Acute Myeloid LeukemiaPhase 1/2NCT00242515
T-cell Depleted Donor Lymphocyte Infusion (DLI)for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
A Phase 1/2 study testing CD8+ T-cell depleted donor lymphocyte infusion in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Primary Objectives: This a pilot project to determine the feasibility of the preemptive CD8+ depleted T-cell donor lymphocyte infusion (DLI) in: Reducing the incidence of graft versus host disease (GVHD) based on standard classification of acute and chronic GVHD Improving hte disease remission rate in comparison with… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- CD8+ T-cell depleted donor lymphocyte infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2005to Mar 2008
- Phase
- Phase 1/2
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of AML or high risk MDS in the following disease stages: Induction failure, first or subsequent remission, or untreated first relapse.
- Patient must have an HLA-compatible donor willing and capable of donating peripheral blood stem cells preferably or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (HLA-compatible defined as 5/6 or 6/6 matched related or 6/6 molecular matched unrelated donor)
- Both patient and donor must sign written informed consent forms.
- Patients must have:
- ECOG PS </= 2;
- Ejective fraction > 40%;
Show all 11Show fewer
- DLCO > 40% of predicted;
- Serum bilirubin </= 1.5x institutional upper limit of normal;
- SGPT (ALT) and SGOT (AST) </= 2.5x institutional upper limit of normal;
- Serum creatinine </= 2x upper limit of normal;
- Creatinine clearance >/= 60mL/min. However, renal dysfunction is not an absolute contraindication for NMT as dialysis can be performed during NMT.
Who cannot join
- Not fulfilling any of the inclusion criteria
- Active life-threatening infection
- Overt untreated infection
- HIV positivity, hepatitis B or C antigen positivity with active hepatitis
- Pregnant or lactating women
- Donor contraindication (HIV seropositive confirmed by Western blot; hepatitis B antigenemia)
- Unable to donate bone marrow or peripheral blood due to concurrent medical condition
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Department of Hematology-Oncology, National University Hospital
Singapore, 119074
About this study
Official title: Preemptive CD8+ T-cell Depleted Donor Lymphocyte Infusion (DLI) Following Nonmyeloablative Stem Cell Transplantation (NMT) for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
Primary Objectives:
This a pilot project to determine the feasibility of the preemptive CD8+ depleted T-cell donor lymphocyte infusion (DLI) in:
- Reducing the incidence of graft versus host disease (GVHD) based on standard classification of acute and chronic GVHD
- Improving hte disease remission rate in comparison with our previous study results.
Secondary Objectives:
- To investigate the impact of CD8+ depleted T-cell DLI in hematopoietic chimerism, and immunologic recovery of transplant patients.
Read the detailed description
The scientific investigation in this study protocol:
- Define the role of preemptive and specific DLI in preserving the GVL effect in the setting of NMT. The ability of selecting components of T cells for transplant and DLI will allow us to test the hypothesis of distinctive roles in subsets of T cells. It was found that CD8-depleted DLI was administered to prevent relapse after TCD (T-cell depleted) BMT (bone marrow as the stem cell source) or CD34-selected PBSC. Whether preemptive CD8-depleted DLI can perform this function after nonmyeloablative transplantation (NMT) needs to be established, as proposed in our study. If there turns out to be a role for DLI in these circumstances, a CD8-depleted lymphocyte product that can limit GVHD would be a very attractive option. We would also define the relationship of the level of donor chimerism and disease control.
- Investigate the impact of CD8-depleted DLI in NMT at specific doses and time points for the reduction of GVHD. The GVHD pattern may vary between different ethnic populations as suggested by our earlier NMT study. Our current proposed study will further shed light on the optimal GVHD prophylaxis regimen in the Singapore patient population.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- CD8+ T-cell depleted donor lymphocyte infusion
- Keywords
- High risk Myelodysplastic Syndrome (MDS)
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD8+ T-cell depleted donor lymphocyte infusionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of acute and chronic GVHD
Disease remission rate post CD8+ depleted T-cell DLI
Secondary outcomes (1)
Hematopoietic chimerism and immunologic recovery post CD8+ depleted T-cell DLI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startMar 2005
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Chien-Shing Chen, MD, Principal investigator, National University Hospital/National University Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242515
- Sponsor's protocol ID
- TP02/28/04
- Status last verified
- Jan 2014
- First submitted
- 19 Oct 2005
- Last updated
- 8 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive CD8+ T-cell Depleted Donor Lymphocyte Infusion (DLI) Following Nonmyeloablative Stem Cell Transplantation (NMT) for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT00242515
- Acronym / sponsor ID
- TP02/28/04
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- High risk Myelodysplastic Syndrome (MDS)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- Mar 2005
- Study completion
- Mar 2008
- First posted
- 20 Oct 2005 (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.
Primary Objectives:
This a pilot project to determine the feasibility of the preemptive CD8+ depleted T-cell donor lymphocyte infusion (DLI) in:
- Reducing the incidence of graft versus host disease (GVHD) based on standard classification of acute and chronic GVHD
- Improving hte disease remission rate in comparison with our previous study results.
Secondary Objectives:
- To investigate the impact of CD8+ depleted T-cell DLI in hematopoietic chimerism, and immunologic recovery of transplant patients.
Detailed description
The scientific investigation in this study protocol:
- Define the role of preemptive and specific DLI in preserving the GVL effect in the setting of NMT. The ability of selecting components of T cells for transplant and DLI will allow us to test the hypothesis of distinctive roles in subsets of T cells. It was found that CD8-depleted DLI was administered to prevent relapse after TCD (T-cell depleted) BMT (bone marrow as the stem cell source) or CD34-selected PBSC. Whether preemptive CD8-depleted DLI can perform this function after nonmyeloablative transplantation (NMT) needs to be established, as proposed in our study. If there turns out to be a role for DLI in these circumstances, a CD8-depleted lymphocyte product that can limit GVHD would be a very attractive option. We would also define the relationship of the level of donor chimerism and disease control.
- Investigate the impact of CD8-depleted DLI in NMT at specific doses and time points for the reduction of GVHD. The GVHD pattern may vary between different ethnic populations as suggested by our earlier NMT study. Our current proposed study will further shed light on the optimal GVHD prophylaxis regimen in the Singapore patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Confirmed diagnosis of AML or high risk MDS in the following disease stages: Induction failure, first or subsequent remission, or untreated first relapse.
- Patient must have an HLA-compatible donor willing and capable of donating peripheral blood stem cells preferably or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (HLA-compatible defined as 5/6 or 6/6 matched related or 6/6 molecular matched unrelated donor)
- Both patient and donor must sign written informed consent forms.
- Patients must have:
Key exclusion criteria (7 listed)
- Not fulfilling any of the inclusion criteria
- Active life-threatening infection
- Overt untreated infection
- HIV positivity, hepatitis B or C antigen positivity with active hepatitis
- Pregnant or lactating women
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 |
|---|---|---|
| CD8+ T-cell depleted donor lymphocyte infusion | Procedure or surgery | – |
Primary outcome
Incidence rate of acute and chronic GVHD
Disease remission rate post CD8+ depleted T-cell DLI
1 secondary outcome
Hematopoietic chimerism and immunologic recovery post CD8+ depleted T-cell DLI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
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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.
Chien-Shing Chen, MD principal investigator
National University Hospital/National University Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD8+ T-cell depleted donor lymphocyte infusion in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by National University Hospital, Singapore at 1 site in Singapore.
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 11 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 8 Jan 2014. 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 Singapore. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Shing Chen, MD (67724613, mdcccs@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of acute and chronic GVHD. 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?
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 8 Jan 2014.