Acute Myeloid Leukemia in RemissionPhase 2NCT01894477
Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
A Phase 2 study testing Allogeneic Bone Marrow Transplantation, Fludarabine Phosphate and Peripheral Blood Stem Cell Transplantation in people with Acute Myeloid Leukemia in Remission and Chronic Myelomonocytic Leukemia, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This randomized phase II trial studies how well treosulfan and fludarabine phosphate, with or without total body irradiation before donor stem cell transplant works in treating patients with myelodysplastic syndrome or acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia in Remission, Chronic Myelomonocytic Leukemia, Minimal Residual Disease
- What is being tested?
- Allogeneic Bone Marrow Transplantation, Fludarabine Phosphate and Peripheral Blood Stem Cell Transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2022
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- MDS, myelodysplastic syndrome/myeloproliferative neoplasia overlap disorders (including chronic myelomonocytic leukemia [CMML], and MDS/myeloproliferative neoplasm [MPN] unclassifiable syndromes)
- AML, other than acute promyelocytic leukemia (APL), in first or second remission or with minimal residual disease
- With Karnofsky index or Lansky Play-Performance scale > 70% on pre-transplant evaluation
- Able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)
- Patients with previous autologous or allogeneic HCT are allowed to enroll
- DONOR: Human leukocyte antigen (HLA)-identical related donors or
Show all 10Show fewer
- DONOR: Unrelated donors matched for HLA-A, B, C, DRB1, and DQB1 as defined by high resolution deoxyribonucleic acid (DNA) typing; mismatch for one HLA allele is allowed
- DONOR: Donors able to undergo peripheral blood stem cell collection or bone marrow harvest
- DONOR: Donors in good general health, with a Karnofsky or Lansky play performance score > 90%
- DONOR: Donors able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)
Who cannot join
- Receiving umbilical cord blood
- With impaired cardiac function as evidenced by ejection fraction < 35% (or, if unable to obtain ejection fraction, shortening fraction of < 26%) or cardiac insufficiency requiring treatment or symptomatic coronary artery disease; patients with a shortening fraction < 26% may be enrolled if approved by a cardiologist
- With impaired pulmonary function as evidenced by partial pressure of oxygen (pO2) < 70 mm Hg and carbon monoxide diffusing capability test (DLCO) < 70% of predicted or pO2 < 80 mm Hg and DLCO < 60% of predicted; (or, for pediatric patients unable to perform pulmonary function tests, then oxygen (O2) saturation < 92% on room air), or receiving supplementary continuous oxygen
- With impaired renal function as evidenced by creatinine-clearance < 50% for age, weight, height or serum creatinine > 2 x upper limit of normal or dialysis-dependent
- With hepatic dysfunction as evidenced by total bilirubin > 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
- With hepatic dysfunction as evidenced by aspartate aminotransferase (AST) > 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
Show all 20Show fewer
- With active infectious disease requiring deferral of conditioning, as recommended by an infectious disease specialist
- With human immunodeficiency virus (HIV)-positivity or active infectious hepatitis
- With central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy, cranial irradiation or both prior to initiating conditioning (day -6)
- Patients with active non-hematological malignancies (except non-melanoma skin cancers) or those with non-hematological malignancies who have been rendered with no evidence of disease, but have a greater than 20% chance of having disease recurrence within 5 years; this exclusion does not apply to patients with non-hematologic malignancies that do not require therapy
- With life expectancy severely limited by diseases other than malignancy
- Women who are pregnant or lactating
- With known hypersensitivity to treosulfan or fludarabine (fludarabine phosphate)
- Receiving another experimental drug within 4 weeks before initiation of conditioning (day -6)
- Unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent
- DONOR: Individuals deemed unable to undergo marrow harvesting or PBSC mobilization and leukapheresis
- DONOR: Individuals who are HIV-positive
- DONOR: Individuals with active infectious hepatitis
- DONOR: Females with a positive pregnancy test
- DONOR: Persons unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Randomized Phase II Study of Treosulfan, Fludarabine and Low-Dose TBI as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)
This randomized phase II trial studies how well treosulfan and fludarabine phosphate, with or without total body irradiation before donor stem cell transplant works in treating patients with myelodysplastic syndrome or acute myeloid leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus before and mycophenolate mofetil after the transplant may stop this from happening.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the better of two treosulfan-based conditioning regimens in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), by comparing 6-month progression-free survival.
