Myelodysplastic and Myeloproliferative DisordersPhase 1/2NCT00579111
Reduced Intensity Preparative Regimen Followed by Stem Cell Transplant (FAB)
A Phase 1/2 study testing Campath, Busulfan and Fludarabine in people with Myelodysplastic and Myeloproliferative Disorders and Acute Myelogenous Leukemia, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Blood disorders such as leukemia or lymphoma or hemoglobinopathies can benefit from receiving an allogeneic (meaning that the cells are from a donor) stem cell transplant. Stem cells are created in the bone marrow. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Myelodysplastic and Myeloproliferative Disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- Campath, Busulfan and Fludarabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2007to Oct 2010
- Phase
- Phase 1/2
- 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
- Diagnosis of myelodysplastic and myeloproliferative disorders, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, multiple myeloma, plasma cell dyscrasia, lymphoproliferative disorders (non-Hodgkin lymphoma, hairy cell leukemia, chronic lymphocytic leukemia, and Hodgkin's disease) and non malignant hematologic diseases considered treatable with an allogeneic transplant including but not limited to bone marrow failure syndrome, hemoglobinopathy and severe immunodeficiency states.
- Performance status 0-2 on Zubrod scale
- Ejection fraction > 30%
- AST/ALT and bilirubin not > 4 times normal
- FEV1 greater than 1.0 and diffusion capacity > 40%
- Age birth to 70 years of age
Show all 24Show fewer
- Conditions that increase treatment related mortality (need more than one to be eligible):
- Age > 35 years
- EF of less than 45%
- DLCO less than 50% or FEV1 50-75% of predicted value
- Diabetes mellitus
- Renal insufficiency, defined by increase in serum creatinine level of 1.5 times ULN or decrease in GFR by 25%
- Prior recent history of systemic fungal infection
- 3rd or greater remission of AML or ALL
- More than 1 year of diagnosis (CML or myeloma patients only)
- Multiple types of treatment regimens (equal to or more than 3)
- Prior autologous or allogeneic stem cell transplantation
- Significant Grade III or IV neurologic or hepatic toxicity as defined by NCI CTC toxicity from previous treatment
- No matched sibling donor
- Available healthy donor without any contraindications for donation
- 5/6 or 6/6 related
- 5/6 or 6/6 unrelated (molecular typing for DRB1)
- Patient and/or responsible person able to understand and sign consent
- For women of childbearing potential, negative pregnancy test
Who cannot join
- Pregnant and lactating women or women unwilling to use contraception.
- HIV positive patient.
- Uncontrolled intercurrent infection.
- Refractory AML or ALL.
- Untreated blast crisis for CML.
- Uncontrolled high-grade lymphoproliferative disease/lymphoma.
Show all 13Show fewer
- Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater).
- Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater).
- Hemodialysis dependent.
- Active Hepatitis or cirrhosis with total bilirubin, SGOT, and SGPT greater than 3 x normal.
- Serum creatinine >2x ULN.
- Unstable cerebral vascular disease and recent hemorrhagic stroke (less than 6 months).
- Active CNS disease from hematological disorder.
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: Reduced-Intensity Preparative Regiment With Fludarabine, Busulfan, And Alemtuzumab (Campath 1H) Followed By Allogeneic Hematopoietic Stem Cell Transplant For Malignant And Non-Malignant Hematological Diseases
Blood disorders such as leukemia or lymphoma or hemoglobinopathies can benefit from receiving an allogeneic (meaning that the cells are from a donor) stem cell transplant. Stem cells are created in the bone marrow. They grow into different types of blood cells that the body needs, including red blood cells, white blood cells, and platelets. In a transplant, the body's stem cells would be killed and then replaced by stem cells from the donor. Usually, patients are given very high doses of chemotherapy (drugs which kill cancer cells) prior to receiving a stem cell transplant. However, patients that are older, have received several prior treatments, or have other organ diseases are at a high risk of getting life-threatening treatment-related side effects from high doses of chemotherapy. Over the past several years, some doctors have begun to use lower doses of chemotherapy for preparing patients for a stem cell transplant.
