Aplastic AnemiaPhase 2NCT00578903
Allogeneic Stem Cell Transplant for Patients With Severe Aplastic Anemia
A Phase 2 study testing Cytoxan, Campath and Total Body Irradiation (TBI) in people with Aplastic Anemia, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Patients have been diagnosed with severe Aplastic Anemia that have not responded to treatment with immunosuppressive therapy (drugs that suppress the immune system, for example Steroids). The immune system is the system in the body that helps protect the body and fights bacterial, viral and fungal infections. Read more about this study
- Who is it for?
- Ages 1 minute to 60 years
- Conditions the study is for
- Aplastic Anemia
- What is being tested?
- Cytoxan, Campath and Total Body Irradiation (TBI)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2002to Jul 2012
- 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 1 minute to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Severe Aplastic Anemia (SAA) based on bone marrow aspirate and biopsy results.
- Failure to respond to immunosuppressive therapy.
- Lack of an Human Leukocyte Antigen (HLA) identical family member.
- A 6/6 or 5/6 HLA matched unrelated donor or a 5/6 matched related donor available after high resolution HLA typing.
- Age from birth to 60 years.
Who cannot join
- Severe disease other than aplastic anemia that would limit the probability of survival during the graft procedure. Patients who present with active infection must be treated to maximally resolve this problem before beginning the conditioning regimen.
- Human immunodeficiency virus (HIV) seropositive patients
- Patients who have clonal cytogenetic abnormalities or a myelodysplastic syndrome.
- Patient greater than 60 years of age.
- Women who are pregnant or nursing.
- Patients with active hepatitis
Show all 9Show fewer
- Patients with severe cardiac dysfunction defined as shortening fraction < 25%.
- Patients with severe renal dysfunction defined as creatinine clearance < 40 ml/mim/1.73m2.
- Patient with severe pulmonary dysfunction with forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) 40% of predicted or 3 standard deviations (SD) below normal.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Children's Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
About this study
Official title: Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors (SAA MUD)
Patients have been diagnosed with severe Aplastic Anemia that have not responded to treatment with immunosuppressive therapy (drugs that suppress the immune system, for example Steroids). The immune system is the system in the body that helps protect the body and fights bacterial, viral and fungal infections.
Research studies have shown that patients with Aplastic Anemia have improved survival (may live longer) after receiving a HLA (Human Leukocyte Antigen) identical sibling (brother and sister) stem cell transplants. Patients who do not have matched siblings can undergo immunosuppressive therapy, which has also shown to improve outcome. Unfortunately patients who do not respond to immunosuppressive therapy usually die. The best chance of survival for these patients is an HLA matched unrelated or mismatched related stem cell transplant as described below.
Read more
Stem cells are created in the bone marrow. They mature into different types of blood cells that people need including red blood cells which carry oxygen around the body, white blood cells which help fight infections, and platelets which help the blood to clot and prevent bleeding. For a matched unrelated stem cell transplant, stem cells are collected from a person (donor) who is not related to the patient but who has the same type of stem cells. For a mismatched related stem cell transplant, stem cells are collected from a donor who is related to the patient and whose stem cells are almost the same as those of the patient but not exactly. The patient then receives high dose chemotherapy. This chemotherapy kills the stem cells in the patient's bone marrow. Stem cells that have been collected from the donor are then given to the patient to replace the stem cells that have been killed.
The major problems associated with these types of stem cell transplants are graft rejection (where the patient's immune system rejects the donor stem cells) and severe graft versus host disease (GVHD), where the donors stem cell reacts against the patient's tissues in the body.
Read the detailed description
Before patients receive any treatments, they will have the following:
- Complete history and physical exam
- Dental consultation
- Bone marrow aspirate
- Blood tests
- Urinanalysis
- Tests to look at your lungs (Chest X-ray and PFT's and DLCO)
- Tests to look at your heart (EKG, MUGA, or echocardiogram)
- Pregnancy test for females of childbearing age.
