Acute Myeloid LeukaemiaPhase 1SCRAMBLENCT02189824
Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
A Phase 1 study testing Partially HLA-matched unrelated donor cells in people with Acute Myeloid Leukaemia, run by University of Sydney at 1 site in Australia.
Trial summary
A phase 1 study of infusion of partially HLA matched unrelated donor blood or marrow cells (microtransplantation) following consolidation chemotherapy in patients with AML that are not suitable for allogenic stem cell transplantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukaemia
- What is being tested?
- Partially HLA-matched unrelated donor cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2014to Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed AML not considered suitable for allogenic stem cell transplant on the basis of age or co-morbidities
- Complete morphological remission following 1-2 cycles of induction chemotherapy consisting of an anthracycline/cytosine arabinoside combination
- Availability of cryopreserved donor stem cells or bone marrow with appropriate HLA matching
- Adequate hepatic and renal function
- Estimated life expectancy of at least 6 months
- Patient has given informed consent or in the event of a patient not able to give informed consent, consent has been given according to hospital procedures in force at the time of trial
Who cannot join
- Patient not in morphological remission following 2 cycles of induction chemotherapy
- Use of fludarabine or other purine analogue during remission induction or use of any major immunosuppressive medication or any other immunomodulatory agent including thalidomide, lenalidomide, or azacitidine immediately prior to concurrent with administration of chemotherapy for AML or during or in the 3 months after administration of partially HLA matched 3rd party cells
- Absence of a cryopreserved donor stem cell or bone marrow product with appropriate matching
- Presence of significant hepatic, renal or other major organ dysfunction
- Uncontrolled infection or bleeding prior to commencement of consolidation chemotherapy
- Privately insured in or outpatient on the day the consent is signed and the days that cryopreserved partially HLA matched donor cells are infused
Trial locations and contacts
1 site in 1 country.
Emily Blyth contact
Australia1 site, 1 recruiting
- Recruiting
Westmead Hospital Department of Haematology
Westmead, Sydney, New South Wales, 2145
Emily Blyth, +61 2 9845 6274, emily.blyth@sydney.edu.au
David Gottlieb
About this study
A phase 1 study of infusion of partially HLA matched unrelated donor blood or marrow cells (microtransplantation) following consolidation chemotherapy in patients with AML that are not suitable for allogenic stem cell transplantation.
Read the detailed description
To determine the safety and tolerability of co-administration of partially HLA antigen matched unrelated donor cryopreserved donor lymphocytes (microtransplantation) with chemotherapy for patients with high risk acute myeloid leukaemia ineligible or unsuitable for high dose chemotherapy and stem cell transplantation.
- Conditions
- Acute Myeloid Leukaemia
- Being tested
- Partially HLA-matched unrelated donor cells
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially HLA-matched unrelated donor cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| Infusion of partially matched unrelated donor cells | Experimental | Not described Receives: Biological: Partially HLA-matched unrelated donor cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes
Measured: 60 days
Secondary outcomes (3)
Duration of post chemotherapy cytopenias
Measured: 60 days
Remission rate
Measured: 12 months
Duration of complete remission
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 posted15 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukaemiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Melbourne Health, Royal Brisbane and Women's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189824
- Sponsor's protocol ID
- SCTL141501
- Other IDs
- PG1061252
- Acronym
- SCRAMBLE
- Status last verified
- Oct 2015
- First submitted
- 11 Jul 2014
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02189824
- Acronym / sponsor ID
- SCRAMBLE / SCTL141501
- Conditions
- Acute Myeloid Leukaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Melbourne Health, Royal Brisbane and Women's Hospital
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 15 Jul 2014 (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.
A phase 1 study of infusion of partially HLA matched unrelated donor blood or marrow cells (microtransplantation) following consolidation chemotherapy in patients with AML that are not suitable for allogenic stem cell transplantation.
Detailed description
To determine the safety and tolerability of co-administration of partially HLA antigen matched unrelated donor cryopreserved donor lymphocytes (microtransplantation) with chemotherapy for patients with high risk acute myeloid leukaemia ineligible or unsuitable for high dose chemotherapy and stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infusion of partially matched unrelated donor cells | Experimental | Biological: Partially HLA-matched unrelated donor cells |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed AML not considered suitable for allogenic stem cell transplant on the basis of age or co-morbidities
- Complete morphological remission following 1-2 cycles of induction chemotherapy consisting of an anthracycline/cytosine arabinoside combination
- Availability of cryopreserved donor stem cells or bone marrow with appropriate HLA matching
- Adequate hepatic and renal function
- Estimated life expectancy of at least 6 months
Key exclusion criteria (6 listed)
- Patient not in morphological remission following 2 cycles of induction chemotherapy
- Use of fludarabine or other purine analogue during remission induction or use of any major immunosuppressive medication or any other immunomodulatory agent including thalidomide, lenalidomide, or azacitidine immediately prior to concurrent with administration of chemotherapy for AML or during or in the 3 months after administration of partially HLA matched 3rd party cells
- Absence of a cryopreserved donor stem cell or bone marrow product with appropriate matching
- Presence of significant hepatic, renal or other major organ dysfunction
- Uncontrolled infection or bleeding prior to commencement of consolidation chemotherapy
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 |
|---|---|---|
| Partially HLA-matched unrelated donor cells | Biological | Infusion of partially matched unrelated donor cells |
Primary outcome
Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes
Time frame: 60 days
3 secondary outcomes
Duration of post chemotherapy cytopenias
Time frame: 60 days
Remission rate
Time frame: 12 months
Duration of complete remission
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
Related trials for Acute Myeloid Leukaemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Emily Blyth contact
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 Partially HLA-matched unrelated donor cells in people with Acute Myeloid Leukaemia, run by University of Sydney at 1 site in Australia.
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 6 inclusion and 6 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 2 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 Australia. 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?
Contact Emily Blyth (emily.blyth@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes (time frame: 60 days). 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 2 Nov 2015.