Myelodysplastic SyndromeRICandDLINCT01252784
Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation
An observational study of Myelodysplastic Syndrome, run by Cooperative Study Group A for Hematology at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to Oct 2014
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with higher risk MDS
Who may be able to join
- Patients with higher risk MDS including chronic myelomonocytic leukemia
- RAEB-1 or RAEB-2
- IPSS Intermediate-2 or High risk category
- Chronic myelomonocytic leukemia
- Patients with appropriate hematopoietic cell donor
- HLA-matched sibling
- HLA-matched unrelated donor
- HLA-mismatched familial donor 3.16 years old or older
Who cannot join
- • Presence of significant active infection
- Presence of uncontrolled bleeding
- Any coexisting major illness or organ failure
- Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Asanbyeongwon-gil, Songpa-gu, 138-736
Yae-Eun Jang, nurse, 82-2-3010-6378, redpin75@paran.com
About this study
Official title: Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome
The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS.
Read the detailed description
Conditioning therapy
- Busulfan 3.2 mg/kg/d on d-7 to -6
- Fludarabine 30 mg/m2 on d-7 to -2
- ATG 1.5-3.0 mg/kg/d on d-3 to -1
- Methylpred 2 mg/kg/d on d-4 to -1
Mobilization and harvest
- Donor
- G-CSF 10 mcg/kg/d s.c. on d-3 to 0
- Harvest of PBMCs on d 0 to +1
Infuse G-PBMCs on d 0 to d+1.
- Donor G-PBMC infusion
GVHD prophylaxis
- Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and d+60.
- Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7
Prophylactic dose-escalating DLIs
- Begin at d+120 or at least 2 wks after IST discontinuation.
- No evidence of recurrence or GVHD CD3+ cell dose increment q 4 wks 4Three dose levels
- Conditions
- Myelodysplastic Syndrome
- Keywords
- higher risk MDS
- Medical subject headings
- Myelodysplastic Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse incidence,duration of remission
The efficacy of the treatment will be measured in terms of relapse incidence and duration of remission (the primary endpoints). The hematopoietic cell donors in the study will include HLA-matched sibling, HLA-matched unrelated donors, and HLA-mismatched familial donors.
Measured: 4years
Secondary outcomes (1)
engraftment, donor chimerism, secondary graft failure,GVHD
•This study will evaluate engraftment, donor chimerism, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, non-relapse mortality, progression-free survival (PFS), and OS.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooperative Study Group A for Hematology
- Sponsor type
- Research network
- Investigators
- Je-Hwan Lee, Doctor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252784
- Sponsor's protocol ID
- Allo-039
- Acronym
- RICandDLI
- Status last verified
- Nov 2010
- First submitted
- 1 Dec 2010
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT01252784
- Acronym / sponsor ID
- RICandDLI / Allo-039
- Conditions
- Myelodysplastic Syndrome
- Keywords
- higher risk MDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cooperative Study Group A for HematologyResearch network
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 3 Dec 2010 (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 this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS.
Detailed description
Conditioning therapy
- Busulfan 3.2 mg/kg/d on d-7 to -6
- Fludarabine 30 mg/m2 on d-7 to -2
- ATG 1.5-3.0 mg/kg/d on d-3 to -1
- Methylpred 2 mg/kg/d on d-4 to -1
Mobilization and harvest
- Donor
- G-CSF 10 mcg/kg/d s.c. on d-3 to 0
- Harvest of PBMCs on d 0 to +1
Infuse G-PBMCs on d 0 to d+1.
- Donor G-PBMC infusion
GVHD prophylaxis
- Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and d+60.
- Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7
Prophylactic dose-escalating DLIs
- Begin at d+120 or at least 2 wks after IST discontinuation.
- No evidence of recurrence or GVHD CD3+ cell dose increment q 4 wks 4Three dose levels
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with higher risk MDS
Key inclusion criteria (8 listed)
- Patients with higher risk MDS including chronic myelomonocytic leukemia
- Patients with appropriate hematopoietic cell donor
Key exclusion criteria (4 listed)
- • Presence of significant active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
relapse incidence,duration of remission
Time frame: 4years
The efficacy of the treatment will be measured in terms of relapse incidence and duration of remission (the primary endpoints). The hematopoietic cell donors in the study will include HLA-matched sibling, HLA-matched unrelated donors, and HLA-mismatched familial donors.
1 secondary outcome
engraftment, donor chimerism, secondary graft failure,GVHD
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
- Reduced-intensity conditioning allogeneic hematopoietic cell transplantation followed by prophylactic dose-escalating donor lymphocyte infusions in higher risk myelodysplastic syndromeLink provided by the sponsor.
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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.
Je-Hwan Lee, Doctor principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndrome, run by Cooperative Study Group A for Hematology 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 8 inclusion and 4 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 3 Dec 2010. 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.
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?
Contact Je-Hwan Lee, Doctor (82-2-3010-3218, jhlee3@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse incidence,duration of remission (time frame: 4years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2010.