Myelodysplastic SyndromePhase 1PODACNCT01277484
Dose Finding Study of Post-BMT Decitabine Maintenance Treatment in Higher-risk MDS and MDS/AML
A Phase 1 study testing Decitabine in people with Myelodysplastic Syndrome and Acute Myeloid Leukemia, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
Brief Scientific Rationale: Decitabine has been shown to be effective for treatment of MDS and associated with very limited extramedullary toxicity at the lower doses. Furthermore, the hypomethylating effects of decitabine require an extended period of therapy and are likely to be more beneficial in the setting of a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- What is being tested?
- Decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Dec 2015
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of MDS (IPSS intermediate-2 or higher) before allogeneic transplantation
- HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with 2 allele mismatch)
- Performance status < ECOG 2
- Acceptable organ function defined as:Serum creatinine < 1.5 times the institutional ULN,Serum bilirubin < 1.5 times the institutional ULN,AST, ALT and alkaline phosphatase < 3 times the institutional ULN.
- 6 to 10 weeks after alloHSCT
- patients who are confirmed complete remission(CR) within 2 weeks for treatment start(CR:less than 5% blasts in an aspirate bone marrow sample or no leukemic blasts in the peripheral blood, no cytogenetic aberrations)
Show all 10Show fewer
- Performance status < ECOG 2
- Acceptable organ function defined as:Serum creatinine < 1.5 times the institutional ULN,Serum bilirubin < 1.5 times the institutional ULN,AST, ALT and alkaline phosphatase < 3 times the institutional ULN.
- Platelet count ≥ 30,000/μL without platelet transfusion for 7 days and ANC ≥ 1,000/μL without colony stimulating factor support at the time of enrollment
- Written informed consent form
Who cannot join
- HIV positive
- Active uncontrolled infection
- Pregnancy or breastfeeding
- patients who have residual disease after allo SCT or primary graft failure
- Uncontrolled grade 3- 4 acute GVHD
- patients who are known or suspected hypersensitivity to decitabine
- patient who are not suitable for the trial in accordance with principal investigator's decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Arm, Open Label, Phase I Study for Dose and Schedule Finding of Decitabine in Patients With Higher-risk MDS and MDS/AML Receiving Allogeneic Stem Cell Transplantation
Brief Scientific Rationale:
Decitabine has been shown to be effective for treatment of MDS and associated with very limited extramedullary toxicity at the lower doses. Furthermore, the hypomethylating effects of decitabine require an extended period of therapy and are likely to be more beneficial in the setting of a minimal residual disease after transplantation. The drug might exert a cytoreductive effect on the MDS clone, but ex vivo expansion strategy using decitabine and HDAC inhibitor provides a potential to expand the number of hematopoietic stem cells. There are lots of evidence which showed the the drug have immunostimulatory effects and can be used to enhance graft-versus leukemia effects. And also, some investigator suggested that decitabine could induce FOXP3 expression, promoting the conversion of naïve T cells to Tregs which are known to suppress GVHD while maintaining GVL effect in allo-SCT setting. As such, decitabine is an ideal agent to be investigated in the post-transplant setting.
The investigators hypothesized that post-transplant maintenance therapy with decitabine may reduce relapse rate, which may maximize the beneficial effects from reduced TRM of ATG-containing FB4 or FB2 conditioning regimen in higher-risk MDS or AML evolving from MDS patients.
Read the detailed description
- Transplant course
- BMT from an HLA-matched sibling or a suitably matched (up to 2-allele mismatched) family or unrelated donor will be performed according to the policies of the institute.
- A preparative regimen will be started 6 days before the day of stem cell infusion
- Myeloablative-intensity conditioning regimen: FB4+ATG
- Reduced-intensity conditioning regimen; FB2+ATG
- Graft-versus-host disease prophylaxis
- Sibling transplant: Cyclosporine and short-course Methotrexate
- Unrelated transplant: Tacrolimus and short-course Methotrexate
- The dose of calcineurin inhibitors (cyclosporine and tacrolimus) will be gradually tapered from day 60 (for all sibling transplants) or day 90 (for all unrelated transplants) and discontinued within 2 or 3 months after SCT in the absence of graft-versus-host disease.