Once the decision has been made by the patients to have a mismatched related or matched unrelated stem cell transplant, the patient will receive treatment called a "conditioning regimen" to prepare their body for the transplant. The purpose of this conditioning regimen is to kill the stem cells in the bone marrow, so that the patients immune system is suppressed (lowered or stopped from working), so their body will not reject the donors stem cells (transplant).
The medicines which will be given as part of the conditioning regimen include Cyclophosphamide (Cytoxan) and Campath 1H. Both of these medications are approved by the Food and Drug Administration. Cyclophosphamide will be given for four days in a row. Cyclophosphamide is broken down into different chemicals and removed from the body in the urine. These different chemicals can cause bleeding in the bladder. Mesna is a drug that will be given with Cytoxan to prevent the build up of these chemicals that cause bleeding from the bladder. Campath 1H will also be given for four days. After the medicines, the patient will receive total body irradiation (TBI). Total body irradiation is strong doses of radiation (like x-rays) given to almost the whole body. One dose of TBI will be given to patients receiving a matched stem cell infusion while two doses of TBI will be given to patients receiving a mismatch stem cell infusion. After the conditioning regimen, the patient will then receive the stem cells (transplant). These stem cells will be given as an infusion (drip) into a vein.
Patients will receive the drugs Tacrolimus (FK506) and Methotrexate to help prevent the complication of graft versus host disease. Methotrexate will be given on days 1, 3, 6 and 11 after they receive the stem cells. During this time, the patient will be on the stem cell transplant unit in protective isolation to help protect from developing infections.
The following evaluations will be done as part of the stem cell transplant.
EVALUATION DURING THE FIRST 100 DAYS:
- Physical examination daily until discharged, then weekly.
- Peripheral Blood for chimerism studies (looks at the presence of cells from the donor and from the patient existing together after the transplant)
- Complete blood count (CBC) and platelets daily until discharge, then at least weekly
- Blood chemistry (Electrolytes, BUN, creatinine, glucose, calcium, uric acid, total protein, albumin, ALT, AST, LDH, total bilirubin, LDH, magnesium) checked daily until discharge, then at least weekly
- FK506 blood levels twice a week until discharge, then at least weekly
- Blood tests for CMV (a type of virus) weekly
DAY 100-365:
- Physical examination at least monthly through Day 365
- Peripheral blood for chimerism studies
- Follow-up for patients with chronic GVHD as needed
- Chest X-ray
- CBC and Blood chemistry tests as above checked monthly
YEARLY EVALUATION:
- Biopsies as needed (taking tissue samples for testing)
- Chest x-ray
- CBC and Blood chemistry evaluations as listed above
- Peripheral blood for chimerism studies
IMMUNOLOGIC TESTING:
We will also be looking at the patients immune function. To do this, we will take 30 ml (2 tablespoonfuls) of blood every two weeks for two months, then monthly for 6 months, and then every 3 months for 2 years. When possible, the blood that is taken will be taken through an existing IV line. However, at times drawing the blood will require another stick with a needle. These blood tests will be done for research purposes as part of this study. All other blood tests listed above are done as part of good clinical care for patients receiving a stem cell transplant.
- Conditions
- Aplastic Anemia
- Being tested
- Cytoxan, Campath, Total Body Irradiation (TBI), FK-506, Methotrexate
- Keywords
- Severe Aplastic Anemia, Severe
- Medical subject headings
- Anemia, Aplastic, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoxanDrug
Also called Cyclophosphamide
Cytoxan will be given at 50 mg/kg per dose for 4 successive days.
CampathDrug
Also called alemtuzumab
Campath will be given at a dose of 3 mg for patients whose weight is between 5 and 15 kg; at a dose of 5 mg for patients whose weight is between 16 and 30 kg; and at a dose of 10 mg for patients whose weight is greater than 30 kg. The last dose of Campath should be 24 hours or more before stem cell infusion.
