Polycythemia VeraPhase 3DALIAHNCT01387763
A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms
A Phase 3 study testing PegIntron, Pegasys and Hydrea in people with Polycythemia Vera and Essential Thrombocythemia, run by Thomas Stauffer Larsen at 8 sites in Denmark.
Trial summary
The purpose of the study is to compare the efficacy and toxicity including quality of life of two types of low-dose interferon alpha compounds (PegIntron and Pegasys) with hydroxyurea (Hydrea), and to investigate the occurence of neutralizing antibodies against recombinant interferon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera, Essential Thrombocythemia, Primary Myelofibrosis
- What is being tested?
- PegIntron, Pegasys and Hydrea
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 8 sitesDenmark
- Study dates
- Jan 2012to Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female > 18 years of age
- Newly diagnosed, or previously diagnosed untreated patients with ET, PV or PMF including prefibrotic myelofibrosis according to the WHO classification
- Active disease defined by one of the following criteria:
- need for phlebotomy
- leukocytosis > 10 mia/l
- thrombocytosis > 400 mia/l
Show all 10Show fewer
- constitutional symptoms (fatigue, weight loss, night sweats or fewer > 38 degrees celsius)
- Pruritus
- splenomegaly causing symptoms
- previous thrombosis
Who cannot join
- Fertile women without a negative pregnancy test
- Other malignant disease within last 5 years
- ECOG performance score >/= 3
- Creatinine > 2x ULN
- Bilirubin > 1.5x ULN
- ALAT > 3x ULN
Show all 9Show fewer
- Previous psychiatric disorder (depression)
- active autoimmune disease
- Uncontrolled thyroid disease
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Dept of Hematology, Aalborg hospital
Aalborg, 9000
Dept. of Hematology, Aarhus University Hospital
Aarhus, 8000
Dept of Hematology, Rigshospitalet
Copenhagen, 2100
Dept of Hematology, Esbjerg Hospital
Esbjerg, 6700
Dept of Hematology, Herlev Hospital
Herlev, 2730
Dept of Hematology, Holstebro Hospital
Holstebro, 7500
Dept of hematology, Odense University Hospital
Odense, 5000
Dept. of Hematology, Roskilde Hospital
Roskilde, 4000
About this study
Official title: Danish Study of Low-dose Interferon Alpha Versus Hydroxyurea in the Treatment of Philadelphia Chromosome Negative (Ph-)Chronic Myeloid Neoplasms.
The purpose of the study is to compare the efficacy and toxicity including quality of life of two types of low-dose interferon alpha compounds (PegIntron and Pegasys) with hydroxyurea (Hydrea), and to investigate the occurence of neutralizing antibodies against recombinant interferon.
Read the detailed description
Chronic myeloid neoplasms (CMPN) consists of three main entities, polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF). These three disorders have many overlapping clinical features. The diseases are clonal stem cell disorders characterized by a chronic excess production of mainly mature myeloid cells. The excess production of clonal red cells (in PV), platelets (in PV, ET and PMF) and leukocytes (mainly PV and PMF)leads to a highly increased risk of thrombosis. Patients may also suffer from constitutional symptoms, pruritus and splenomegaly. An inherent feature of these diseases are the risk of ET and PV of transformation to myelofibrosis and a risk of both ET, PV and PMF of leukemic transformation.
In 2005 major breakthrough in our understanding of the molecular pathophysiology was achieved with the identification of the JAK2 V617F mutation which is present in almost all patients with PV (98%) and about half of patients with ET and PMF. This somatic gain-of-function point mutation in the JAK2 tyrosine kinase leads to constitutive activation of the kinase. By this mechanism a clonal non-growth factor dependent myeloproliferation is established.
