Acute Myeloid LeukemiaPhase 4NCT01347996
Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia
A Phase 4 study testing histamine dihydrochloride and IL-2 in people with Acute Myeloid Leukemia, run by Cytovia, Inc. at 1 site in Sweden.
Trial summary
Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- histamine dihydrochloride and IL-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2009to Jun 2014
- Phase
- Phase 4
- 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
- AML patients in CR1 whose AML subtype has been well-characterized using conventional karyotyping and molecular genetic techniques (eg, RQ-PCR) at diagnosis. Patients may be considered eligible if they have not had this assessment performed at diagnosis provided that stored samples of diagnostic genetic material (DNA/RNA) from blood and BM are available that can be assayed for the presence of markers such as WT1 and/or AML-specific genetic markers.
- Bone marrow examination confirming CR (defined as less than 5% blasts in a normocellular bone marrow).
- Eighteen years of age or older.
- Patients have received any form of induction and consolidation therapy as per standard practice at the institution, including autologous stem cell transplantation (ASCT).
- Within 8 weeks following the date of the last dose of consolidation or conditioning chemotherapy for AML, or following ASCT.
- Patients not undergoing consolidation therapy must have been in CR1 for at least one month prior to enrollment.
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- Platelet count recovered after chemotherapy to ≥75 x 109/L, and Partial Thromboplastin Time (PTT) within normal limits.
- WBC ≥1.5 x 109/L and LFTs (to include SGPT [ALAT] or SGOT [AST] and bilirubin) should not exceed twice the upper limit of normal.
- Serum creatinine less than or equal to 1.5 times the upper normal limit.
- Able to function without significant decrease in daily activities (WHO Performance Status 0 - 1 or Karnofsky ≥70).
- Life expectancy of more than three months and able to undergo routine outpatient evaluations for efficacy, safety, and/or compliance.
- Women of childbearing potential must be practicing barrier or oral contraception, for the duration of the treatment, or documented as surgically sterile or one year post-menopausal.
- If female, be non-nursing, non-pregnant and have a negative pregnancy test within two weeks of starting study drug.
- The patient must be informed of the investigational nature of the study and written informed consent obtained.
Who cannot join
- Patients who have undergone or are planned for allogeneic stem cell transplantation.
- Patients with M3 as an AML subtype.
- Class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 12 months, active uncontrolled angina pectoris or symptomatic arteriosclerotic blood vessel disease.
- Other active malignancies except in situ carcinoma of the cervix, localized squamous or basal cell carcinoma of the skin.
- Serious concurrent or recent non-malignant medical conditions which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study.
- History of seizures, central nervous system disorders, stroke within the last 12 months, or psychiatric disability thought to be clinically significant in the opinion of the Investigator and adversely affecting compliance to protocol.
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- Patients unable to undergo repeat treatments, clinical evaluations and other diagnostic procedures required by the protocol.
- Active autoimmune disease (including but not limited to systemic lupus, inflammatory bowel disease, and psoriasis).
- Patients with active peptic or esophageal ulcer disease or with past peptic ulcer or esophageal disease with a history or bleeding.
- Patients requiring active treatment for hypotension.
- Medical, sociologic, or psychological impediment to probable compliance with the protocol.
- Patients continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents.
- Patients with a history of histamine hypersensitivity, severe allergies to food or contrast media requiring treatment within the last five years.
- Patients unable to provide written consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Multicenter, Effects of Remission Maintenance Therapy With Ceplene® , Given in Conjunction With Low-Dose Interleukin-2, on Immune Response and Minimal Residual Disease in Adult Patients With AML in First Complete Remission
Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. This is an international, multicenter, open-label study to evaluate the effects of remission maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune system cells (T and NK cells) and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML.