SECONDARY OBJECTIVES:
- Determine the effects of two conditioning regimens on changes in gene expression profiles, and evaluate the association of gene expression profiles and disease relapse.
II. Determine the incidence of progression-free survival at 1 year and 2 years after hematopoietic cell transplantation (HCT).
III. Evaluate overall survival (OS) at 6 months, at 1 year and at 2 years after HCT.
IV. Determine the incidence of grades II-IV acute graft-versus-host disease (GVHD).
- Determine the incidence of chronic GVHD.
VI. Determine donor chimerism around days +28 and +84.
CONDITIONING REGIMEN:
Arm A: Patients receive treosulfan intravenously (IV) over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
Arm B: Patients receive treosulfan and fludarabine phosphate as in Arm A and undergo low-dose total-body irradiation (TBI) on day 0.
TRANSPLANT: Patients in both arms undergo allogeneic peripheral blood stem cell (PBSC) transplant or bone marrow transplant on day 0.
GVHD PROPHYLAXIS: Patients with a related donor receive tacrolimus orally (PO) every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, patients also receive mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, patients also receive mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96.
NOTE: Patients with related donors eligible for FHCRC protocol 2545 may receive cyclosporine IV, instead of tacrolimus, beginning on day -3 to day 50 with a taper to day 180.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Acute Myeloid Leukemia in Remission, Chronic Myelomonocytic Leukemia, Minimal Residual Disease, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Being tested
- Allogeneic Bone Marrow Transplantation, Fludarabine Phosphate, Peripheral Blood Stem Cell Transplantation, Total-Body Irradiation, Treosulfan
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic, Neoplasm, Residual, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Bone Marrow TransplantationProcedure or surgery
Also called Allo BMT, Allogeneic BMT
Undergo allogeneic bone marrow transplant
Also called 2-F-ara-AMP, Beneflur, Fludara, SH T 586
Intravenously administered Fludarabine Phosphate
Peripheral Blood Stem Cell TransplantationProcedure or surgery
Also called PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplantation
Undergo allogeneic PBSC transplant
Total-Body IrradiationRadiation
Also called TOTAL BODY IRRADIATION, Whole-Body Irradiation
Undergo TBI
TreosulfanDrug
Also called 1,2,3, 4-Butanetetrol, 1,4-dimethanesulfonate, [R-(R*,S*)]-, Dihydroxybusulfan, Ovastat, Treosulphan
Intravenously administered Treosulfan
Laboratory Biomarker AnalysisOther
Correlative Studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Arm A: Treosulfan, Fludarabine Phosphate
Treosulfan intravenously (IV) over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2. Receives: Procedure: Allogeneic Bone Marrow Transplantation; Drug: Fludarabine Phosphate; Procedure: Peripheral Blood Stem Cell Transplantation; Radiation: Total-Body Irradiation; Drug: Treosulfan; Other: Laboratory Biomarker Analysis |
| Arm B | Experimental | Arm B: Treosulfan, Fludarabine Phosphate, TBI
Treosulfan and fludarabine phosphate as in Arm A and undergo low -dose total-body irradiation (TBI) on day 0 Receives: Procedure: Allogeneic Bone Marrow Transplantation; Drug: Fludarabine Phosphate; Procedure: Peripheral Blood Stem Cell Transplantation; Drug: Treosulfan; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Did Not Progress Within 6 Months
Progression is defined as relapse
Measured: At 6 months post-transplant
Secondary outcomes (7)
Number of Participants With Acute GVHD, Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Measured: Up to 84 days
Incidence of Chronic GVHD Graded by the NCI CTCAE Version 4.0
Measured: Up to 5 year
Incidence of Relapse/Progression
Measured: Up to 5 year
NRM
Measured: Up to 5 years
Overall Survival (OS)
Measured: Up to 2 year
Change in Gene Expression Profiles
Differences between arms in the changes in gene expression will be compared. 80% power to detect mean differences of approximately 1.4 standard deviation units, at the 2-sided 0.05 level of significance (with Bonferroni correction for 50 genes).