A condition that can occur after a stem cell transplant from a donor is Graft Versus Host Disease (GVHD). It is a rare but serious disorder that can strike persons whose immune system is suppressed and have received either a blood transfusion or a bone marrow transplant. Symptoms may include skin rash, intestinal problems similar to inflammation of the bowel and liver dysfunction.
Read more
This research study uses a combination of lower-dose chemotherapy agents that is slightly different from those that have been used before.
The medicines that will be used in this study are Fludarabine, Busulfan, both chemotherapy medicines, and Campath. Campath is a monoclonal antibody (a type of substance produced in the laboratory that binds to cancer cells). It helps the immune system see the cancer cell as something that needs to be destroyed.
This research study will help us learn if using Fludarabine, Busulfan and Campath prior to an allogeneic stem cell transplant can provide treatment for blood disorders while decreasing the incidence of side effects.
Read the detailed description
Allogeneic stem cell transplantation with high-dose chemotherapy affords a better chance of cure of malignant and non-malignant hematological diseases compared to autologous transplantation, because of the lack of stem cell contamination and the immune mediated graft vs. leukemia effect. Unfortunately, high-dose chemotherapy and allogeneic stem cell transplantation has a substantial treatment related mortality, that is particularly high in older patients (greater than 50 yrs of age), or in those with co-morbidities such as congestive heart disease and pulmonary disease. Patients who have pre-existing infections or who have had multiple relapses with prior chemotherapy are also at high risk. In all these groups, treatment related mortality may exceed 50%, making them ineligible for high-dose chemotherapy and allogeneic stem cell transplantation.
Recently interest has increased in using less toxic chemotherapy protocols that are termed submyeloablative. The intent is to allow partial engraftment of a donor immune and hemopoietic systems with subsequent progressive replacement of the host's own hemopoiesis and immunity. As the donor immune system becomes established, patients may develop full donor chimerism, without passing through the period of prolonged aplasia associated with conventional conditioning regimens, and with less of the associated toxicity. Preliminary results in high-risk patients have shown treatment related mortality (TRM) of 15-20%, versus 50% expected, with an overall survival rate of 70-80% at 1-2 years post transplant.
As might be anticipated, the major problem with sub-ablative conditioning is that the graft failure rate is increased, with published figures of 5-30% versus 1-5% predicted in fully ablated patients. The incorporation of lymphodepleting antibodies in the preliminary conditioning regimen may allow these rejection rates to be diminished. Moreover, a highly efficient lymphodepleting MAb or MAb combination might be successfully substituted in part or in whole for cytotoxic and immunosuppressive drugs, further increasing the safety and efficacy of the subablative approach to stem cell transplantation. Our own data using the crude polyclonal mixture of antibodies in ATG as a component of pre-transplant conditioning revealed an improvement in engraftment during matched unrelated donor transplantation.The lymphodepleting monoclonal antibody Campath IH has many of the properties desired for this application, and we propose to incorporate it in our conditioning regimen. Since CAMPATH1H persists after infusion, we would expect it to have additional anti-GvHD effector function, further reducing treatment related mortality (TRM).
The following preparative regimen will be delivered to all patients:
- Busulfan 3.2 mg/kg/day IV daily for 2 days, infused over 3 hours, on Day -5 and Day -4
- Fludarabine 30mg/m2/day IV daily for 4 days on Day -5 to D -2
- Campath 10 mg/day IV daily for 3 days on days -6 to D-4.
Because CAMPATH-1H infusions will provide a persisting level of antibody over the transplant period, it will contribute to anti-GvHD activity. Additional Graft vs. host disease prophylaxis will consist of FK506 administered from Day-2.
The stem cells will be infused on day 0.
- Conditions
- Myelodysplastic and Myeloproliferative Disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia
- Being tested
- Campath, Busulfan, Fludarabine, Hematopoietic stem cell infusion, FK-506
- Keywords
- Myelodysplastic and Myeloproliferative Disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Multiple Myeloma, Plasma Cell dyscrasia, Lymphoproliferative disorders, Hematologic Diseases, Fludarabine, Busulfan, Campath, Alemtuzumab, allogeneic stem cell transplant
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Multiple Myeloma, Paraproteinemias, Lymphoproliferative Disorders, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CampathDrug
Also called Alemtuzumab
10 mg/day IV daily for 3 days on days -6 to D-4. Campath may be omitted from the conditioning regimen for patients with malignant diseases and matched related donor transplants
BusulfanDrug
3.2 mg/kg/day IV daily for 2 days, infused over 3 hours, on Day -5 and Day -4
FludarabineDrug
30mg/m2/day IV daily for 4 days on Day -5 to D -2
Hematopoietic stem cell infusionProcedure or surgery
Peripheral blood stem cells when possible. Bone marrow cells will be used if peripheral blood cells are insufficient or unavailable.