Traditionally the excess platelet and white cell production in ET, PV and PMF has been treated with cytoreductive agents such as hydroxyurea and busulfan in order to normalize the blood counts and thereby reducing the risk of thrombosis. However, in younger patients there is a concern of the leukemogenic potential of these agents. In younger patients an alternative treatment option is recombinant pegylated interferon alpha (IFN-alpha), which has demonstrated high clinical efficacy and has no leukemogenic potential. Within recent years IFN-alpha has demonstrated a capacity of inducing deep molecular remission (evaluated by JAK2 V617F qPCR) and normalisation of bone marrow morphology. These remissions have been sustained for up to 3 years after discontinuation of IFN-alpha therapy. Accordingly a perspective of changing the natural history of these disorders towards myelofibrosis and ultimately acute leukemia has emerged. However toxicity has been a major issue and drop-of rates have been reported consistently around 25 %.
It is well known from other diseases (e.g multiple sclerosis and hepatitis) that some patients develop neutralizing antibodies against IFN-alpha. This issue is however only scarcely investigated in CMPN and has never been tested in a prospective design.
The purpose of this study is to compare the efficacy (hematological and molecular) and toxicity profile of two different recombinant interferon alpha products, IFN-alpha2a and IFN-alpha2b in a prospective randomized design. In patients over the age of 60 there will be a third study arm with hydroxyurea.
In order to decrease drop out rates and thereby increasing response rates patients will be started of at a low-dose of IFN-alpha. If patients fail to respond or looses their response and develops neutralizing antibodies against IFN-alpha therapy will be stopped. If patients have a sustained deep molecular response (below 1 % JAK2 V617F mutated alleles for 12 months) therapy will be stopped to asses the sustainability of the remission off therapy.Patients over the age of 75 and intolerant or resistant to hydroxyurea will be offered rescue treatment with orally busulfan (Myleran). As an important part of the study quality of life will be investigated.
- Being tested
- PegIntron, Pegasys, Hydrea
- Medical subject headings
- Polycythemia Vera, Thrombocythemia, Essential, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegIntronDrug
Also called Pegylated interferon alpha 2b
PegIntron, prefilled syringe 50 micrograms/0.5 ml. 30 micrograms subcutaneously once weekly.
PegasysDrug
Also called Pegylated interferon alpha 2a
Pegasys, prefilled syringe 180 micrograms/0.5 ml 45 micrograms subcutaneously once weekly
PegIntronDrug
Also called Pegylated interferon alpha 2b
PegIntron, prefilled syringe 50 micrograms/0.5 ml. 30 micrograms subcutaneously once weekly.
PegasysDrug
Also called Pegylated interferon alpha 2a
Pegasys, prefilled syringe 180 micrograms/0.5 ml 45 micrograms subcutaneously once weekly
HydreaDrug
Also called hydroxyurea, hydroxycarbamide
Capsule Hydrea 500-2000 mg orally QD or BID
| Study group | Role | What they receive |
|---|---|---|
| PegIntron <= 60 years | Active comparator | In patients <= 60 years PegIntron is started at low-dose 35 micrograms once weekly. Dose escalation to 50 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 50 micrograms weekly at 12 months and 18 months respectively, dose escalation to 96 micrograms weekly. Receives: Drug: PegIntron |
| Pegasys <= 60 years | Active comparator | In patients <= 60 years Pegasys is started at low-dose 45 micrograms once weekly. Dose escalation to 90 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 90 micrograms weekly at 12 months and 18 months respectively, dose escalation to 135 micrograms weekly. Receives: Drug: Pegasys |
| PegIntron > 60 years | Active comparator | In patients < 60 years PegIntron is started at low-dose 35 micrograms once weekly. Dose escalation to 50 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 50 micrograms weekly at 12 months and 18 months respectively, dose escalation to 96 micrograms weekly. Receives: Drug: PegIntron |
| Pegasys > 60 years | Active comparator | In patients > 60 years Pegasys is started at low-dose 45 micrograms once weekly. Dose escalation to 90 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 90 micrograms weekly at 12 months and 18 months respectively, dose escalation to 135 micrograms weekly. Receives: Drug: Pegasys |
| Hydroxyurea > 60 years | Active comparator | Capsule Hydrea 500-2000 mg orally QD or BID Receives: Drug: Hydrea |
What is being measured
The primary outcome is the main question the study is designed to answer.
molecular response (changes from baseline)
Molecular responses (JAK V617F allele burden) are assessed by qPCR according to the ELN guidelines.