Read the detailed description
Outcome Measures:
Primary:
- To assess the quantitative and qualitative pharmacodynamic effects of Ceplene plus low-dose IL-2 (Ceplene/IL-2) by monitoring T and natural killer (NK) cell phenotypes and their functionality after the first and third treatment cycles in adult patients with acute myeloid leukemia (AML) in first complete remission (CR1).
- To evaluate minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2.
Secondary:
To document, in adult AML patients in CR1 treated with Ceplene/IL-2:
- Leukemia-free survival (LFS) after a follow-up period of up to two years.
- The safety of Ceplene/IL-2 therapy.
- The potential relationship of Ceplene/IL-2 effects on T and NK cell phenotypes and their functionality to MRD.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- histamine dihydrochloride and IL-2
- Keywords
- AML, Leukemia, Acute Myeloid Leukemia, Minimal Residual Disease, Ceplene, Histamine, interleukin 2
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
histamine dihydrochloride and IL-2Drug
Also called Ceplene, Proleukin, IL-2, interleukin-2
Ceplene 0.5 mg subcutaneously twice daily and IL-2 1 µg/kg [16,400 IU/kg] body weight twice daily for 10, 21 day cycles
| Study group | Role | What they receive |
|---|---|---|
| histamine dihydrochloride and IL-2 | Experimental | histamine and IL-2 subcutaneous injections Receives: Drug: histamine dihydrochloride and IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2
A second primary objective of this study is to evaluate MRD in patients who are receiving remission maintenance therapy with Ceplene/IL-2. MRD will be evaluated using RQ-PCR for molecular detection of genetic markers of AML. Patients' MRD status will be quantified at the time of enrollment (baseline) and within ten days after completion of Cycles 3, 5, 6, 7, 9 and 10 of Ceplene/IL-2 therapy, corresponding to approximately every 3 months during this immunotherapy.
Measured: Comparison at baseline and various time points up to 2 years
Pharmacodynamic effects of Ceplene plus low dose IL-2 (Ceplene/IL-2) by monitoring T and NK cell phenotypes and their functionality after the first and third cycles of treatment
The quantitative and qualitative pharmacodynamic effects of Ceplene/IL-2 on the immune responses of T and NK cells will be assessed as follows:
- Changes in T and NK cell phenotypes (CD56, CD3, CD4, CD8) in peripheral blood from Day 1 (baseline) to Day 21‡ of Cycle 1 and from Day 1 (pre-treatment Cycle 3) to Day 21‡ of Cycle 3.
- Changes in immune response markers (CD3, NKp46 [and other NCRs], CD25, CD69, and IFN-γ) in peripheral blood from Day 1 (baseline) to Day 21‡ of Cycle 1 and from Day 1 (pre-treatment Cycle 3) to Day 21‡ of Cycle 3
Measured: Baseline vs Cycle 1 and 3
Secondary outcomes (1)
Duration of LFS
Duration of LFS: LFS will be defined as the time from achieving CR after successful induction therapy until relapse of AML (defined as 5% or more blast cells in the bone marrow).
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startJul 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytovia, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- EpiCept Corporation
- Responsible party
- Sponsor
- Investigators
- Robin FOA, MD, PhD, Study chair, Università degli Studi di Roma "La Sapienza" Dipartimento di Biotecnologie Cellulari ed EmatolgiaMats L Brune, MD, PhD, Principal investigator, Sahlgrenska Academy University of Gothenburg, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347996
- Sponsor's protocol ID
- EPC2008-02
- Status last verified
- Nov 2017
- First submitted
- 2 May 2011
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hussein BA, Hallner A, Wennstrom L, Brune M, Martner A, Hellstrand K, Bernson E, Thoren FB. Impact of NK Cell Activating Receptor Gene Variants on Receptor Expression and Outcome of Immunotherapy in Acute Myeloid Leukemia. Front Immunol. 2021 Dec 9;12:796072. doi: 10.3389/fimmu.2021.796072. eCollection 2021.
