Acute Myeloid Leukemia (AML)Phase 2NCT02648932
The Rapid Study: Randomized Phase II Study To Expedite Allogeneic Transplant With Immediate Haploidentical Plus Unrelated Cord Donor Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients
A Phase 2 study testing Haplo-Cord Transplant and Matched Unrelated Donor Transplant in people with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by University of Chicago at 1 site in United States.
Trial summary
The study seeks to compare time from formal search to hematopoietic cell transplantation (HCT) for patients 18 years and older, randomized between haplo-cord search and matched unrelated donor (MUD) search for patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
- What is being tested?
- Haplo-Cord Transplant and Matched Unrelated Donor Transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2016to Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of acute myeloid leukemia (AML) or high or very high-risk MDS by international prognostic scoring system revised for whom transplant is recommended
- 18 years of age or older
- Subject is likely to be considered for allogeneic transplant in the opinion of the transplant physician (based on age of patient, health, cytogenetics, and/or molecular characteristics).
- Karnofsky Performance Status (KPS) >/= 70% at time of enrollment. An exception will be made for those with lower KPS at enrollment with an acute worsening that is likely to resolve in the treating physicians judgment (e.g., reversible infection,trauma, medication reaction, etc)
- Ability to understand and the willingness to sign a written informed consent document for the Search Phase.
- Patient willing to consider HCT
Show all 22Show fewer
- A preliminary search has identified:
- An appropriate minimum 4/6 matched umbilical cord unit at intermediate resolution at HLA-A and B, and high resolution at HLA-DRB with a cell dose above 1 x 10(7) TNC/kg for a single umbilical cord blood (UCB) transplant AND
- At least one potential 8/8 HLA-matched (HLA-A, -B, -C, and -DRB1) unrelated donor with a probability of 70% AND
- Availability of a potential related haploidentical donor.
- High-risk AML for which transplant is recommend based on cytogenetic, molecular and morphologic features. Patients must meet institutional standards for disease control prior to transplant.
- For MDS. IPSS-revised criteria of high or very high at diagnosis.
- Subject meets institutional criteria for transplant and has acceptable organ and marrow function as defined below:
- Serum bilirubin < 2.0mg/dL unless Gilberts disease
- Creatinine Clearance > 45 mL/min.1.73m2 as estimated by modified MDRD equation
- Left ventricular function 40% or greater
- DLCO corrected for hemoglobin >50%
- KPS 70% or greater
- An adequate graft for the defined donor type
- Haplo-cord requires a haploidentical adult donor of 14 years of age and at least 50 kg, and a cord blood unit with at least 1.0 x 10(7) TNC/kg and a match of at least 4/6 by intermediate resolution for HLA-A and B and high resolution at DRB1. Donor provides standard of care consent for harvest following institutional policy. Any donor samples or donor research data would be obtained on separate donor research protocol.
- For MUD requires a 7/8 or 8/8 HLA matched unrelated donor with high resolution matching at HLA-A, -B, -C, and DRB1. DP matching or DP permissive should be achieved when possible using T-cell epitope strategy.
- Written informed consent for the transplant phase
Who cannot join
- Prior formal search was instituted
- Diagnosis of acute promyelocytic leukemia (APL)
- Known HLA matched related donor without contraindications to donate
- Life expectancy severely limited by concomitant illness or uncontrolled infection
- Life expectancy severely limited by concomitant illness or uncontrolled infection
- HIV-positive
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Cancer Center
Chicago, Illinois, 60637
About this study
Official title: The Rapid Study: Randomized (RA) Phase (P) II Study To Expedite Allogeneic Transplant With Immediate (I) Haploidentical Plus Unrelated Cord Donor (D) Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients
The study seeks to compare time from formal search to hematopoietic cell transplantation (HCT) for patients 18 years and older, randomized between haplo-cord search and matched unrelated donor (MUD) search for patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)
Read the detailed description
Primary Objectives
To compare time from formal search to hematopoietic cell transplantation (HCT) for patients 18 years and older, randomized between haplo-cord search and matched unrelated donor (MUD) search for patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)
Secondary Objectives
- To compare the percentage of patients who undergo HCT in each study cohort
- To evaluate overall survival from time to randomization by study cohort
- Being tested
- Haplo-Cord Transplant, Matched Unrelated Donor Transplant
- Keywords
- Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), hematopoietic cell transplantation, haplo-cord search, matched unrelated donor search
- 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.
