Acute Myeloid LeukemiaPhase 1NCT05569512
Uproleselan With Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for AML
A Phase 1 study testing Uproleselan, Fludarabine and Clofarabine in people with Acute Myeloid Leukemia and Pediatric Cancer, run by Malika Kapadia at 5 sites in United States.
Trial summary
This research study is studying a new drug, uproleselan, to see if it is safe and effective in decreasing relapse after stem cell transplant and improving leukemia-free survival in pediatric patients with acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 12 months to 39 years
- Conditions the study is for
- Acute Myeloid Leukemia, Pediatric Cancer
- What is being tested?
- Uproleselan, Fludarabine and Clofarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Oct 2022to 6 Dec 2023
- 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 12 months to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥12 months and ≤ 39 years
- The minimum and maximum number of subjects enrolled on the study are 20 and 28, respectively. In order to ensure at least 70% of the population are under the age of 18 years of age, the number of subjects >=18 years old will be limited as follows:
- At least 7 of the first 10 subjects must be under 18 years old
- At least 7 of the second 10 subjects must be under 18 years old
- At least 6 of the last 8 subjects enrolled must be under 18 years old
- Lansky/Karnofsky performance status ≥70% (see Appendix A)
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- Weight ≥10 kg
- Acute myeloid leukemia that arises de novo or is secondary to:
- cytotoxic chemoradiotherapy
- myelodysplastic syndrome
- a leukemia predisposition syndrome or inherited marrow failure syndrome other than ones associated with transplant-related morbidity and mortality. A predisposition resulting from a germline RUNX1 mutation is example of an eligible disorder. Fanconi Anemia and Dyskeratosis Congenita are examples of ineligible disorders.
- Disease status: Multidimensional flow cytometry (MDF) to assess disease status for eligibility will be performed centrally by Hematologics.
- In a first or second complete remission (defined as marrow with ≤1% leukemic blasts by MDF and no evidence of extramedullary disease) with minimal residual disease (MRD, defined as marrow with ≥0.05% leukemic blasts by MDF) after at least 2 cycles of induction/re-induction chemotherapy.
- Have newly diagnosed disease or disease in first relapse that is refractory (defined as marrow with >1% leukemic blasts by MDF or persistence of extramedullary disease) to at least 2 cycles of induction/re-induction chemotherapy.
- This sample will be used for eligibility as well as correlative biomarkers. Please see section 9.2 for details regarding collection, processing, and shipping of the sample.
- Graft and Donor Types:
- Patients must be receiving bone marrow or peripheral blood stem cells from a HLA identical related or HLA matched unrelated (allele level matched at A, B, C and DRB1 loci) donor.
- Eligibility of prospective donors should be determined in compliance with requirements of 21 CFR Part 1271. This should include donor screening for COVID-19 exposure or infection. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/updated-information-human-cell-tissue-or-cellular-or-tissue-based-product-hctp-establishments
- Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.
Who cannot join
- Participants who have had a previous hematopoietic stem cell transplantation
- Participants who have had prior treatment with uproleselan
- CNS 3 disease at time of admission for HSCT. Patients previously diagnosed CNS 3 disease that has improved (CNS1 or CNS2) will be eligible. (See Section 3.3 for definitions).
- Down Syndrome
- Fanconi Anemia, Dyskeratosis Congenita and other disorders associated with excess risk for transplant related toxicities
- Acute Promyelocytic Leukemia
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- Multiply relapsed (≥2) disease
- Pregnancy (positive serum beta-HCG) or breastfeeding Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with uproleselan, breastfeeding should be discontinued if the mother is treated with uproleselan. These potential risks also apply to other agents used in this study.
- Absolute neutrophil count <300/μL due to treatment (chemotherapy or immunotherapy).
- Patients with neutropenia due to disease related marrow dysfunction (refractory disease, underlying myelodysplasia or an underlying marrow failure disorder) will be eligible regardless of the absolute neutrophil count. However, enrolling centers must provide clear evidence that the neutrophil count is not rising, that the patient does not have an inadequately controlled infection (see section 3.2.15), and that the patient is on broad anti-fungal prophylaxis. Given the serious risk associated with starting conditioning in patients with severe neutropenia, centers are encouraged to delay transplant if they have any reason to believe that the absolute neutrophil count may improve.
- Estimated GFR of <60 mL/min/1.73 m2. Estimated GFR may be calculated using the CKD-EPI Creatinine Equation (2009) for patients ≥19 years or creatinine-based Bedside Schwartz equation (2009) for patients <19 years. It is recommended that estimates be determined using the calculators found on the National Kidney Foundation website. the (https://www.kidney.org/professionals/KDOQI/gfr_calculator). Any patient for whom these equations yields a GFR less than 90 mL/min/1.73 m2 should have radionucleotide testing. Measurement of 24-hour urine creatinine clearance is not an acceptable substitute for radionucleotide testing.