Measured: 18, 36 and 60 months
Secondary outcomes (6)
toxicity (discontinuation of therapy due to intolerability)
The proportion of patients treated with PegIntron, Pegasys and Hydrea who need to discontinue therapy due to intolerability
Measured: 18 months
Quality of life (changes from baseline)
Quality of life will be evaluated according to EORTC QLQ C-30 and MPN-SAF
Measured: 4, 12, 24, 36, 48 and 60 months
Histopathological response (changes from baseline)
A bone marrow sample will be evaluated in order to detect and grade changes in bone marrow morphology.
Measured: 36 and 60 months
Sustained molecular response (changes from level at time of discontinuation of therapy)
investigation of the sustainability of an obtained molecular remission (<
1% JAK2V617F mutated alleles) after discontinuation of interferon- alpha( Pegasys, PegIntron, Multiferon) or Hydrea.
Measured: 12, 24 and 36 months
Neutralizing antibodies against PegIntron and Pegasys
Proportion of patients treated with Peintron and Pegasys who have developed neutralizing antibodies.
Measured: 24 months
hematological response
Hematological response will be evaluated according to the ELN guidelines.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2020
- Study completionJun 2020
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 Polycythemia VeraStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Stauffer Larsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Stauffer Larsen, Odense University Hospital
- Investigators
- Thomas S Larsen, MD PhD, Principal investigator, Dept. of Hematology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387763
- Sponsor's protocol ID
- daliah2011
- Acronym
- DALIAH
- Status last verified
- Apr 2022
- First submitted
- 23 Jun 2011
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Knudsen TA, Hansen DL, Ocias LF, Bjerrum OW, Brabrand M, Christensen SF, Eickhardt-Dalboge CS, Ellervik C, El Fassi D, Frederiksen M, Kjaer L, Kristensen TK, Kruse TA, Larsen MK, Mourits-Andersen T, Moller S, Overgaard UM, Severinsen MT, Skov V, Sorensen AL, Stentoft J, Starklint J, de Stricker K, Thomassen M, Larsen TS, Hasselbalch HC. Interferon-alpha vs hydroxyurea in patients with myeloproliferative neoplasms (DALIAH): a multicentre, randomised, open-label, phase 3 trial in Denmark. EClinicalMedicine. 2026 Sep 9;100:104193. doi: 10.1016/j.eclinm.2026.104193. eCollection 2026 Oct.
PubMed 42751490Bistrup CN, Larsen MK, Junker P, Skov V, Kjaer L, Knudsen TA, Karsdal M, Willumsen N, Hasselbalch HC. Collagen Turnover Is Associated with Disease Severity, Bone Marrow Fibrosis, and the JAK2V617F Variant Allele Frequency in Myeloproliferative Neoplasms. Cancers (Basel). 2026 Aug 6;18(15):2529. doi: 10.3390/cancers18152529.
PubMed 42588744
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Study of Low-dose Interferon Alpha Versus Hydroxyurea in the Treatment of Philadelphia Chromosome Negative (Ph-)Chronic Myeloid Neoplasms.
- ClinicalTrials.gov ID
- NCT01387763
- Acronym / sponsor ID
- DALIAH / daliah2011
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Thomas Stauffer LarsenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 6 Jul 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 purpose of the study is to compare the efficacy and toxicity including quality of life of two types of low-dose interferon alpha compounds (PegIntron and Pegasys) with hydroxyurea (Hydrea), and to investigate the occurence of neutralizing antibodies against recombinant interferon.
