michigan, 49201
Arnett Cancer Care
Lafayette, Indiana, 47904
Horizon Oncology Center
Lafayette, Indiana, 47905
Medical Consultants, P.C.
Muncie, Indiana, 47303
Methodist Cancer Center
Omaha, Nebraska, 68114
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
About this study
Official title: Phase II Randomized Trial With A Modified Dose & Schedule of Subcutaneously Administered Azacitidine & Erythropoietin v Azacitidine Alone in Patients With Low-Risk Myelodysplastic Syndromes (Less Than 11% Marrow & Peripheral Blood Blasts)
This trial is designed to explore a modified dose and schedule of azacitidine in order to more effectively address the needs of patients with low-risk myelodysplastic syndromes (MDS), i.e., to alter the natural history of the disease without excessive toxicity or burden. The administration of erythropoietin is designed to influence the differentiation of primitive hematopoietic cells in which azacitidine has reversed the abnormal phenotype to red blood cells for patients in whom inadequate production of red blood cells is the major clinical issue.
Read the detailed description
OUTLINE: This is an open label, multi-center, randomized study.
Eligible patients will be randomized to one of two treatment arms:
Arm A (Azacitidine + Erythropoietin)
- Azacitidine Treatment 50 mg/m2 subcutaneously every other day (three times a week) for two consecutive weeks every four weeks. A cycle of therapy is defined as two consecutive weeks of subcutaneous azacitidine administered every other day three times a week (e.g. Monday - Wednesday - Friday) and the time to resolution of any treatment associated toxicity.
- Erythropoietin Treatment Patients who are randomized to Arm A will receive a dose of 60,000IU as a single subcutaneous injection weekly without interruption while enrolled on protocol therapy. The dose should be administered to coincide with the first day of each cycle.
- Protocol therapy may be administered for up to six cycles of therapy.
Arm B (Azacitidine Alone)
- Azacitidine Treatment 50 mg/m2 subcutaneously every other day (three times a week) for two consecutive weeks every four weeks. A cycle of therapy is defined as two consecutive weeks of subcutaneous azacitidine administered every other day three times a week (e.g. Monday - Wednesday - Friday) and the time to resolution of any treatment associated toxicity.
- Protocol therapy may be administered for up to six cycles of therapy.
ECOG performance status 0 to 2
Hematopoietic:
To be eligible for randomization, subjects must have documentation of at least 1 of the following:
- A transfusion dependent anemia (defined by a history of two or more episodes of transfusion within a period of 8 weeks).
- An untransfused hemoglobin < 10 gm/dl measured on at least two occasions more than 7 days apart in the month prior to randomization.
Patients must also meet 1 of the following criteria:
- Has not received prior erythropoietin and has a serum erythropoietin level > 200 IU/L within 14 days of randomization.
- Has received prior erythropoietin without clinical benefit in the judgment of the treating physician.
- Adequate iron status defined as serum ferritin > 20 ng/ml and transferrin saturation of > 30% within 90 days prior to randomization.
- Symptoms attributed to the anemia with hemoglobin < 11 g/dL.
- Folate and Vitamin B12 levels within normal limits within 90 days prior to randomization.
Hepatic:
- SGOT (ALT) level < 2 x ULN within 14 days prior to randomization.
- SGPT (AST) level < 2 x ULN within 14 days prior to randomization.
- Serum total bilirubin level < 2 x ULN within 14 days prior to randomization.
Renal:
- Serum creatine < 1.5 x the upper limit of normal (ULN) within 14 days prior to randomization.
Cardiovascular:
- No uncontrolled hypertension (defined as a systolic pressure > 160 mmHg and/or a diastolic pressure > 110 mmHg).
- No history of (within 12 months) deep venous thrombosis (DVT), pulmonary embolism (PE), or other venous thrombosis. Prior superficial thrombophlebitis is not an exclusion criterion.
- No history of (within 6 months) cerebrovascular accident ([CVA] includes ischemic, embolic, and hemorrhagic), transient ischemic attack (TIA), myocardial ischemia (includes Unstable Angina, Q wave Myocardial Infarction [QwMI], and non-Q wave Myocardial Infarction [NQMI]), or other arterial thrombosis.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Azacitidine, Erythropoietin, Azacitidine (Monotherapy)
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called Vidaza
Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
ErythropoietinDrug
Also called EPO
Erythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy
Azacitidine (Monotherapy)Drug
Also called Vidaza
Azacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Arm A | Experimental | Azacitidine + Erythropoietin Receives: Drug: Azacitidine; Drug: Erythropoietin |
| Investigational Arm B | Experimental | Azacitidine Receives: Drug: Azacitidine (Monotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response After Cycle 3
Overall response for participants who have completed at least three cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.
Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements.
Measured: 3 months
Overall Response Rate After Six Cycles
Overall response rate for participants who have completed at least six cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence.
Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements.