Total Body Irradiation (TBI)Radiation
Also called Irradiation
TBI will be given at a dose of 200 cGy for 6/6 HLA match and at a dose of 400 cGy in two fractions of 200 cGy each for 5/6 HLA matched donor.
FK-506Drug
Also called Tacrolimus
FK-506 will be given at a dose of 0.03 mg/kg/day via continuous infusion over 24 hours from 4pm on day -2 until engraftment or when patient is able to take by mouth (PO), then 0.03 mg/kg PO every 12 hours.
MethotrexateDrug
Methotrexate will be administered on day +1, day +3, day +6 and day +11 at a dose of 5 mg/m2. The day +11 dose may be omitted at the discretion of the bone marrow transplant (BMT) in-patient attending physician.
Stem cell infusionProcedure or surgery
Where possible patients will receive bone marrow. Marrow will be collected as per National Marrow Donor Program (NMDP) guidelines to provide a volume of 15-20 ml/kg of marrow and/or 2-4 X 10^8 nucleated cells/kg. In case marrow cannot be collected, peripheral blood stem cell (PBSC) will be substituted. A minimum of 5-6 X 10^6 CD 34+ cells/kg should be collected, with a target of 10 X 10^6/kg.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
Cytoxan, Campath, TBI-Total Body Irradiation, FK-506, Methotrexate, Stem Cell Infusion Receives: Drug: Cytoxan; Drug: Campath; Radiation: Total Body Irradiation (TBI); Drug: FK-506; Drug: Methotrexate; Procedure: Stem cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Alive at 100 Days Post Transplant
Measured: 100 days
Secondary outcomes (5)
Number of Patients With Engraftment Rate at 100 Days Post Transplant
Absolute neutrophil count greater than 0.5 X 10^9/ml for at least 3 days
Measured: 100 days post transplant
Number of Patients With Acute GVHD at 100 Days Post Transplant
Measured: 100 days
Number of Patients With Chronic GVHD at 2 Years Post Transplant
Measured: 2 years
Number of Subjects Alive at 1 Year Post Transplant
Measured: 1 year
Number of Subjects Alive at 2 Years Post Transplant
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startFeb 2002
- Primary completionJul 2012
- Study completionJul 2012
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 Aplastic AnemiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Responsible party
- Principal investigator, Kathryn Leung, Baylor College of Medicine
- Investigators
- Kathryn Leung, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578903
- Sponsor's protocol ID
- 10915-SAA MUD
- Other IDs
- SAA MUD
- Status last verified
- Mar 2016
- First submitted
- 19 Dec 2007
- Last updated
- 22 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia, Using Matched Unrelated Donors and Mismatched Related Donors (SAA MUD)
- ClinicalTrials.gov ID
- NCT00578903
- Acronym / sponsor ID
- 10915-SAA MUD
- Conditions
- Aplastic Anemia
- Keywords
- Severe Aplastic Anemia, Severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Study start
- Feb 2002
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Posted 11 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients have been diagnosed with severe Aplastic Anemia that have not responded to treatment with immunosuppressive therapy (drugs that suppress the immune system, for example Steroids). The immune system is the system in the body that helps protect the body and fights bacterial, viral and fungal infections.
Research studies have shown that patients with Aplastic Anemia have improved survival (may live longer) after receiving a HLA (Human Leukocyte Antigen) identical sibling (brother and sister) stem cell transplants. Patients who do not have matched siblings can undergo immunosuppressive therapy, which has also shown to improve outcome. Unfortunately patients who do not respond to immunosuppressive therapy usually die. The best chance of survival for these patients is an HLA matched unrelated or mismatched related stem cell transplant as described below.
Stem cells are created in the bone marrow. They mature into different types of blood cells that people need including red blood cells which carry oxygen around the body, white blood cells which help fight infections, and platelets which help the blood to clot and prevent bleeding. For a matched unrelated stem cell transplant, stem cells are collected from a person (donor) who is not related to the patient but who has the same type of stem cells. For a mismatched related stem cell transplant, stem cells are collected from a donor who is related to the patient and whose stem cells are almost the same as those of the patient but not exactly. The patient then receives high dose chemotherapy. This chemotherapy kills the stem cells in the patient's bone marrow. Stem cells that have been collected from the donor are then given to the patient to replace the stem cells that have been killed.