- Decitabine maintenance course
- For the patients who finish the above transplant procedure and meet the enrollment criteria, decitabine will be given at a dose of 5mg/m2/day ~ 15mg/m2/day iv over 1 hour for 5 consecutive days. The drug will be repeated every 4 weeks for up to 12 cycles.
- Dose escalation strategy between cohorts and between cycles in the same cohort patients will be based upon the quantitatively measured hematological toxicity (e.g., ANC or platelet count at nadir). In other words, a mechanism-based pharmacokinetic / pharmacodynamic model developed using sparsely sampled patients' PK data and toxicity response will be used to titrate next cycle doses for the patients and initial doses for new cohort patients. In other words, a mechanism-based pharmacokinetic / pharmacodynamic model developed using sparsely sampled patients' PK data and toxicity response will be used to titrate next cycle doses for the patients and initial doses for new cohort patients.
- Conditions
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- Being tested
- Decitabine
- Keywords
- decitabine, dose, schedule, safety, allogeneic stem cell transplantation
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called Dacogen
- Dose finding study (cycle 1-cycle4)
- Indicated dose for 5 consecutive days every 28 days
- Cohort 1: 5mg/m2 of decitabine
- Cohort 2 and 3:Dose escalation up to 15mg/m2 using a mechanism-based pharmacokinetic / pharmacodynamic model
| Study group | Role | What they receive |
|---|---|---|
| Decitabine, MDS treatment, IV injection | Experimental | For the patients who achieve remission after allogeneic BMT and meet the enrollment criteria, decitabine will be given at a dose of 5mg/kg/day ~ 15mg/kg/day iv over 1 hour for 5 consecutive days starting 42-90 days after transplantation. The drug will be repeated every 4 weeks for up to 12 cycles. Receives: Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose and schedule finding of post-BMT Decitabine Treatment
To find the safe dose and schedule of administration of the drug decitabine that can be given to patients with higher risk MDS or secondary AML evolving from MDS who received allogeneic stem cell transplantation
Measured: For up to 2 years after the start of Decitabine
Secondary outcomes (1)
Transplant outcomes of Decitabine maintenance treatment following transplantation
To evaluate the benefit of maintenance therapy with decitabine in prolonging the duration of survival and relapse-free survival after allo-SCT.
To evaluate the effect of maintenance therapy with decitabine on donor chimerism,GVHD, and other transplant toxicities.
To evaluate the effect of maintenance therapy with decitabine on immune recovery including NK cells, Treg and Th17 T cells
Measured: For up to 2 years after the start of Decitabine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Principal investigator, Yoo-Jin Kim, Seoul St. Mary's Hospital
- Investigators
- Yoo-Jin Kim, MD, PhD, Principal investigator, Division of Hematology,Department of Internal Medicine,Catholic Blood and Marrow Transplantation Center,Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277484
- Sponsor's protocol ID
- DEC-KOR-9007
- Acronym
- PODAC
- Status last verified
- Nov 2015
- First submitted
- 14 Jan 2011
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bennett JM, Catovsky D, Daniel MT, Flandrin G, Galton DA, Gralnick HR, Sultan C. Proposals for the classification of the myelodysplastic syndromes. Br J Haematol. 1982 Jun;51(2):189-99.
PubMed 6952920Heaney ML, Golde DW. Myelodysplasia. N Engl J Med. 1999 May 27;340(21):1649-60. doi: 10.1056/NEJM199905273402107. No abstract available.
PubMed 10341278Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88.
PubMed 9058730Kolb HJ, Schattenberg A, Goldman JM, Hertenstein B, Jacobsen N, Arcese W, Ljungman P, Ferrant A, Verdonck L, Niederwieser D, van Rhee F, Mittermueller J, de Witte T, Holler E, Ansari H; European Group for Blood and Marrow Transplantation Working Party Chronic Leukemia. Graft-versus-leukemia effect of donor lymphocyte transfusions in marrow grafted patients. Blood. 1995 Sep 1;86(5):2041-50.
