Accelerated Phase Chronic Myelogenous LeukemiaPhase 2NCT01044745
Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer
A Phase 2 study testing rituximab, mycophenolate mofetil and tacrolimus in people with Accelerated Phase Chronic Myelogenous Leukemia and Adult Acute Lymphoblastic Leukemia in Remission, run by University of Nebraska at 1 site in United States.
Trial summary
This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission
- What is being tested?
- rituximab, mycophenolate mofetil and tacrolimus
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2009to 10 Oct 2017
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML) in accelerated phase or blast crisis, chronic lymphocytic leukemia (CLL), Non-Hodgkin lymphoma (NHL), myelodysplastic syndromes (MDS) (intermediate-2 or high-risk disease by International Pelvic Pain Society [IPPS])
- Patients with AML, ALL, or MDS scheduled for myeloablative conditioning should have =< 10% blasts in bone marrow or peripheral blood at the start of conditioning
- Patients with AML, ALL, or CML scheduled for reduced intensity conditioning or non-myeloablative conditioning should be in complete morphologic remission at the start of conditioning (residual disease by flow cytometry or cytogenetics and/or incomplete recovery of neutrophil or platelet count are acceptable)
- Patients with CLL or NHL scheduled for reduced intensity or non-myeloablative conditioning should have no evidence of bulky disease (> 50% bone marrow involvement or masses > 10 cm) at the start of conditioning
- Fulfills all pulmonary, cardiac, renal, and hepatic criteria for standard-of-care matched unrelated donor (MUD) allogeneic HCT
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after stem cell transplantation
- Adequately matched unrelated donor available
- Written informed consent; written informed consent of the unrelated donor is required to participate in the optional studies
Who cannot join
- Patient or donor infected with human immunodeficiency virus (HIV)
- Patient or donor with history of hepatitis B or C and/or positive serology consistent with previous hepatitis B or C infection (patients and/or donor who received Hepatitis B vaccination are acceptable)
- Patient or donor with active hepatitis B or C and/or detectable viral ribonucleic acid (RNA)
- More than 20,000 circulating CD20+ cells/uL
- Treatment with rituximab for any reason in the 12 months preceding HCT
- Patient scheduled for cord blood transplantation
Show all 11Show fewer
- Presence of active uncontrolled infection at start of conditioning
- Presence of active central nervous system (CNS) disease (history of adequately treated CNS disease is acceptable)
- Presence of uncontrolled psychiatric disorder
- Patient unable to give informed consent
- Unrelated donor products received from the Deutsche Knochenmarkspenderdatei (DKMS) Registry are not eligible for the optional study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Rituximab For Prevention Of Acute Graft-Versus-Host Disease (GVHD) After Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (HCT)
This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy 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 a monoclonal antibody, rituximab, together with anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the transplant may stop this from happening
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the incidence of grade II-IV acute GVHD at day 100 after matched unrelated donor allogeneic hematopoietic cell transplantation (HCT) when incorporating rituximab in the conditioning regimen.
SECONDARY OBJECTIVES:
- To determine the day 100 transplant related mortality after matched unrelated donor allogeneic HCT when incorporating rituximab in the conditioning regimen.
II. To determine overall survival (OS) and disease-free survival (DFS) after matched unrelated donor allogeneic HCT when incorporating rituximab in the conditioning regimen.
III. To determine the cumulative incidence of infectious complications at day 100 after matched unrelated donor HCT when incorporating rituximab in the conditioning regimen.
IV. To determine the effect of rituximab addition to the conditioning regimen on recovery of T regulatory (T-reg) cells, and to determine the effect of T-cell, including T-reg, number in the stem cell product and at day 30 on the incidence of grade II-IV acute GVHD (aGVHD) and the cumulative infectious complications at day 100.
- To determine the effect of rituximab addition to the conditioning regimen on antigen presenting myeloid cell recovery, and to determine the effect of dendritic cell subset DC1, DC2 and myeloid-derived suppressor cells (MDSC), number in the stem cell graft and at day +30 on the incidence of acute GVHD grade II-IV and the cumulative incidence of infectious complications at day 100.
OUTLINE:
CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and total-body irradiation (TBI); targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab intravenously (IV) on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then orally (PO) beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Patients are followed up periodically for 100 days after transplant.