- Cardiac ejection fraction <50% or shortening fraction <27%
- Total bilirubin (with elevated direct bilirubin) or ALT >2 X ULN.
- Pulmonary disease with FVC, FEV1 or DLCO (corrected for hemoglobin) <50 % predicted or requiring supplemental oxygen. Children who are developmentally unable to perform pulmonary function testing will be assessed solely on their need for supplemental oxygen
- Active hepatitis B or C infection
- Active, poorly controlled infections. In patients being treated for infection at the time of enrollment, source documentation of the results of all microbiologic, radiographic and pathology assessments performed for diagnosis and for evaluation of response to treatment will be required.
- Patients with a known history of HIV are excluded, unless they meet all of the following conditions:
- No history of HIV complications with the exception of CD4 count <200 cells/mm3
- No antiretroviral therapy with overlapping toxicity such as myelosuppression
- CD4 count >500 cells/mm3 prior to the diagnosis of relapsed AML
- HIV viral loads below the limit of detection
- No history of highly active antiretroviral therapy (HAART)-resistant HIV
- Patients who have received another investigational drug within 28 days or 5 half-lives (whichever is longer).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama Birmingham
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Helen DeVos Children's Hospital/Spectrum Health
Grand Rapids, Michigan, 49503
Memorial Sloan Kettering Cancer Center
New York, New York, 10174
About this study
Official title: A Phase 1/2 Trial of Uproleselan Combined With High Dose Busulfan Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for Patients With Chemotherapy Resistant Acute Myeloid Leukemia
This research study is studying a new drug, uproleselan, to see if it is safe and effective in decreasing relapse after stem cell transplant and improving leukemia-free survival in pediatric patients with acute myeloid leukemia (AML).
The name of the study drugs involved in this study are:
- Uproleselan
- Busulfan
- Clofarabine
- Fludarabine
- Tacrolimus
- Methotrexate
- Mycophenolate Mofetil
Read the detailed description
This is a single arm, multi-center, phase 1/2 trial involving the use of the study drug, uproleselan, as part of the pre stem cell transplant conditioning regimen for pediatric patients with acute myeloid leukemia (AML). This study is looking to learn what dose of uproleselan should be given and the safety of uproleselan when combined with other drugs as part of the pre stem cell transplant conditioning regimen.
The U.S. Food and Drug Administration (FDA) has not approved uproleselan as a treatment for any disease. This is the first time that uproleselan will be given to children. Uproleselan is expected to treat acute myeloid leukemia (AML) by making AML cells sensitive to chemotherapy drugs that are part of standard of care pre-transplant conditioning regimen which could help make the transplant more effective..The standard of care conditioning regimen will include the drugs busulfan, clofarabine, and fludarabine. The standard of care drugs tacrolimus, and either methotrexate or mycophenolate mofetil will be used during the stem cell transplant course.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive study drug doses for 7 days before their stem cell transplant and will be followed for 2 years following their stem cell transplant.
It is expected that about 28 people will take part in this research study.
GlycoMimetics, Inc., a pharmaceutical company, is supporting this research study by providing the study drug (uproleselan) and funding for some of the laboratory tests.
On 7/26/24 the Sponsor-Investigator was notified GlycoMimetics, Inc. was terminating contracting for NCT05569512 following company restructuring. One subject was enrolled on the study prior to termination. The study did not proceed from Phase 1 to Phase 2.
- Conditions
- Acute Myeloid Leukemia, Pediatric Cancer
- Being tested
- Uproleselan, Fludarabine, Clofarabine, Busulfan
- Keywords
- Acute Myeloid Leukemia, Pediatric Cancer
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UproleselanDrug
Administered by intravenous infusion
FludarabineDrug
Also called Fludara
Administered by intravenous infusion
ClofarabineDrug
Also called Clolar
Administered by intravenous infusion
BusulfanDrug
Also called Busulfex, Myleran
Administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Uproleselan with pre-transplant conditioning | Experimental | Participants will receive IV uproleselan on day -8 prior to stem cell transplant. Uproleselan will be administered IV twice daily from day -7 through day -2.
Participants will also receive a standard pre-transplant conditioning regimen with fludarabine, clofarabine and busulfan. Each of these 3 drugs will be administered IV once daily from day -7 through day -4. Receives: Drug: Uproleselan; Drug: Fludarabine; Drug: Clofarabine; Drug: Busulfan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommend Phase 2 Dose
Dose recommended by study team based on maximum tolerated dose (MTD). Highest dose level at or below the maximally administered dose where ≤1 out of 6 patients experienced a Dose Limiting Toxicity (DLT)
Measured: Day -8 pre- transplant through post-transplant Day +30
Dose Limiting Toxicity (DLT) Phase 1
All observed toxicities will be summarized using frequencies, proportions, and 95% confidence intervals by type (organ affected or laboratory determination), severity (by CTCAEv5.0), attribution, and expectedness. Only the maximum grade for each type of toxicity will be tabulated for each patient.