PubMed 7655033Cho BS, Kim YJ, Cho SG, Kim SY, Eom KS, Kim HJ, Lee S, Min CK, Kim DW, Lee JW, Min WS, Kim CC. The beneficial effect of chronic graft-versus-host disease on the clinical outcome of transplantation with fludarabine/busulfan-based reduced-intensity conditioning for patients with de novo myelodysplastic syndrome. Int J Hematol. 2007 Jun;85(5):446-55. doi: 10.1532/IJH97.A30616.
PubMed 17562624Kim YJ, Kim DW, Lee S, Min CK, Lee DG, Choi SM, Eom KS, Kim HJ, Lee JW, Min WS, Kim CC. Comparison of 2 preparative regimens for stem cell transplantation from HLA-matched sibling donors in patients with advanced myelodysplastic syndrome. Int J Hematol. 2005 Jul;82(1):66-71. doi: 10.1532/IJH97.A30501.
PubMed 16105763Kim SY, Cho SG, Cho BS, Kim MS, Eom KS, Kim YJ, Kim HJ, Lee S, Min CK, Kim DW, Lee JW, Min WS. Azacytidine treatment after discontinuation of immunosuppressants in patients with myelodysplastic syndrome and relapse after allo-SCT at a single center. Bone Marrow Transplant. 2010 Aug;45(8):1375-6. doi: 10.1038/bmt.2009.355. Epub 2009 Dec 21. No abstract available.
PubMed 20023706de Lima M, Giralt S, Thall PF, de Padua Silva L, Jones RB, Komanduri K, Braun TM, Nguyen HQ, Champlin R, Garcia-Manero G. Maintenance therapy with low-dose azacitidine after allogeneic hematopoietic stem cell transplantation for recurrent acute myelogenous leukemia or myelodysplastic syndrome: a dose and schedule finding study. Cancer. 2010 Dec 1;116(23):5420-31. doi: 10.1002/cncr.25500. Epub 2010 Jul 29.
PubMed 20672358Han S, Kim YJ, Lee J, Jeon S, Hong T, Park GJ, Yoon JH, Yahng SA, Shin SH, Lee SE, Eom KS, Kim HJ, Min CK, Lee S, Yim DS. Model-based adaptive phase I trial design of post-transplant decitabine maintenance in myelodysplastic syndrome. J Hematol Oncol. 2015 Oct 23;8:118. doi: 10.1186/s13045-015-0208-3.
PubMed 26497198
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm, Open Label, Phase I Study for Dose and Schedule Finding of Decitabine in Patients With Higher-risk MDS and MDS/AML Receiving Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01277484
- Acronym / sponsor ID
- PODAC / DEC-KOR-9007
- Conditions
- Myelodysplastic Syndrome, Acute Myeloid Leukemia
- Keywords
- decitabine, dose, schedule, safety, allogeneic stem cell transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- Jan 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Jan 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.
Brief Scientific Rationale:
Decitabine has been shown to be effective for treatment of MDS and associated with very limited extramedullary toxicity at the lower doses. Furthermore, the hypomethylating effects of decitabine require an extended period of therapy and are likely to be more beneficial in the setting of a minimal residual disease after transplantation. The drug might exert a cytoreductive effect on the MDS clone, but ex vivo expansion strategy using decitabine and HDAC inhibitor provides a potential to expand the number of hematopoietic stem cells. There are lots of evidence which showed the the drug have immunostimulatory effects and can be used to enhance graft-versus leukemia effects. And also, some investigator suggested that decitabine could induce FOXP3 expression, promoting the conversion of naïve T cells to Tregs which are known to suppress GVHD while maintaining GVL effect in allo-SCT setting. As such, decitabine is an ideal agent to be investigated in the post-transplant setting.
