Acute Myelogenous LeukemiaPhase 3NCT01854567
P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
A Phase 3 study testing Infusion of one MPC expanded cord unit and one unexpanded cord unit and Infusion of two unexpanded cord blood units. in people with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia, run by Mesoblast, Ltd. at 9 sites in United States.
Trial summary
The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma
- What is being tested?
- Infusion of one MPC expanded cord unit and one unexpanded cord unit and Infusion of two unexpanded cord blood units.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2013to 5 May 2017
- Phase
- Phase 3
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must have one of the following:
- Acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
- Acute lymphoblastic leukemia (ALL) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
- Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant.
- Hodgkin's disease: High risk subjects with responsive disease after first relapse.
- Minimum Karnofsky Scale
Show all 9Show fewer
- Subject must weigh at least 20 kg
- Up to 65 years of age
- Adequate major organ system function
Who cannot join
- Pregnancy and/or lactating
- Suitable, 6/6 HLA matched related sibling donor available
- Previous participation in a stem cell study within last 30 days
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Case Western
Cleveland, Ohio, 44106
MD Anderson Cancer Center
Houston, Texas, 77030
University of Miami Health System Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell-New York Presbyterian Hospital
New York, New York, 10065
Texas Transplant Center at Methodist Healthcare System
San Antonio, Texas, 78229
Moffitt Cancer Center
Tampa, Florida, 33612
Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment
The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease
- Being tested
- Infusion of one MPC expanded cord unit and one unexpanded cord unit, Infusion of two unexpanded cord blood units.
- Keywords
- Cord Blood, Stem Cells, MPC, Mesoblast, Expanded, AML, ALL, NHL, Leukemia, Lymphoma
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Hodgkin Disease, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of one MPC expanded cord unit and one unexpanded cord unitBiological
Infusion of one MPC expanded cord unit and one unexpanded cord unit.
Infusion of two unexpanded cord blood units.Biological
Umbilical Cord Blood.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Infusion of one MPC expanded cord unit and one unexpanded cord unit. Receives: Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unit |
| Control | Active comparator | Infusion of two unexpanded cord blood units. Receives: Biological: Infusion of two unexpanded cord blood units. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Neutrophil and Platelet Engraftment
Measured: 100 days
Secondary outcomes (2)
Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100
Measured: 100 days
Percentage of patients with primary graft failure
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startAug 2013
- Primary completion23 Sep 2016
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous LeukemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donna Skerrett, MD, MS, Study director, Mesoblast, Ltd.Elizabeth J. Shpall, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854567
- Sponsor's protocol ID
- CB-AB006
- Other IDs
- 2012-0166
- Status last verified
- Jun 2020
- First submitted
- 13 May 2013
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment
- ClinicalTrials.gov ID
- NCT01854567
- Acronym / sponsor ID
- CB-AB006
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, Hodgkin's Disease
- Keywords
- Cord Blood, Stem Cells, MPC, Mesoblast, Expanded, AML, ALL, NHL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Mesoblast, Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2013 (actual)
- Primary completion
- 23 Sep 2016 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 15 May 2013 (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 study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unitInfusion of one MPC expanded cord unit and one unexpanded cord unit. |
| Control | Active comparator | Biological: Infusion of two unexpanded cord blood units.Infusion of two unexpanded cord blood units. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient must have one of the following:
- Minimum Karnofsky Scale
- Subject must weigh at least 20 kg
- Up to 65 years of age
- Adequate major organ system function
Key exclusion criteria (3 listed)
- Pregnancy and/or lactating
- Suitable, 6/6 HLA matched related sibling donor available
- Previous participation in a stem cell study within last 30 days
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 |
|---|---|---|
| Infusion of one MPC expanded cord unit and one unexpanded cord unitInfusion of one MPC expanded cord unit and one unexpanded cord unit. | Biological | Active |
| Infusion of two unexpanded cord blood units.Umbilical Cord Blood. | Biological | Control |
Primary outcome
Time to Neutrophil and Platelet Engraftment
Time frame: 100 days
2 secondary outcomes
Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100
Time frame: 100 days
Percentage of patients with primary graft failure
Time frame: 100 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
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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.
Donna Skerrett, MD, MS study director
Mesoblast, Ltd.
Elizabeth J. Shpall, MD principal investigator
M.D. Anderson Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infusion of one MPC expanded cord unit and one unexpanded cord unit and Infusion of two unexpanded cord blood units. in people with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia, run by Mesoblast, Ltd. at 9 sites 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 9 inclusion and 3 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: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Neutrophil and Platelet Engraftment (time frame: 100 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 26 Jun 2020.