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Blastic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Burkitt Lymphoma
- Being tested
- rituximab, mycophenolate mofetil, tacrolimus, anti-thymocyte globulin, allogeneic hematopoietic stem cell transplantation
- Medical subject headings
- Leukemia, Myeloid, Accelerated Phase, Lymphoma, Extranodal NK-T-Cell, Blast Crisis, Graft vs Host Disease, Lymphoma, B-Cell, Marginal Zone, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
Also called IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8
Given IV
Also called Cellcept, MMF
Given IV or PO
tacrolimusDrug
Also called FK 506, Prograf
Given IV
anti-thymocyte globulinDrug
Also called ATG, ATGAM, lymphocyte immune globulin, Thymoglobulin
Given IV
allogeneic hematopoietic stem cell transplantationProcedure or surgery
Stem cell transplant
laboratory biomarker analysisOther
Correlative studies
graft versus host disease prophylaxis/therapyBiological
Also called prophylaxis/therapy, graft versus host disease, prophylaxis/therapy, GVHD
Undergo graft versus host disease prophylaxis/therapy
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
Given PO or IV
Also called 2-F-ara-AMP, Beneflur, Fludara
Given IV
busulfanDrug
Also called BSF, BU, Misulfan, Mitosan
Given IV
total-body irradiationRadiation
Also called TBI
Undergo TBI
graft-versus-tumor induction therapyBiological
Also called graft versus host disease induction, graft versus tumor induction
Undergo graft-versus-tumor induction therapy
immunosuppressive therapyBiological
Also called immunosuppression
Undergo immunosuppressive therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Rituximab and allogeneic HCT transplant) | Experimental | CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab IV on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. Receives: Drug: rituximab; Drug: mycophenolate mofetil; Drug: tacrolimus; Drug: anti-thymocyte globulin; Procedure: allogeneic hematopoietic stem cell transplantation; Other: laboratory biomarker analysis; Biological: graft versus host disease prophylaxis/therapy; Drug: cyclophosphamide; Drug: fludarabine phosphate; Drug: busulfan; Radiation: total-body irradiation; Biological: graft-versus-tumor induction therapy; Biological: immunosuppressive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grades II-IV Acute GVHD
Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
Measured: At day 100
Secondary outcomes (3)
Event-free Survival
Estimated using Kaplan-Meier estimator.
Measured: From the date of transplant with relapse/progression or death as censored events, up to 2 years
Overall Survival
Estimated using Kaplan-Meier estimator.
Measured: From the date of transplant with death from any cause as a censored event, up to 2 years
Transplant-related Mortality (TRM)
Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage.
Measured: At day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study start10 Dec 2009
- Primary completion19 Dec 2012
- Study completion10 Oct 2017
Why it stopped: Study was closed to accrual for safety related to the frequency of BK infections.
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 Accelerated Phase Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert Bociek, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044745
- Sponsor's protocol ID
- 0083-09-FB
- Other IDs
- NCI-2009-01552, P30CA036727
- Status last verified
- Aug 2023
- First submitted
- 7 Jan 2010
- Last updated
- 6 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab For Prevention Of Acute Graft-Versus-Host Disease (GVHD) After Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (HCT)
- ClinicalTrials.gov ID
- NCT01044745
- Acronym / sponsor ID
- 0083-09-FB
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Blastic Phase Chronic Myelogenous Leukemia, Contiguous Stage II Adult Burkitt Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was closed to accrual for safety related to the frequency of BK infections.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Dec 2009 (actual)
- Primary completion
- 19 Dec 2012 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Posted 26 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy 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 a monoclonal antibody, rituximab, together with anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the transplant may stop this from happening
Detailed description
PRIMARY OBJECTIVES:
- To determine the incidence of grade II-IV acute GVHD at day 100 after matched unrelated donor allogeneic hematopoietic cell transplantation (HCT) when incorporating rituximab in the conditioning regimen.
SECONDARY OBJECTIVES:
- To determine the day 100 transplant related mortality after matched unrelated donor allogeneic HCT when incorporating rituximab in the conditioning regimen.
II. To determine overall survival (OS) and disease-free survival (DFS) after matched unrelated donor allogeneic HCT when incorporating rituximab in the conditioning regimen.
III. To determine the cumulative incidence of infectious complications at day 100 after matched unrelated donor HCT when incorporating rituximab in the conditioning regimen.
IV. To determine the effect of rituximab addition to the conditioning regimen on recovery of T regulatory (T-reg) cells, and to determine the effect of T-cell, including T-reg, number in the stem cell product and at day 30 on the incidence of grade II-IV acute GVHD (aGVHD) and the cumulative infectious complications at day 100.
- To determine the effect of rituximab addition to the conditioning regimen on antigen presenting myeloid cell recovery, and to determine the effect of dendritic cell subset DC1, DC2 and myeloid-derived suppressor cells (MDSC), number in the stem cell graft and at day +30 on the incidence of acute GVHD grade II-IV and the cumulative incidence of infectious complications at day 100.
OUTLINE:
CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and total-body irradiation (TBI); targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI.
GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab intravenously (IV) on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then orally (PO) beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60.
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.