Measured: 6 months
Secondary outcomes (6)
Safety Profile of the Modified Dose/Schedule of Azacitidine and Erythropoietin or a Modified Dose of Azacitidine Alone
Full adverse event information is submitted in the record below. A summary of the Significant Toxicities Rate (clinically significant myelosuppression (CTCAE Grade 3 or 4 neutropenia or thrombocytopenia)) over all patients receiving at least 1 dose of study medication at the time of interim analysis is reported in this outcome measure.
Measured: 24 months
Duration of Significant Responses
Data for this outcome measure was not collected or analyzed due to the termination of the study.
Measured: 24 months
Quality of Life
Data for this outcome measure was not collected or analyzed due to the termination of the study
Measured: 24 months
Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
Measured: 6 months
Percent Apoptosis in 34+36+71+ Cells at Baseline, Three Cycles and Six Cycles
Measured: Six months
BclXL Expression
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Insufficient response rate
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 Myelodysplastic SyndromesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larry Cripe, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Ortho Biotech Clinical Affairs, L.L.C., Walther Cancer Institute
- Responsible party
- Sponsor-investigator, Larry Cripe, MD, Hoosier Cancer Research Network
- Investigators
- Larry Cripe, M.D., Study chair, Hoosier Oncology Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379912
- Sponsor's protocol ID
- HOG MDS04-85
- Status last verified
- Jan 2018
- First submitted
- 21 Sep 2006
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sayar H, Chan RJ, Orschell CM, Chan EM, Yu Z, Hood D, Plett A, Yang Z, Hui CL, Nabinger SC, Kohlbacher KJ, West ES, Walter A, Sampson C, Wu J, Cripe LD. Thrice weekly azacitidine does not improve hematological responses in lower-risk myelodysplastic syndromes: a study of the Hoosier Oncology Group. Leuk Res. 2011 Aug;35(8):1108-10. doi: 10.1016/j.leukres.2011.02.025. Epub 2011 Mar 21.
PubMed 21420732
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial With A Modified Dose & Schedule of Subcutaneously Administered Azacitidine & Erythropoietin v Azacitidine Alone in Patients With Low-Risk Myelodysplastic Syndromes (Less Than 11% Marrow & Peripheral Blood Blasts)
- ClinicalTrials.gov ID
- NCT00379912
- Acronym / sponsor ID
- HOG MDS04-85
- Conditions
- Myelodysplastic Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient response rate
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Larry Cripe, MDUniversity, hospital or other
- Collaborators
- Celgene Corporation, Ortho Biotech Clinical Affairs, L.L.C., Walther Cancer Institute
- Study start
- Sep 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Sep 2006 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed to explore a modified dose and schedule of azacitidine in order to more effectively address the needs of patients with low-risk myelodysplastic syndromes (MDS), i.e., to alter the natural history of the disease without excessive toxicity or burden. The administration of erythropoietin is designed to influence the differentiation of primitive hematopoietic cells in which azacitidine has reversed the abnormal phenotype to red blood cells for patients in whom inadequate production of red blood cells is the major clinical issue.
Detailed description
OUTLINE: This is an open label, multi-center, randomized study.
Eligible patients will be randomized to one of two treatment arms:
Arm A (Azacitidine + Erythropoietin)
- Azacitidine Treatment 50 mg/m2 subcutaneously every other day (three times a week) for two consecutive weeks every four weeks. A cycle of therapy is defined as two consecutive weeks of subcutaneous azacitidine administered every other day three times a week (e.g. Monday - Wednesday - Friday) and the time to resolution of any treatment associated toxicity.
- Erythropoietin Treatment Patients who are randomized to Arm A will receive a dose of 60,000IU as a single subcutaneous injection weekly without interruption while enrolled on protocol therapy. The dose should be administered to coincide with the first day of each cycle.
- Protocol therapy may be administered for up to six cycles of therapy.
Arm B (Azacitidine Alone)
- Azacitidine Treatment 50 mg/m2 subcutaneously every other day (three times a week) for two consecutive weeks every four weeks. A cycle of therapy is defined as two consecutive weeks of subcutaneous azacitidine administered every other day three times a week (e.g. Monday - Wednesday - Friday) and the time to resolution of any treatment associated toxicity.
- Protocol therapy may be administered for up to six cycles of therapy.
ECOG performance status 0 to 2
Hematopoietic:
To be eligible for randomization, subjects must have documentation of at least 1 of the following:
- A transfusion dependent anemia (defined by a history of two or more episodes of transfusion within a period of 8 weeks).
- An untransfused hemoglobin < 10 gm/dl measured on at least two occasions more than 7 days apart in the month prior to randomization.
Patients must also meet 1 of the following criteria:
- Has not received prior erythropoietin and has a serum erythropoietin level > 200 IU/L within 14 days of randomization.
- Has received prior erythropoietin without clinical benefit in the judgment of the treating physician.
- Adequate iron status defined as serum ferritin > 20 ng/ml and transferrin saturation of > 30% within 90 days prior to randomization.
- Symptoms attributed to the anemia with hemoglobin < 11 g/dL.
- Folate and Vitamin B12 levels within normal limits within 90 days prior to randomization.