The major problems associated with these types of stem cell transplants are graft rejection (where the patient's immune system rejects the donor stem cells) and severe graft versus host disease (GVHD), where the donors stem cell reacts against the patient's tissues in the body.
Detailed description
Before patients receive any treatments, they will have the following:
- Complete history and physical exam
- Dental consultation
- Bone marrow aspirate
- Blood tests
- Urinanalysis
- Tests to look at your lungs (Chest X-ray and PFT's and DLCO)
- Tests to look at your heart (EKG, MUGA, or echocardiogram)
- Pregnancy test for females of childbearing age.
Once the decision has been made by the patients to have a mismatched related or matched unrelated stem cell transplant, the patient will receive treatment called a "conditioning regimen" to prepare their body for the transplant. The purpose of this conditioning regimen is to kill the stem cells in the bone marrow, so that the patients immune system is suppressed (lowered or stopped from working), so their body will not reject the donors stem cells (transplant).
The medicines which will be given as part of the conditioning regimen include Cyclophosphamide (Cytoxan) and Campath 1H. Both of these medications are approved by the Food and Drug Administration. Cyclophosphamide will be given for four days in a row. Cyclophosphamide is broken down into different chemicals and removed from the body in the urine. These different chemicals can cause bleeding in the bladder. Mesna is a drug that will be given with Cytoxan to prevent the build up of these chemicals that cause bleeding from the bladder. Campath 1H will also be given for four days. After the medicines, the patient will receive total body irradiation (TBI). Total body irradiation is strong doses of radiation (like x-rays) given to almost the whole body. One dose of TBI will be given to patients receiving a matched stem cell infusion while two doses of TBI will be given to patients receiving a mismatch stem cell infusion. After the conditioning regimen, the patient will then receive the stem cells (transplant). These stem cells will be given as an infusion (drip) into a vein.
Patients will receive the drugs Tacrolimus (FK506) and Methotrexate to help prevent the complication of graft versus host disease. Methotrexate will be given on days 1, 3, 6 and 11 after they receive the stem cells. During this time, the patient will be on the stem cell transplant unit in protective isolation to help protect from developing infections.
The following evaluations will be done as part of the stem cell transplant.
EVALUATION DURING THE FIRST 100 DAYS:
- Physical examination daily until discharged, then weekly.
- Peripheral Blood for chimerism studies (looks at the presence of cells from the donor and from the patient existing together after the transplant)
- Complete blood count (CBC) and platelets daily until discharge, then at least weekly
- Blood chemistry (Electrolytes, BUN, creatinine, glucose, calcium, uric acid, total protein, albumin, ALT, AST, LDH, total bilirubin, LDH, magnesium) checked daily until discharge, then at least weekly
- FK506 blood levels twice a week until discharge, then at least weekly
- Blood tests for CMV (a type of virus) weekly
DAY 100-365:
- Physical examination at least monthly through Day 365
- Peripheral blood for chimerism studies
- Follow-up for patients with chronic GVHD as needed
- Chest X-ray
- CBC and Blood chemistry tests as above checked monthly
YEARLY EVALUATION:
- Biopsies as needed (taking tissue samples for testing)
- Chest x-ray
- CBC and Blood chemistry evaluations as listed above
- Peripheral blood for chimerism studies
IMMUNOLOGIC TESTING:
We will also be looking at the patients immune function. To do this, we will take 30 ml (2 tablespoonfuls) of blood every two weeks for two months, then monthly for 6 months, and then every 3 months for 2 years. When possible, the blood that is taken will be taken through an existing IV line. However, at times drawing the blood will require another stick with a needle. These blood tests will be done for research purposes as part of this study. All other blood tests listed above are done as part of good clinical care for patients receiving a stem cell transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Drug: Cytoxan, Drug: Campath, Radiation: Total Body Irradiation (TBI), Drug: FK-506, Drug: Methotrexate, Procedure: Stem cell infusionPatients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member. Cytoxan, Campath, TBI-Total Body Irradiation, FK-506, Methotrexate, Stem Cell Infusion |
Who may qualify
- Ages
- 1 minute to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of Severe Aplastic Anemia (SAA) based on bone marrow aspirate and biopsy results.