PubMed 34956230Grauers Wiktorin H, Aydin E, Christenson K, Issdisai N, Thoren FB, Hellstrand K, Martner A. Impact of IL-1beta and the IL-1R antagonist on relapse risk and survival in AML patients undergoing immunotherapy for remission maintenance. Oncoimmunology. 2021 Jul 25;10(1):1944538. doi: 10.1080/2162402X.2021.1944538. eCollection 2021.
PubMed 34367728Grauers Wiktorin H, Nilsson MS, Kiffin R, Sander FE, Lenox B, Rydstrom A, Hellstrand K, Martner A. Histamine targets myeloid-derived suppressor cells and improves the anti-tumor efficacy of PD-1/PD-L1 checkpoint blockade. Cancer Immunol Immunother. 2019 Feb;68(2):163-174. doi: 10.1007/s00262-018-2253-6. Epub 2018 Oct 12.
PubMed 30315349Sander FE, Nilsson M, Rydstrom A, Aurelius J, Riise RE, Movitz C, Bernson E, Kiffin R, Stahlberg A, Brune M, Foa R, Hellstrand K, Thoren FB, Martner A. Role of regulatory T cells in acute myeloid leukemia patients undergoing relapse-preventive immunotherapy. Cancer Immunol Immunother. 2017 Nov;66(11):1473-1484. doi: 10.1007/s00262-017-2040-9. Epub 2017 Jul 18.
PubMed 28721449Bernson E, Hallner A, Sander FE, Wilsson O, Werlenius O, Rydstrom A, Kiffin R, Brune M, Foa R, Aurelius J, Martner A, Hellstrand K, Thoren FB. Impact of killer-immunoglobulin-like receptor and human leukocyte antigen genotypes on the efficacy of immunotherapy in acute myeloid leukemia. Leukemia. 2017 Dec;31(12):2552-2559. doi: 10.1038/leu.2017.151. Epub 2017 May 22.
PubMed 28529313Rydstrom A, Hallner A, Aurelius J, Sander FE, Bernson E, Kiffin R, Thoren FB, Hellstrand K, Martner A. Dynamics of myeloid cell populations during relapse-preventive immunotherapy in acute myeloid leukemia. J Leukoc Biol. 2017 Aug;102(2):467-474. doi: 10.1189/jlb.5VMA1116-455R. Epub 2017 Feb 24.
PubMed 28235771Sander FE, Rydstrom A, Bernson E, Kiffin R, Riise R, Aurelius J, Anderson H, Brune M, Foa R, Hellstrand K, Thoren FB, Martner A. Dynamics of cytotoxic T cell subsets during immunotherapy predicts outcome in acute myeloid leukemia. Oncotarget. 2016 Feb 16;7(7):7586-96. doi: 10.18632/oncotarget.7210.
PubMed 26863635
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multicenter, Effects of Remission Maintenance Therapy With Ceplene® , Given in Conjunction With Low-Dose Interleukin-2, on Immune Response and Minimal Residual Disease in Adult Patients With AML in First Complete Remission
- ClinicalTrials.gov ID
- NCT01347996
- Acronym / sponsor ID
- EPC2008-02
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, Leukemia, Acute Myeloid Leukemia, Minimal Residual Disease, Ceplene, Histamine, interleukin 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cytovia, Inc.University, hospital or other
- Collaborators
- EpiCept Corporation
- Study start
- Jul 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 May 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.
Ceplene/IL-2 remission maintenance therapy has been shown to significantly prolong Leukemia Free Survival in patients with Acute Myeloid Leukemia (AML) in first complete remission. This is an international, multicenter, open-label study to evaluate the effects of remission maintenance therapy with Ceplene/IL-2 in adult patients with AML in CR1 on specific immune system cells (T and NK cells) and prospectively defined markers of immune response that are known to reflect T and NK cell ability to combat AML.