Hepatic:
- SGOT (ALT) level < 2 x ULN within 14 days prior to randomization.
- SGPT (AST) level < 2 x ULN within 14 days prior to randomization.
- Serum total bilirubin level < 2 x ULN within 14 days prior to randomization.
Renal:
- Serum creatine < 1.5 x the upper limit of normal (ULN) within 14 days prior to randomization.
Cardiovascular:
- No uncontrolled hypertension (defined as a systolic pressure > 160 mmHg and/or a diastolic pressure > 110 mmHg).
- No history of (within 12 months) deep venous thrombosis (DVT), pulmonary embolism (PE), or other venous thrombosis. Prior superficial thrombophlebitis is not an exclusion criterion.
- No history of (within 6 months) cerebrovascular accident ([CVA] includes ischemic, embolic, and hemorrhagic), transient ischemic attack (TIA), myocardial ischemia (includes Unstable Angina, Q wave Myocardial Infarction [QwMI], and non-Q wave Myocardial Infarction [NQMI]), or other arterial thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Arm A | Experimental | Drug: Azacitidine, Drug: ErythropoietinAzacitidine + Erythropoietin |
| Investigational Arm B | Experimental | Drug: Azacitidine (Monotherapy)Azacitidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- A bone marrow (BM) aspirate and biopsy that demonstrates MDS with less than 11% blasts.
- Conventional metaphase cytogenetics done within 90 days prior to registration for screening.
- Central pathology review, correlative submission and confirmation of diagnosis is required prior to initiation of therapy (see Study Procedure Manual for details of submission). The FAB and WHO classification of MDS and the IPSS score will be determined at time of central pathology review.
- Correlative marrow aspirate obtained.
- To be eligible for randomization, subjects must have documentation of at least 1 of the following:
Key exclusion criteria (11 listed)
- No known history of intolerance to erythropoietic agents.
- No prior intensive cytotoxic chemotherapy for a myeloid malignancy including MDS.
- Patients with a history of a non-myeloid malignancy with secondary MDS are eligible for study enrollment provided, in the opinion of the treating investigator and the study chair, the anticipated behavior of the non-myeloid malignancy will not interfere with study participation and evaluation of outcome.
- No known or suspected hypersensitivity to azacitidine or mannitol.
- No hepatic tumors.
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 |
|---|---|---|
| AzacitidineAlso: VidazaAzacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks. | Drug | Investigational Arm A |
| ErythropoietinAlso: EPOErythropoietin 60,000IU subcutaneous injection weekly while on protocol therapy | Drug | Investigational Arm A |
| Azacitidine (Monotherapy)Also: VidazaAzacitidine 50 mg/m2 subcutaneously qod for two consecutive weeks every four weeks. | Drug | Investigational Arm B |
Primary outcome
Overall Response After Cycle 3
Time frame: 3 months
Overall response for participants who have completed at least three cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence. Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements.
Overall Response Rate After Six Cycles
Time frame: 6 months
Overall response rate for participants who have completed at least six cycles of protocol-specified therapy according to the International Working Group to Standardize Response Criteria for Myelodysplastic Syndromes criteria for Erythroid Response (HI-E) Major response: For patients with pretreatment hemoglobin less than 11 g/dL, greater than 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, transfusion independence. Minor response: For patients with pretreatment hemoglobin less than 11 g/dL, 1 to 2 g/dL increase in hemoglobin; for RBC transfusion-dependent patients, 50% decrease in transfusion requirements.
6 secondary outcomes
Safety Profile of the Modified Dose/Schedule of Azacitidine and Erythropoietin or a Modified Dose of Azacitidine Alone
Time frame: 24 months
Duration of Significant Responses
Time frame: 24 months
Quality of Life
Time frame: 24 months
Analysis of CD34, CD71, CD36 Cells in Aspirated Bone Marrow for Both Responders and Non-responders at Baseline and After Three and Six Cycles
Time frame: 6 months
Percent Apoptosis in 34+36+71+ Cells at Baseline, Three Cycles and Six Cycles
Time frame: Six months
BclXL Expression
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21420732Sayar H, Chan RJ, Orschell CM, Chan EM, Yu Z, Hood D, Plett A, Yang Z, Hui CL, Nabinger SC, Kohlbacher KJ, West ES, Walter A, Sampson C, Wu J, Cripe LD. Thrice weekly azacitidine does not improve hematological responses in lower-risk myelodysplastic syndromes: a study of the Hoosier Oncology Group. Leuk Res. 2011 Aug;35(8):1108-10. doi: 10.1016/j.leukres.2011.02.025. Epub 2011 Mar 21.
- Hoosier Oncology Group Home PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Larry Cripe, M.D. study chair
Hoosier Oncology Group, LLC
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine, Erythropoietin and Azacitidine (Monotherapy) in people with Myelodysplastic Syndromes, run by Larry Cripe, MD at 9 sites 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 14 inclusion and 11 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 31 May 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?
Overall Response After Cycle 3 (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT00379912, 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 14 Feb 2018.