Detailed description
Chronic myeloid neoplasms (CMPN) consists of three main entities, polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF). These three disorders have many overlapping clinical features. The diseases are clonal stem cell disorders characterized by a chronic excess production of mainly mature myeloid cells. The excess production of clonal red cells (in PV), platelets (in PV, ET and PMF) and leukocytes (mainly PV and PMF)leads to a highly increased risk of thrombosis. Patients may also suffer from constitutional symptoms, pruritus and splenomegaly. An inherent feature of these diseases are the risk of ET and PV of transformation to myelofibrosis and a risk of both ET, PV and PMF of leukemic transformation.
In 2005 major breakthrough in our understanding of the molecular pathophysiology was achieved with the identification of the JAK2 V617F mutation which is present in almost all patients with PV (98%) and about half of patients with ET and PMF. This somatic gain-of-function point mutation in the JAK2 tyrosine kinase leads to constitutive activation of the kinase. By this mechanism a clonal non-growth factor dependent myeloproliferation is established.
Traditionally the excess platelet and white cell production in ET, PV and PMF has been treated with cytoreductive agents such as hydroxyurea and busulfan in order to normalize the blood counts and thereby reducing the risk of thrombosis. However, in younger patients there is a concern of the leukemogenic potential of these agents. In younger patients an alternative treatment option is recombinant pegylated interferon alpha (IFN-alpha), which has demonstrated high clinical efficacy and has no leukemogenic potential. Within recent years IFN-alpha has demonstrated a capacity of inducing deep molecular remission (evaluated by JAK2 V617F qPCR) and normalisation of bone marrow morphology. These remissions have been sustained for up to 3 years after discontinuation of IFN-alpha therapy. Accordingly a perspective of changing the natural history of these disorders towards myelofibrosis and ultimately acute leukemia has emerged. However toxicity has been a major issue and drop-of rates have been reported consistently around 25 %.
It is well known from other diseases (e.g multiple sclerosis and hepatitis) that some patients develop neutralizing antibodies against IFN-alpha. This issue is however only scarcely investigated in CMPN and has never been tested in a prospective design.
The purpose of this study is to compare the efficacy (hematological and molecular) and toxicity profile of two different recombinant interferon alpha products, IFN-alpha2a and IFN-alpha2b in a prospective randomized design. In patients over the age of 60 there will be a third study arm with hydroxyurea.
In order to decrease drop out rates and thereby increasing response rates patients will be started of at a low-dose of IFN-alpha. If patients fail to respond or looses their response and develops neutralizing antibodies against IFN-alpha therapy will be stopped. If patients have a sustained deep molecular response (below 1 % JAK2 V617F mutated alleles for 12 months) therapy will be stopped to asses the sustainability of the remission off therapy.Patients over the age of 75 and intolerant or resistant to hydroxyurea will be offered rescue treatment with orally busulfan (Myleran). As an important part of the study quality of life will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PegIntron <= 60 years | Active comparator | Drug: PegIntronIn patients <= 60 years PegIntron is started at low-dose 35 micrograms once weekly. Dose escalation to 50 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 50 micrograms weekly at 12 months and 18 months respectively, dose escalation to 96 micrograms weekly. |
| Pegasys <= 60 years | Active comparator | Drug: PegasysIn patients <= 60 years Pegasys is started at low-dose 45 micrograms once weekly. Dose escalation to 90 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 90 micrograms weekly at 12 months and 18 months respectively, dose escalation to 135 micrograms weekly. |
| PegIntron > 60 years | Active comparator | Drug: PegIntronIn patients < 60 years PegIntron is started at low-dose 35 micrograms once weekly. Dose escalation to 50 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 50 micrograms weekly at 12 months and 18 months respectively, dose escalation to 96 micrograms weekly. |