FK-506Drug
Also called Tacrolimus
FK-506 at a dose of 0.03 mg/kd/day will be administered via continuous infusion over 24 hours from 4pm on Day -2 until engraftment or when the patient is able to take PO, then 0.03 mg/kg PO every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| HLA-identical sibling transplant | Experimental | Recipients of HLA identical sibling stem cell transplants Receives: Drug: Campath; Drug: Busulfan; Drug: Fludarabine; Procedure: Hematopoietic stem cell infusion; Drug: FK-506 |
| Unrelated Matched or Single Antigen Mismatched transplant | Experimental | Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants Receives: Drug: Campath; Drug: Busulfan; Drug: Fludarabine; Procedure: Hematopoietic stem cell infusion; Drug: FK-506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Successful Donor Engraftment
Each patient will be classified as a success or failure. A success will be defined as engraftment of at least 35% of cells 100 days after transplant.
Measured: 100 days
Secondary outcomes (1)
Number of Patients With Treatment Related Grade III or IV Non-hematological Toxicity
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startJun 2007
- Primary completionFeb 2009
- Study completionOct 2010
Why it stopped: slow accrual
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 Myelodysplastic and Myeloproliferative DisordersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Rammurti Kamble, Baylor College of Medicine
- Investigators
- Rammurti T Kamble, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579111
- Sponsor's protocol ID
- 19386
- Other IDs
- FAB
- Status last verified
- Mar 2016
- First submitted
- 19 Dec 2007
- Last updated
- 4 May 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 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced-Intensity Preparative Regiment With Fludarabine, Busulfan, And Alemtuzumab (Campath 1H) Followed By Allogeneic Hematopoietic Stem Cell Transplant For Malignant And Non-Malignant Hematological Diseases
- ClinicalTrials.gov ID
- NCT00579111
- Acronym / sponsor ID
- 19386
- Conditions
- Myelodysplastic and Myeloproliferative Disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Multiple Myeloma, Plasma Cell Dyscrasia
- Keywords
- Myelodysplastic and Myeloproliferative Disorders, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Multiple Myeloma, Plasma Cell dyscrasia, Lymphoproliferative disorders, Hematologic Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Posted 9 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blood disorders such as leukemia or lymphoma or hemoglobinopathies can benefit from receiving an allogeneic (meaning that the cells are from a donor) stem cell transplant. Stem cells are created in the bone marrow. They grow into different types of blood cells that the body needs, including red blood cells, white blood cells, and platelets. In a transplant, the body's stem cells would be killed and then replaced by stem cells from the donor. Usually, patients are given very high doses of chemotherapy (drugs which kill cancer cells) prior to receiving a stem cell transplant. However, patients that are older, have received several prior treatments, or have other organ diseases are at a high risk of getting life-threatening treatment-related side effects from high doses of chemotherapy. Over the past several years, some doctors have begun to use lower doses of chemotherapy for preparing patients for a stem cell transplant.
A condition that can occur after a stem cell transplant from a donor is Graft Versus Host Disease (GVHD). It is a rare but serious disorder that can strike persons whose immune system is suppressed and have received either a blood transfusion or a bone marrow transplant. Symptoms may include skin rash, intestinal problems similar to inflammation of the bowel and liver dysfunction.
This research study uses a combination of lower-dose chemotherapy agents that is slightly different from those that have been used before.
The medicines that will be used in this study are Fludarabine, Busulfan, both chemotherapy medicines, and Campath. Campath is a monoclonal antibody (a type of substance produced in the laboratory that binds to cancer cells). It helps the immune system see the cancer cell as something that needs to be destroyed.
This research study will help us learn if using Fludarabine, Busulfan and Campath prior to an allogeneic stem cell transplant can provide treatment for blood disorders while decreasing the incidence of side effects.