Patients are followed up periodically for 100 days after transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (Rituximab and allogeneic HCT transplant) | Experimental | Drug: rituximab, Drug: mycophenolate mofetil, Drug: tacrolimus, Drug: anti-thymocyte globulin, Procedure: allogeneic hematopoietic stem cell transplantation, Other: laboratory biomarker analysis, Biological: graft versus host disease prophylaxis/therapy, Drug: cyclophosphamide, Drug: fludarabine phosphate, Drug: busulfan, Radiation: total-body irradiation, Biological: graft-versus-tumor induction therapy, Biological: immunosuppressive therapyCONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab IV on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML) in accelerated phase or blast crisis, chronic lymphocytic leukemia (CLL), Non-Hodgkin lymphoma (NHL), myelodysplastic syndromes (MDS) (intermediate-2 or high-risk disease by International Pelvic Pain Society [IPPS])
- Patients with AML, ALL, or MDS scheduled for myeloablative conditioning should have =< 10% blasts in bone marrow or peripheral blood at the start of conditioning
- Patients with AML, ALL, or CML scheduled for reduced intensity conditioning or non-myeloablative conditioning should be in complete morphologic remission at the start of conditioning (residual disease by flow cytometry or cytogenetics and/or incomplete recovery of neutrophil or platelet count are acceptable)
- Patients with CLL or NHL scheduled for reduced intensity or non-myeloablative conditioning should have no evidence of bulky disease (> 50% bone marrow involvement or masses > 10 cm) at the start of conditioning
- Fulfills all pulmonary, cardiac, renal, and hepatic criteria for standard-of-care matched unrelated donor (MUD) allogeneic HCT
Key exclusion criteria (11 listed)
- Patient or donor infected with human immunodeficiency virus (HIV)
- Patient or donor with history of hepatitis B or C and/or positive serology consistent with previous hepatitis B or C infection (patients and/or donor who received Hepatitis B vaccination are acceptable)
- Patient or donor with active hepatitis B or C and/or detectable viral ribonucleic acid (RNA)
- More than 20,000 circulating CD20+ cells/uL
- Treatment with rituximab for any reason in the 12 months preceding HCT
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 |
|---|---|---|
| rituximabAlso: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8Given IV | Drug | Treatment (Rituximab and allogeneic HCT transplant) |
| mycophenolate mofetilAlso: Cellcept, MMFGiven IV or PO | Drug | Treatment (Rituximab and allogeneic HCT transplant) |
| tacrolimusAlso: FK 506, PrografGiven IV | Drug | Treatment (Rituximab and allogeneic HCT transplant) |
| anti-thymocyte globulinAlso: ATG, ATGAM, lymphocyte immune globulin, ThymoglobulinGiven IV | Drug | Treatment (Rituximab and allogeneic HCT transplant) |
| allogeneic hematopoietic stem cell transplantationStem cell transplant | Procedure or surgery | Treatment (Rituximab and allogeneic HCT transplant) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (Rituximab and allogeneic HCT transplant) |
| graft versus host disease prophylaxis/therapyAlso: prophylaxis/therapy, graft versus host disease, prophylaxis/therapy, GVHDUndergo graft versus host disease prophylaxis/therapy | Biological | Treatment (Rituximab and allogeneic HCT transplant) |
| cyclophosphamideAlso: CPM, CTX, Cytoxan, EndoxanGiven PO or IV | Drug | Treatment (Rituximab and allogeneic HCT transplant) |
| fludarabine phosphateAlso: 2-F-ara-AMP, Beneflur, FludaraGiven IV | Drug | Treatment (Rituximab and allogeneic HCT transplant) |
| busulfanAlso: BSF, BU, Misulfan, MitosanGiven IV | Drug | Treatment (Rituximab and allogeneic HCT transplant) |
| total-body irradiationAlso: TBIUndergo TBI | Radiation | Treatment (Rituximab and allogeneic HCT transplant) |
| graft-versus-tumor induction therapyAlso: graft versus host disease induction, graft versus tumor inductionUndergo graft-versus-tumor induction therapy | Biological | Treatment (Rituximab and allogeneic HCT transplant) |
| immunosuppressive therapyAlso: immunosuppressionUndergo immunosuppressive therapy | Biological | Treatment (Rituximab and allogeneic HCT transplant) |
Primary outcome
Number of Participants With Grades II-IV Acute GVHD
Time frame: At day 100
Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
3 secondary outcomes
Event-free Survival
Time frame: From the date of transplant with relapse/progression or death as censored events, up to 2 years
Overall Survival
Time frame: From the date of transplant with death from any cause as a censored event, up to 2 years
Transplant-related Mortality (TRM)
Time frame: At day 100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- 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.
Robert Bociek, MD principal investigator
University of Nebraska
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 rituximab, mycophenolate mofetil and tacrolimus in people with Accelerated Phase Chronic Myelogenous Leukemia and Adult Acute Lymphoblastic Leukemia in Remission, run by University of Nebraska 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 8 inclusion and 11 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 6 Sep 2023. 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 26 Feb 2019). 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 With Grades II-IV Acute GVHD (time frame: At day 100). 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 6 Sep 2023.