The investigators hypothesized that post-transplant maintenance therapy with decitabine may reduce relapse rate, which may maximize the beneficial effects from reduced TRM of ATG-containing FB4 or FB2 conditioning regimen in higher-risk MDS or AML evolving from MDS patients.
Detailed description
- Transplant course
- BMT from an HLA-matched sibling or a suitably matched (up to 2-allele mismatched) family or unrelated donor will be performed according to the policies of the institute.
- A preparative regimen will be started 6 days before the day of stem cell infusion
- Myeloablative-intensity conditioning regimen: FB4+ATG
- Reduced-intensity conditioning regimen; FB2+ATG
- Graft-versus-host disease prophylaxis
- Sibling transplant: Cyclosporine and short-course Methotrexate
- Unrelated transplant: Tacrolimus and short-course Methotrexate
- The dose of calcineurin inhibitors (cyclosporine and tacrolimus) will be gradually tapered from day 60 (for all sibling transplants) or day 90 (for all unrelated transplants) and discontinued within 2 or 3 months after SCT in the absence of graft-versus-host disease.
- Decitabine maintenance course
- For the patients who finish the above transplant procedure and meet the enrollment criteria, decitabine will be given at a dose of 5mg/m2/day ~ 15mg/m2/day iv over 1 hour for 5 consecutive days. The drug will be repeated every 4 weeks for up to 12 cycles.
- Dose escalation strategy between cohorts and between cycles in the same cohort patients will be based upon the quantitatively measured hematological toxicity (e.g., ANC or platelet count at nadir). In other words, a mechanism-based pharmacokinetic / pharmacodynamic model developed using sparsely sampled patients' PK data and toxicity response will be used to titrate next cycle doses for the patients and initial doses for new cohort patients. In other words, a mechanism-based pharmacokinetic / pharmacodynamic model developed using sparsely sampled patients' PK data and toxicity response will be used to titrate next cycle doses for the patients and initial doses for new cohort patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine, MDS treatment, IV injection | Experimental | Drug: DecitabineFor the patients who achieve remission after allogeneic BMT and meet the enrollment criteria, decitabine will be given at a dose of 5mg/kg/day ~ 15mg/kg/day iv over 1 hour for 5 consecutive days starting 42-90 days after transplantation. The drug will be repeated every 4 weeks for up to 12 cycles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with a diagnosis of MDS (IPSS intermediate-2 or higher) before allogeneic transplantation
- HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with 2 allele mismatch)
- Performance status < ECOG 2
- Acceptable organ function defined as:Serum creatinine < 1.5 times the institutional ULN,Serum bilirubin < 1.5 times the institutional ULN,AST, ALT and alkaline phosphatase < 3 times the institutional ULN.
- 6 to 10 weeks after alloHSCT
Key exclusion criteria (7 listed)
- HIV positive
- Active uncontrolled infection
- Pregnancy or breastfeeding
- patients who have residual disease after allo SCT or primary graft failure
- Uncontrolled grade 3- 4 acute GVHD
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 |
|---|---|---|
| DecitabineAlso: Dacogen1. Dose finding study (cycle 1-cycle4) * Indicated dose for 5 consecutive days every 28 days * Cohort 1: 5mg/m2 of decitabine * Cohort 2 and 3:Dose escalation up to 15mg/m2 using a mechanism-based pharmacokinetic / pharmacodynamic model | Drug | Decitabine, MDS treatment, IV injection |
Primary outcome
Dose and schedule finding of post-BMT Decitabine Treatment
Time frame: For up to 2 years after the start of Decitabine
To find the safe dose and schedule of administration of the drug decitabine that can be given to patients with higher risk MDS or secondary AML evolving from MDS who received allogeneic stem cell transplantation
1 secondary outcome
Transplant outcomes of Decitabine maintenance treatment following transplantation
Time frame: For up to 2 years after the start of Decitabine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Background: PubMed 6952920Bennett JM, Catovsky D, Daniel MT, Flandrin G, Galton DA, Gralnick HR, Sultan C. Proposals for the classification of the myelodysplastic syndromes. Br J Haematol. 1982 Jun;51(2):189-99.