Measured: Baseline and at day 0 within 6 hours of conditioning prior to transplant
Relapse Risk as Measured by Degree of Change in Gene Expression Profiles
Among genes identified whose expression is modified by conditioning, degree of change in expression will be evaluated to determine if it is correlated with relapse risk and offers improved prediction of relapse risk over that obtained with standard clinical parameters (cytogenetics, blast count, International Prognostic Scoring System score, minimal residual disease. To account for censoring and the competing risk of non-relapse mortality (NRM), the analysis will be a time-to-event analysis of relapse using Cox regression, with change in expression as a continuous covariate (on a log scale). 8
Measured: Baseline and at day 0 within 6 hours of conditioning prior to transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startNov 2013
- Primary completion9 Jan 2017
- Study completionJun 2022 (estimated)
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 in RemissionStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Deeg, Fred Hutchinson Cancer Center
- Investigators
- H. Joachim Deeg, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894477
- Sponsor's protocol ID
- 2524.00
- Other IDs
- NCI-2013-01261, 2524, 2524.00, K12HL087165, P30CA015704
- Status last verified
- May 2021
- First submitted
- 1 Jul 2013
- Last updated
- 3 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Treosulfan, Fludarabine and Low-Dose TBI as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT01894477
- Acronym / sponsor ID
- 2524.00
- Conditions
- Acute Myeloid Leukemia in Remission, Chronic Myelomonocytic Leukemia, Minimal Residual Disease, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasm, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2013
- Primary completion
- 9 Jan 2017 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Posted 21 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well treosulfan and fludarabine phosphate, with or without total body irradiation before donor stem cell transplant works in treating patients with myelodysplastic syndrome or acute myeloid leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus before and mycophenolate mofetil after the transplant may stop this from happening.
Detailed description
PRIMARY OBJECTIVES:
- To determine the better of two treosulfan-based conditioning regimens in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), by comparing 6-month progression-free survival.
SECONDARY OBJECTIVES:
- Determine the effects of two conditioning regimens on changes in gene expression profiles, and evaluate the association of gene expression profiles and disease relapse.
II. Determine the incidence of progression-free survival at 1 year and 2 years after hematopoietic cell transplantation (HCT).
III. Evaluate overall survival (OS) at 6 months, at 1 year and at 2 years after HCT.
IV. Determine the incidence of grades II-IV acute graft-versus-host disease (GVHD).
- Determine the incidence of chronic GVHD.
VI. Determine donor chimerism around days +28 and +84.
CONDITIONING REGIMEN:
Arm A: Patients receive treosulfan intravenously (IV) over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
Arm B: Patients receive treosulfan and fludarabine phosphate as in Arm A and undergo low-dose total-body irradiation (TBI) on day 0.
TRANSPLANT: Patients in both arms undergo allogeneic peripheral blood stem cell (PBSC) transplant or bone marrow transplant on day 0.
GVHD PROPHYLAXIS: Patients with a related donor receive tacrolimus orally (PO) every 8 or 12 hours on days -3 to 56 with taper to day 180. Beginning 4-6 hours after PBSC infusion, patients also receive mycophenolate mofetil PO every 12 hours to day 28. Patients with an unrelated donor receive tacrolimus PO every 8 or 12 hours on days -3 to 100 with taper to day 180. Beginning 4-6 hours after PBSC infusion, patients also receive mycophenolate mofetil PO every 8 hours to day 40 with taper to day 96.