Detailed description
Outcome Measures:
Primary:
- To assess the quantitative and qualitative pharmacodynamic effects of Ceplene plus low-dose IL-2 (Ceplene/IL-2) by monitoring T and natural killer (NK) cell phenotypes and their functionality after the first and third treatment cycles in adult patients with acute myeloid leukemia (AML) in first complete remission (CR1).
- To evaluate minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2.
Secondary:
To document, in adult AML patients in CR1 treated with Ceplene/IL-2:
- Leukemia-free survival (LFS) after a follow-up period of up to two years.
- The safety of Ceplene/IL-2 therapy.
- The potential relationship of Ceplene/IL-2 effects on T and NK cell phenotypes and their functionality to MRD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| histamine dihydrochloride and IL-2 | Experimental | Drug: histamine dihydrochloride and IL-2histamine and IL-2 subcutaneous injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- AML patients in CR1 whose AML subtype has been well-characterized using conventional karyotyping and molecular genetic techniques (eg, RQ-PCR) at diagnosis. Patients may be considered eligible if they have not had this assessment performed at diagnosis provided that stored samples of diagnostic genetic material (DNA/RNA) from blood and BM are available that can be assayed for the presence of markers such as WT1 and/or AML-specific genetic markers.
- Bone marrow examination confirming CR (defined as less than 5% blasts in a normocellular bone marrow).
- Eighteen years of age or older.
- Patients have received any form of induction and consolidation therapy as per standard practice at the institution, including autologous stem cell transplantation (ASCT).
- Within 8 weeks following the date of the last dose of consolidation or conditioning chemotherapy for AML, or following ASCT.
Key exclusion criteria (14 listed)
- Patients who have undergone or are planned for allogeneic stem cell transplantation.
- Patients with M3 as an AML subtype.
- Class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 12 months, active uncontrolled angina pectoris or symptomatic arteriosclerotic blood vessel disease.
- Other active malignancies except in situ carcinoma of the cervix, localized squamous or basal cell carcinoma of the skin.
- Serious concurrent or recent non-malignant medical conditions which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| histamine dihydrochloride and IL-2Also: Ceplene, Proleukin, IL-2, interleukin-2Ceplene 0.5 mg subcutaneously twice daily and IL-2 1 µg/kg [16,400 IU/kg] body weight twice daily for 10, 21 day cycles | Drug | histamine dihydrochloride and IL-2 |
Primary outcome
Minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2
Time frame: Comparison at baseline and various time points up to 2 years
A second primary objective of this study is to evaluate MRD in patients who are receiving remission maintenance therapy with Ceplene/IL-2. MRD will be evaluated using RQ-PCR for molecular detection of genetic markers of AML. Patients' MRD status will be quantified at the time of enrollment (baseline) and within ten days after completion of Cycles 3, 5, 6, 7, 9 and 10 of Ceplene/IL-2 therapy, corresponding to approximately every 3 months during this immunotherapy.
Pharmacodynamic effects of Ceplene plus low dose IL-2 (Ceplene/IL-2) by monitoring T and NK cell phenotypes and their functionality after the first and third cycles of treatment
Time frame: Baseline vs Cycle 1 and 3
The quantitative and qualitative pharmacodynamic effects of Ceplene/IL-2 on the immune responses of T and NK cells will be assessed as follows: 1. Changes in T and NK cell phenotypes (CD56, CD3, CD4, CD8) in peripheral blood from Day 1 (baseline) to Day 21‡ of Cycle 1 and from Day 1 (pre-treatment Cycle 3) to Day 21‡ of Cycle 3. 2. Changes in immune response markers (CD3, NKp46 [and other NCRs], CD25, CD69, and IFN-γ) in peripheral blood from Day 1 (baseline) to Day 21‡ of Cycle 1 and from Day 1 (pre-treatment Cycle 3) to Day 21‡ of Cycle 3
1 secondary outcome
Duration of LFS
Time frame: up to 2 years
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 29 Nov 2017.