Haplo-Cord TransplantBiological
For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device
Matched Unrelated Donor TransplantProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Haplo-Cord Search | Other | If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant. Receives: Biological: Haplo-Cord Transplant |
| Matched Unrelated Donor Search (MUD) | Other | If subject meets the inclusion criteria and consents, will undergo a MUD transplant. Receives: Procedure: Matched Unrelated Donor Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Transplant
Time to transplant will be measured from time of date of formal request to stem cell infusion date. Will also capture time from preliminary search to both formal search and transplant date.
Measured: Through one year after formal search
Secondary outcomes (2)
Percentage of Patients Who Undergo Hematopoietic Cell Transplantation (HCT)
Compare percentage of patients who undergo HCT in each study cohort
Measured: Through one year after formal search
Estimated Survival Time
Overall survival time was estimated from date of randomization and from date of transplant using Kaplan-Meier method.
Measured: From date of randomization up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start4 Feb 2016
- Primary completionApr 2020
- Study completionApr 2020
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Artz, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648932
- Sponsor's protocol ID
- IRB15-0866
- Status last verified
- Feb 2021
- First submitted
- 4 Jan 2016
- Last updated
- 18 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rapid Study: Randomized (RA) Phase (P) II Study To Expedite Allogeneic Transplant With Immediate (I) Haploidentical Plus Unrelated Cord Donor (D) Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients
- ClinicalTrials.gov ID
- NCT02648932
- Acronym / sponsor ID
- IRB15-0866
- Keywords
- Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), hematopoietic cell transplantation, haplo-cord search, matched unrelated donor search
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Posted 18 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study seeks to compare time from formal search to hematopoietic cell transplantation (HCT) for patients 18 years and older, randomized between haplo-cord search and matched unrelated donor (MUD) search for patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)
Detailed description
Primary Objectives
To compare time from formal search to hematopoietic cell transplantation (HCT) for patients 18 years and older, randomized between haplo-cord search and matched unrelated donor (MUD) search for patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)
Secondary Objectives
- To compare the percentage of patients who undergo HCT in each study cohort
- To evaluate overall survival from time to randomization by study cohort
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haplo-Cord Search | Other | Biological: Haplo-Cord TransplantIf subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant. |
| Matched Unrelated Donor Search (MUD) | Other | Procedure: Matched Unrelated Donor TransplantIf subject meets the inclusion criteria and consents, will undergo a MUD transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Diagnosis of acute myeloid leukemia (AML) or high or very high-risk MDS by international prognostic scoring system revised for whom transplant is recommended
- 18 years of age or older
- Subject is likely to be considered for allogeneic transplant in the opinion of the transplant physician (based on age of patient, health, cytogenetics, and/or molecular characteristics).
- Karnofsky Performance Status (KPS) >/= 70% at time of enrollment. An exception will be made for those with lower KPS at enrollment with an acute worsening that is likely to resolve in the treating physicians judgment (e.g., reversible infection,trauma, medication reaction, etc)
- Ability to understand and the willingness to sign a written informed consent document for the Search Phase.
Key exclusion criteria (6 listed)
- Prior formal search was instituted
- Diagnosis of acute promyelocytic leukemia (APL)
- Known HLA matched related donor without contraindications to donate
- Life expectancy severely limited by concomitant illness or uncontrolled infection
- Life expectancy severely limited by concomitant illness or uncontrolled infection
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 |
|---|---|---|
| Haplo-Cord TransplantFor conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device | Biological | Haplo-Cord Search |
| Matched Unrelated Donor Transplant | Procedure or surgery | Matched Unrelated Donor Search (MUD) |
Primary outcome
Time to Transplant
Time frame: Through one year after formal search
Time to transplant will be measured from time of date of formal request to stem cell infusion date. Will also capture time from preliminary search to both formal search and transplant date.
2 secondary outcomes
Percentage of Patients Who Undergo Hematopoietic Cell Transplantation (HCT)
Time frame: Through one year after formal search
Estimated Survival Time
Time frame: From date of randomization up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andrew Artz, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Haplo-Cord Transplant and Matched Unrelated Donor Transplant in people with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by University of Chicago at 1 site in United States.
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 22 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: stopped early, as of the sponsor's last update on 18 Mar 2021. 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 18 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Transplant (time frame: Through one year after formal search). 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 18 Mar 2021.