NOTE: Patients with related donors eligible for FHCRC protocol 2545 may receive cyclosporine IV, instead of tacrolimus, beginning on day -3 to day 50 with a taper to day 180.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Procedure: Allogeneic Bone Marrow Transplantation, Drug: Fludarabine Phosphate, Procedure: Peripheral Blood Stem Cell Transplantation, Radiation: Total-Body Irradiation, Drug: Treosulfan, Other: Laboratory Biomarker AnalysisArm A: Treosulfan, Fludarabine Phosphate Treosulfan intravenously (IV) over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2. |
| Arm B | Experimental | Procedure: Allogeneic Bone Marrow Transplantation, Drug: Fludarabine Phosphate, Procedure: Peripheral Blood Stem Cell Transplantation, Drug: Treosulfan, Other: Laboratory Biomarker AnalysisArm B: Treosulfan, Fludarabine Phosphate, TBI Treosulfan and fludarabine phosphate as in Arm A and undergo low -dose total-body irradiation (TBI) on day 0 |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- MDS, myelodysplastic syndrome/myeloproliferative neoplasia overlap disorders (including chronic myelomonocytic leukemia [CMML], and MDS/myeloproliferative neoplasm [MPN] unclassifiable syndromes)
- AML, other than acute promyelocytic leukemia (APL), in first or second remission or with minimal residual disease
- With Karnofsky index or Lansky Play-Performance scale > 70% on pre-transplant evaluation
- Able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)
- Patients with previous autologous or allogeneic HCT are allowed to enroll
Key exclusion criteria (20 listed)
- Receiving umbilical cord blood
- With impaired cardiac function as evidenced by ejection fraction < 35% (or, if unable to obtain ejection fraction, shortening fraction of < 26%) or cardiac insufficiency requiring treatment or symptomatic coronary artery disease; patients with a shortening fraction < 26% may be enrolled if approved by a cardiologist
- With impaired pulmonary function as evidenced by partial pressure of oxygen (pO2) < 70 mm Hg and carbon monoxide diffusing capability test (DLCO) < 70% of predicted or pO2 < 80 mm Hg and DLCO < 60% of predicted; (or, for pediatric patients unable to perform pulmonary function tests, then oxygen (O2) saturation < 92% on room air), or receiving supplementary continuous oxygen
- With impaired renal function as evidenced by creatinine-clearance < 50% for age, weight, height or serum creatinine > 2 x upper limit of normal or dialysis-dependent
- With hepatic dysfunction as evidenced by total bilirubin > 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
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 |
|---|---|---|
| Allogeneic Bone Marrow TransplantationAlso: Allo BMT, Allogeneic BMTUndergo allogeneic bone marrow transplant | Procedure or surgery | Arm A, Arm B |
| Fludarabine PhosphateAlso: 2-F-ara-AMP, Beneflur, Fludara, SH T 586Intravenously administered Fludarabine Phosphate | Drug | Arm A, Arm B |
| Peripheral Blood Stem Cell TransplantationAlso: PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell TransplantationUndergo allogeneic PBSC transplant | Procedure or surgery | Arm A, Arm B |
| Total-Body IrradiationAlso: TOTAL BODY IRRADIATION, Whole-Body IrradiationUndergo TBI | Radiation | Arm A |
| TreosulfanAlso: 1,2,3, 4-Butanetetrol, 1,4-dimethanesulfonate, [R-(R*,S*)]-, Dihydroxybusulfan, Ovastat, TreosulphanIntravenously administered Treosulfan | Drug | Arm A, Arm B |
| Laboratory Biomarker AnalysisCorrelative Studies | Other | Arm A, Arm B |
Primary outcome
Number of Participants That Did Not Progress Within 6 Months
Time frame: At 6 months post-transplant
Progression is defined as relapse
7 secondary outcomes
Number of Participants With Acute GVHD, Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: Up to 84 days
Incidence of Chronic GVHD Graded by the NCI CTCAE Version 4.0
Time frame: Up to 5 year
Incidence of Relapse/Progression
Time frame: Up to 5 year
NRM
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 2 year
Change in Gene Expression Profiles
Time frame: Baseline and at day 0 within 6 hours of conditioning prior to transplant
Relapse Risk as Measured by Degree of Change in Gene Expression Profiles
Time frame: Baseline and at day 0 within 6 hours of conditioning prior to transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 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.
H. Joachim Deeg principal investigator
Fred Hutch/University of Washington Cancer Consortium
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 Allogeneic Bone Marrow Transplantation, Fludarabine Phosphate and Peripheral Blood Stem Cell Transplantation in people with Acute Myeloid Leukemia in Remission and Chronic Myelomonocytic Leukemia, run by Fred Hutchinson Cancer Center 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 10 inclusion and 20 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 3 Jun 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 21 May 2018). 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?
Number of Participants That Did Not Progress Within 6 Months (time frame: At 6 months post-transplant). 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 3 Jun 2021.