- Derived from this study: PubMed 34956230Hussein BA, Hallner A, Wennstrom L, Brune M, Martner A, Hellstrand K, Bernson E, Thoren FB. Impact of NK Cell Activating Receptor Gene Variants on Receptor Expression and Outcome of Immunotherapy in Acute Myeloid Leukemia. Front Immunol. 2021 Dec 9;12:796072. doi: 10.3389/fimmu.2021.796072. eCollection 2021.
- Derived from this study: PubMed 34367728Grauers Wiktorin H, Aydin E, Christenson K, Issdisai N, Thoren FB, Hellstrand K, Martner A. Impact of IL-1beta and the IL-1R antagonist on relapse risk and survival in AML patients undergoing immunotherapy for remission maintenance. Oncoimmunology. 2021 Jul 25;10(1):1944538. doi: 10.1080/2162402X.2021.1944538. eCollection 2021.
- Derived from this study: PubMed 30315349Grauers Wiktorin H, Nilsson MS, Kiffin R, Sander FE, Lenox B, Rydstrom A, Hellstrand K, Martner A. Histamine targets myeloid-derived suppressor cells and improves the anti-tumor efficacy of PD-1/PD-L1 checkpoint blockade. Cancer Immunol Immunother. 2019 Feb;68(2):163-174. doi: 10.1007/s00262-018-2253-6. Epub 2018 Oct 12.
- Derived from this study: PubMed 28721449Sander FE, Nilsson M, Rydstrom A, Aurelius J, Riise RE, Movitz C, Bernson E, Kiffin R, Stahlberg A, Brune M, Foa R, Hellstrand K, Thoren FB, Martner A. Role of regulatory T cells in acute myeloid leukemia patients undergoing relapse-preventive immunotherapy. Cancer Immunol Immunother. 2017 Nov;66(11):1473-1484. doi: 10.1007/s00262-017-2040-9. Epub 2017 Jul 18.
- Derived from this study: PubMed 28529313Bernson E, Hallner A, Sander FE, Wilsson O, Werlenius O, Rydstrom A, Kiffin R, Brune M, Foa R, Aurelius J, Martner A, Hellstrand K, Thoren FB. Impact of killer-immunoglobulin-like receptor and human leukocyte antigen genotypes on the efficacy of immunotherapy in acute myeloid leukemia. Leukemia. 2017 Dec;31(12):2552-2559. doi: 10.1038/leu.2017.151. Epub 2017 May 22.
- Derived from this study: PubMed 28235771Rydstrom A, Hallner A, Aurelius J, Sander FE, Bernson E, Kiffin R, Thoren FB, Hellstrand K, Martner A. Dynamics of myeloid cell populations during relapse-preventive immunotherapy in acute myeloid leukemia. J Leukoc Biol. 2017 Aug;102(2):467-474. doi: 10.1189/jlb.5VMA1116-455R. Epub 2017 Feb 24.
- Derived from this study: PubMed 26863635Sander FE, Rydstrom A, Bernson E, Kiffin R, Riise R, Aurelius J, Anderson H, Brune M, Foa R, Hellstrand K, Thoren FB, Martner A. Dynamics of cytotoxic T cell subsets during immunotherapy predicts outcome in acute myeloid leukemia. Oncotarget. 2016 Feb 16;7(7):7586-96. doi: 10.18632/oncotarget.7210.
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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.
Robin FOA, MD, PhD study chair
Università degli Studi di Roma "La Sapienza" Dipartimento di Biotecnologie Cellulari ed Ematolgia
Mats L Brune, MD, PhD principal investigator
Sahlgrenska Academy University of Gothenburg, Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing histamine dihydrochloride and IL-2 in people with Acute Myeloid Leukemia, run by Cytovia, Inc. at 1 site in Sweden.
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 14 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 29 Nov 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 Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2 (time frame: Comparison at baseline and various time points up to 2 years). 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 NCT01347996, which also lists 7 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 29 Nov 2017.