- Background: PubMed 10341278Heaney ML, Golde DW. Myelodysplasia. N Engl J Med. 1999 May 27;340(21):1649-60. doi: 10.1056/NEJM199905273402107. No abstract available.
- Background: PubMed 9058730Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88.
- Background: PubMed 7655033Kolb HJ, Schattenberg A, Goldman JM, Hertenstein B, Jacobsen N, Arcese W, Ljungman P, Ferrant A, Verdonck L, Niederwieser D, van Rhee F, Mittermueller J, de Witte T, Holler E, Ansari H; European Group for Blood and Marrow Transplantation Working Party Chronic Leukemia. Graft-versus-leukemia effect of donor lymphocyte transfusions in marrow grafted patients. Blood. 1995 Sep 1;86(5):2041-50.
- Background: PubMed 17562624Cho BS, Kim YJ, Cho SG, Kim SY, Eom KS, Kim HJ, Lee S, Min CK, Kim DW, Lee JW, Min WS, Kim CC. The beneficial effect of chronic graft-versus-host disease on the clinical outcome of transplantation with fludarabine/busulfan-based reduced-intensity conditioning for patients with de novo myelodysplastic syndrome. Int J Hematol. 2007 Jun;85(5):446-55. doi: 10.1532/IJH97.A30616.
- Background: PubMed 16105763Kim YJ, Kim DW, Lee S, Min CK, Lee DG, Choi SM, Eom KS, Kim HJ, Lee JW, Min WS, Kim CC. Comparison of 2 preparative regimens for stem cell transplantation from HLA-matched sibling donors in patients with advanced myelodysplastic syndrome. Int J Hematol. 2005 Jul;82(1):66-71. doi: 10.1532/IJH97.A30501.
- Background: PubMed 20023706Kim SY, Cho SG, Cho BS, Kim MS, Eom KS, Kim YJ, Kim HJ, Lee S, Min CK, Kim DW, Lee JW, Min WS. Azacytidine treatment after discontinuation of immunosuppressants in patients with myelodysplastic syndrome and relapse after allo-SCT at a single center. Bone Marrow Transplant. 2010 Aug;45(8):1375-6. doi: 10.1038/bmt.2009.355. Epub 2009 Dec 21. No abstract available.
- Background: PubMed 20672358de Lima M, Giralt S, Thall PF, de Padua Silva L, Jones RB, Komanduri K, Braun TM, Nguyen HQ, Champlin R, Garcia-Manero G. Maintenance therapy with low-dose azacitidine after allogeneic hematopoietic stem cell transplantation for recurrent acute myelogenous leukemia or myelodysplastic syndrome: a dose and schedule finding study. Cancer. 2010 Dec 1;116(23):5420-31. doi: 10.1002/cncr.25500. Epub 2010 Jul 29.
- Derived from this study: PubMed 26497198Han S, Kim YJ, Lee J, Jeon S, Hong T, Park GJ, Yoon JH, Yahng SA, Shin SH, Lee SE, Eom KS, Kim HJ, Min CK, Lee S, Yim DS. Model-based adaptive phase I trial design of post-transplant decitabine maintenance in myelodysplastic syndrome. J Hematol Oncol. 2015 Oct 23;8:118. doi: 10.1186/s13045-015-0208-3.
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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.
Yoo-Jin Kim, MD, PhD principal investigator
Division of Hematology,Department of Internal Medicine,Catholic Blood and Marrow Transplantation Center,Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Decitabine in people with Myelodysplastic Syndrome and Acute Myeloid Leukemia, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 20 Nov 2015. 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 South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Dose and schedule finding of post-BMT Decitabine Treatment (time frame: For up to 2 years after the start of Decitabine). 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 NCT01277484, which also lists 9 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 20 Nov 2015.