| Pegasys > 60 years | Active comparator | Drug: PegasysIn patients > 60 years Pegasys is started at low-dose 45 micrograms once weekly. Dose escalation to 90 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 90 micrograms weekly at 12 months and 18 months respectively, dose escalation to 135 micrograms weekly. |
| Hydroxyurea > 60 years | Active comparator | Drug: HydreaCapsule Hydrea 500-2000 mg orally QD or BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female > 18 years of age
- Newly diagnosed, or previously diagnosed untreated patients with ET, PV or PMF including prefibrotic myelofibrosis according to the WHO classification
- Active disease defined by one of the following criteria:
- need for phlebotomy
- leukocytosis > 10 mia/l
Key exclusion criteria (9 listed)
- Fertile women without a negative pregnancy test
- Other malignant disease within last 5 years
- ECOG performance score >/= 3
- Creatinine > 2x ULN
- Bilirubin > 1.5x ULN
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 |
|---|---|---|
| PegIntronAlso: Pegylated interferon alpha 2bPegIntron, prefilled syringe 50 micrograms/0.5 ml. 30 micrograms subcutaneously once weekly. | Drug | PegIntron <= 60 years |
| PegasysAlso: Pegylated interferon alpha 2aPegasys, prefilled syringe 180 micrograms/0.5 ml 45 micrograms subcutaneously once weekly | Drug | Pegasys <= 60 years |
| PegIntronAlso: Pegylated interferon alpha 2bPegIntron, prefilled syringe 50 micrograms/0.5 ml. 30 micrograms subcutaneously once weekly. | Drug | PegIntron > 60 years |
| PegasysAlso: Pegylated interferon alpha 2aPegasys, prefilled syringe 180 micrograms/0.5 ml 45 micrograms subcutaneously once weekly | Drug | Pegasys > 60 years |
| HydreaAlso: hydroxyurea, hydroxycarbamideCapsule Hydrea 500-2000 mg orally QD or BID | Drug | Hydroxyurea > 60 years |
Primary outcome
molecular response (changes from baseline)
Time frame: 18, 36 and 60 months
Molecular responses (JAK V617F allele burden) are assessed by qPCR according to the ELN guidelines.
6 secondary outcomes
toxicity (discontinuation of therapy due to intolerability)
Time frame: 18 months
Quality of life (changes from baseline)
Time frame: 4, 12, 24, 36, 48 and 60 months
Histopathological response (changes from baseline)
Time frame: 36 and 60 months
Sustained molecular response (changes from level at time of discontinuation of therapy)
Time frame: 12, 24 and 36 months
Neutralizing antibodies against PegIntron and Pegasys
Time frame: 24 months
hematological response
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 42751490Knudsen TA, Hansen DL, Ocias LF, Bjerrum OW, Brabrand M, Christensen SF, Eickhardt-Dalboge CS, Ellervik C, El Fassi D, Frederiksen M, Kjaer L, Kristensen TK, Kruse TA, Larsen MK, Mourits-Andersen T, Moller S, Overgaard UM, Severinsen MT, Skov V, Sorensen AL, Stentoft J, Starklint J, de Stricker K, Thomassen M, Larsen TS, Hasselbalch HC. Interferon-alpha vs hydroxyurea in patients with myeloproliferative neoplasms (DALIAH): a multicentre, randomised, open-label, phase 3 trial in Denmark. EClinicalMedicine. 2026 Sep 9;100:104193. doi: 10.1016/j.eclinm.2026.104193. eCollection 2026 Oct.
- Derived from this study: PubMed 42588744Bistrup CN, Larsen MK, Junker P, Skov V, Kjaer L, Knudsen TA, Karsdal M, Willumsen N, Hasselbalch HC. Collagen Turnover Is Associated with Disease Severity, Bone Marrow Fibrosis, and the JAK2V617F Variant Allele Frequency in Myeloproliferative Neoplasms. Cancers (Basel). 2026 Aug 6;18(15):2529. doi: 10.3390/cancers18152529.
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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.
Thomas S Larsen, MD PhD principal investigator
Dept. of Hematology, Odense University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PegIntron, Pegasys and Hydrea in people with Polycythemia Vera and Essential Thrombocythemia, run by Thomas Stauffer Larsen at 8 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
molecular response (changes from baseline) (time frame: 18, 36 and 60 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 NCT01387763, 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 27 Apr 2022.