- Failure to respond to immunosuppressive therapy.
- Lack of an Human Leukocyte Antigen (HLA) identical family member.
- A 6/6 or 5/6 HLA matched unrelated donor or a 5/6 matched related donor available after high resolution HLA typing.
- Age from birth to 60 years.
Key exclusion criteria (9 listed)
- Severe disease other than aplastic anemia that would limit the probability of survival during the graft procedure. Patients who present with active infection must be treated to maximally resolve this problem before beginning the conditioning regimen.
- Human immunodeficiency virus (HIV) seropositive patients
- Patients who have clonal cytogenetic abnormalities or a myelodysplastic syndrome.
- Patient greater than 60 years of age.
- Women who are pregnant or nursing.
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 |
|---|---|---|
| CytoxanAlso: CyclophosphamideCytoxan will be given at 50 mg/kg per dose for 4 successive days. | Drug | Patients |
| CampathAlso: alemtuzumabCampath will be given at a dose of 3 mg for patients whose weight is between 5 and 15 kg; at a dose of 5 mg for patients whose weight is between 16 and 30 kg; and at a dose of 10 mg for patients whose weight is greater than 30 kg. The last dose of Campath should be 24 hours or more before stem cell infusion. | Drug | Patients |
| Total Body Irradiation (TBI)Also: IrradiationTBI will be given at a dose of 200 cGy for 6/6 HLA match and at a dose of 400 cGy in two fractions of 200 cGy each for 5/6 HLA matched donor. | Radiation | Patients |
| FK-506Also: TacrolimusFK-506 will be given at a dose of 0.03 mg/kg/day via continuous infusion over 24 hours from 4pm on day -2 until engraftment or when patient is able to take by mouth (PO), then 0.03 mg/kg PO every 12 hours. | Drug | Patients |
| MethotrexateMethotrexate will be administered on day +1, day +3, day +6 and day +11 at a dose of 5 mg/m2. The day +11 dose may be omitted at the discretion of the bone marrow transplant (BMT) in-patient attending physician. | Drug | Patients |
| Stem cell infusionWhere possible patients will receive bone marrow. Marrow will be collected as per National Marrow Donor Program (NMDP) guidelines to provide a volume of 15-20 ml/kg of marrow and/or 2-4 X 10^8 nucleated cells/kg. In case marrow cannot be collected, peripheral blood stem cell (PBSC) will be substituted. A minimum of 5-6 X 10^6 CD 34+ cells/kg should be collected, with a target of 10 X 10^6/kg. | Procedure or surgery | Patients |
Primary outcome
Number of Subjects Alive at 100 Days Post Transplant
Time frame: 100 days
5 secondary outcomes
Number of Patients With Engraftment Rate at 100 Days Post Transplant
Time frame: 100 days post transplant
Number of Patients With Acute GVHD at 100 Days Post Transplant
Time frame: 100 days
Number of Patients With Chronic GVHD at 2 Years Post Transplant
Time frame: 2 years
Number of Subjects Alive at 1 Year Post Transplant
Time frame: 1 year
Number of Subjects Alive at 2 Years Post Transplant
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- 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.
Kathryn Leung, MD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytoxan, Campath and Total Body Irradiation (TBI) in people with Aplastic Anemia, run by Baylor College of Medicine at 2 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 5 inclusion and 9 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 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 11 Oct 2013). 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 Subjects Alive at 100 Days Post Transplant (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 22 Apr 2016.