Measured: Transplant Day 0 through post-transplant Day +30
Dose Limiting Toxicity (DLT) Phase 2
All observed toxicities will be summarized using frequencies, proportions, and 95% confidence intervals by type (organ affected or laboratory determination), severity (by CTCAEv5.0), attribution, and expectedness. Only the maximum grade for each type of toxicity will be tabulated for each patient.
Measured: Transplant Day 0 through post-transplant Day +30
Secondary outcomes (5)
Uproleselan Pharmacokinetics
Blood samples will be drawn for measurement of uproleselan plasma levels with the day -8 dose and the first day -4 dose. Four 1 ml samples will be drawn each day for patients less than 6 years. Five 2 ml samples will be drawn each day for patients 6 years and older. Measurements will be used to estimate uproleselan area under the curve.
Measured: Day -8 pre-transplant to day -4 pre- transplant
12-month Leukemia-Free Survival (LFS)
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria:
Measured: 12 months
Overall Survival (OS)
Overall Survival (OS) is based on the Kaplan-Meier method and defined as the time from study entry to death or censored at date last known alive per immune RECIST (iRECIST)
Measured: Date of transplant (Day 0) to 2 years post stem cell transplant
Relapse Rate at the RP2D
Rate of Relapse defined as the proportion of patients that has relapse on treatment or during the follow-up period
Measured: Up to 2 years
Number of Patients with Severe Oral or Gastrointestinal Mucositis
Defined as all grade 3 or higher oral or gastrointestinal mucositis related adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5.
Measured: Between day 0 and post-transplant day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start6 Oct 2022
- Primary completion5 Oct 2023
- Study completion6 Dec 2023
Why it stopped: On 7/26/24 the Sponsor-Investigator was notified GlycoMimetics was terminating contracting for NCT05569512 following company restructuring. This notification came ahead of the study meeting criteria to progress from Phase 1 to Phase 2.
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malika Kapadia
- Sponsor type
- University, hospital or other
- Collaborators
- GlycoMimetics Incorporated
- Responsible party
- Sponsor-investigator, Malika Kapadia, Dana-Farber Cancer Institute
- Investigators
- Malika Kapadia, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569512
- Sponsor's protocol ID
- 22-063
- Status last verified
- Aug 2024
- First submitted
- 27 Sep 2022
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Trial of Uproleselan Combined With High Dose Busulfan Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for Patients With Chemotherapy Resistant Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05569512
- Acronym / sponsor ID
- 22-063
- Conditions
- Acute Myeloid Leukemia, Pediatric Cancer
- Keywords
- Acute Myeloid Leukemia, Pediatric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: On 7/26/24 the Sponsor-Investigator was notified GlycoMimetics was terminating contracting for NCT05569512 following company restructuring. This notification came ahead of the study meeting criteria to progress from Phase 1 to Phase 2.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Malika KapadiaUniversity, hospital or other
- Collaborators
- GlycoMimetics Incorporated
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 6 Oct 2022 (actual)
- 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.
This research study is studying a new drug, uproleselan, to see if it is safe and effective in decreasing relapse after stem cell transplant and improving leukemia-free survival in pediatric patients with acute myeloid leukemia (AML).
The name of the study drugs involved in this study are:
- Uproleselan
- Busulfan
- Clofarabine
- Fludarabine
- Tacrolimus
- Methotrexate
- Mycophenolate Mofetil
Detailed description
This is a single arm, multi-center, phase 1/2 trial involving the use of the study drug, uproleselan, as part of the pre stem cell transplant conditioning regimen for pediatric patients with acute myeloid leukemia (AML). This study is looking to learn what dose of uproleselan should be given and the safety of uproleselan when combined with other drugs as part of the pre stem cell transplant conditioning regimen.
The U.S. Food and Drug Administration (FDA) has not approved uproleselan as a treatment for any disease. This is the first time that uproleselan will be given to children. Uproleselan is expected to treat acute myeloid leukemia (AML) by making AML cells sensitive to chemotherapy drugs that are part of standard of care pre-transplant conditioning regimen which could help make the transplant more effective..The standard of care conditioning regimen will include the drugs busulfan, clofarabine, and fludarabine. The standard of care drugs tacrolimus, and either methotrexate or mycophenolate mofetil will be used during the stem cell transplant course.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive study drug doses for 7 days before their stem cell transplant and will be followed for 2 years following their stem cell transplant.
It is expected that about 28 people will take part in this research study.
GlycoMimetics, Inc., a pharmaceutical company, is supporting this research study by providing the study drug (uproleselan) and funding for some of the laboratory tests.
On 7/26/24 the Sponsor-Investigator was notified GlycoMimetics, Inc. was terminating contracting for NCT05569512 following company restructuring. One subject was enrolled on the study prior to termination. The study did not proceed from Phase 1 to Phase 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uproleselan with pre-transplant conditioning | Experimental | Drug: Uproleselan, Drug: Fludarabine, Drug: Clofarabine, Drug: BusulfanParticipants will receive IV uproleselan on day -8 prior to stem cell transplant. Uproleselan will be administered IV twice daily from day -7 through day -2. Participants will also receive a standard pre-transplant conditioning regimen with fludarabine, clofarabine and busulfan. Each of these 3 drugs will be administered IV once daily from day -7 through day -4. |
Who may qualify
- Ages
- 12 months to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Age ≥12 months and ≤ 39 years
- Lansky/Karnofsky performance status ≥70% (see Appendix A)
- Weight ≥10 kg
- Acute myeloid leukemia that arises de novo or is secondary to:
- Disease status: Multidimensional flow cytometry (MDF) to assess disease status for eligibility will be performed centrally by Hematologics.
Key exclusion criteria (23 listed)
- Participants who have had a previous hematopoietic stem cell transplantation
- Participants who have had prior treatment with uproleselan
- CNS 3 disease at time of admission for HSCT. Patients previously diagnosed CNS 3 disease that has improved (CNS1 or CNS2) will be eligible. (See Section 3.3 for definitions).
- Down Syndrome
- Fanconi Anemia, Dyskeratosis Congenita and other disorders associated with excess risk for transplant related toxicities
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 |
|---|---|---|
| UproleselanAdministered by intravenous infusion | Drug | Uproleselan with pre-transplant conditioning |
| FludarabineAlso: FludaraAdministered by intravenous infusion | Drug | Uproleselan with pre-transplant conditioning |
| ClofarabineAlso: ClolarAdministered by intravenous infusion | Drug | Uproleselan with pre-transplant conditioning |
| BusulfanAlso: Busulfex, MyleranAdministered by intravenous infusion | Drug | Uproleselan with pre-transplant conditioning |
Primary outcome
Recommend Phase 2 Dose
Time frame: Day -8 pre- transplant through post-transplant Day +30
Dose recommended by study team based on maximum tolerated dose (MTD). Highest dose level at or below the maximally administered dose where ≤1 out of 6 patients experienced a Dose Limiting Toxicity (DLT)
Dose Limiting Toxicity (DLT) Phase 1
Time frame: Transplant Day 0 through post-transplant Day +30
All observed toxicities will be summarized using frequencies, proportions, and 95% confidence intervals by type (organ affected or laboratory determination), severity (by CTCAEv5.0), attribution, and expectedness. Only the maximum grade for each type of toxicity will be tabulated for each patient.
Dose Limiting Toxicity (DLT) Phase 2
Time frame: Transplant Day 0 through post-transplant Day +30
All observed toxicities will be summarized using frequencies, proportions, and 95% confidence intervals by type (organ affected or laboratory determination), severity (by CTCAEv5.0), attribution, and expectedness. Only the maximum grade for each type of toxicity will be tabulated for each patient.
5 secondary outcomes
Uproleselan Pharmacokinetics
Time frame: Day -8 pre-transplant to day -4 pre- transplant
12-month Leukemia-Free Survival (LFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: Date of transplant (Day 0) to 2 years post stem cell transplant
Relapse Rate at the RP2D
Time frame: Up to 2 years
Number of Patients with Severe Oral or Gastrointestinal Mucositis
Time frame: Between day 0 and post-transplant day 14
Results and safety
The study was stopped early (reason given: On 7/26/24 the Sponsor-Investigator was notified GlycoMimetics was terminating contracting for NCT05569512 following company restructuring. This notification came ahead of the study meeting criteria to progress from Phase 1 to Phase 2.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Malika Kapadia, MD principal investigator
Dana-Farber Cancer Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Uproleselan, Fludarabine and Clofarabine in people with Acute Myeloid Leukemia and Pediatric Cancer, run by Malika Kapadia at 5 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 19 inclusion and 23 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 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
The study was stopped early (reason given: On 7/26/24 the Sponsor-Investigator was notified GlycoMimetics was terminating contracting for NCT05569512 following company restructuring. This notification came ahead of the study meeting criteria to progress from Phase 1 to Phase 2.). Results are not available in the source record.
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?
Recommend Phase 2 Dose (time frame: Day -8 pre- transplant through post-transplant Day +30). The study lists 3 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 19 Aug 2024.