Detailed description
Allogeneic stem cell transplantation with high-dose chemotherapy affords a better chance of cure of malignant and non-malignant hematological diseases compared to autologous transplantation, because of the lack of stem cell contamination and the immune mediated graft vs. leukemia effect. Unfortunately, high-dose chemotherapy and allogeneic stem cell transplantation has a substantial treatment related mortality, that is particularly high in older patients (greater than 50 yrs of age), or in those with co-morbidities such as congestive heart disease and pulmonary disease. Patients who have pre-existing infections or who have had multiple relapses with prior chemotherapy are also at high risk. In all these groups, treatment related mortality may exceed 50%, making them ineligible for high-dose chemotherapy and allogeneic stem cell transplantation.
Recently interest has increased in using less toxic chemotherapy protocols that are termed submyeloablative. The intent is to allow partial engraftment of a donor immune and hemopoietic systems with subsequent progressive replacement of the host's own hemopoiesis and immunity. As the donor immune system becomes established, patients may develop full donor chimerism, without passing through the period of prolonged aplasia associated with conventional conditioning regimens, and with less of the associated toxicity. Preliminary results in high-risk patients have shown treatment related mortality (TRM) of 15-20%, versus 50% expected, with an overall survival rate of 70-80% at 1-2 years post transplant.
As might be anticipated, the major problem with sub-ablative conditioning is that the graft failure rate is increased, with published figures of 5-30% versus 1-5% predicted in fully ablated patients. The incorporation of lymphodepleting antibodies in the preliminary conditioning regimen may allow these rejection rates to be diminished. Moreover, a highly efficient lymphodepleting MAb or MAb combination might be successfully substituted in part or in whole for cytotoxic and immunosuppressive drugs, further increasing the safety and efficacy of the subablative approach to stem cell transplantation. Our own data using the crude polyclonal mixture of antibodies in ATG as a component of pre-transplant conditioning revealed an improvement in engraftment during matched unrelated donor transplantation.The lymphodepleting monoclonal antibody Campath IH has many of the properties desired for this application, and we propose to incorporate it in our conditioning regimen. Since CAMPATH1H persists after infusion, we would expect it to have additional anti-GvHD effector function, further reducing treatment related mortality (TRM).
The following preparative regimen will be delivered to all patients:
- Busulfan 3.2 mg/kg/day IV daily for 2 days, infused over 3 hours, on Day -5 and Day -4
- Fludarabine 30mg/m2/day IV daily for 4 days on Day -5 to D -2
- Campath 10 mg/day IV daily for 3 days on days -6 to D-4.
Because CAMPATH-1H infusions will provide a persisting level of antibody over the transplant period, it will contribute to anti-GvHD activity. Additional Graft vs. host disease prophylaxis will consist of FK506 administered from Day-2.
The stem cells will be infused on day 0.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLA-identical sibling transplant | Experimental | Drug: Campath, Drug: Busulfan, Drug: Fludarabine, Procedure: Hematopoietic stem cell infusion, Drug: FK-506Recipients of HLA identical sibling stem cell transplants |
| Unrelated Matched or Single Antigen Mismatched transplant | Experimental | Drug: Campath, Drug: Busulfan, Drug: Fludarabine, Procedure: Hematopoietic stem cell infusion, Drug: FK-506Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (24 listed)
- Diagnosis of myelodysplastic and myeloproliferative disorders, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, multiple myeloma, plasma cell dyscrasia, lymphoproliferative disorders (non-Hodgkin lymphoma, hairy cell leukemia, chronic lymphocytic leukemia, and Hodgkin's disease) and non malignant hematologic diseases considered treatable with an allogeneic transplant including but not limited to bone marrow failure syndrome, hemoglobinopathy and severe immunodeficiency states.
- Performance status 0-2 on Zubrod scale
- Ejection fraction > 30%
- AST/ALT and bilirubin not > 4 times normal
- FEV1 greater than 1.0 and diffusion capacity > 40%
Key exclusion criteria (13 listed)
- Pregnant and lactating women or women unwilling to use contraception.
- HIV positive patient.
- Uncontrolled intercurrent infection.
- Refractory AML or ALL.
- Untreated blast crisis for CML.
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 |
|---|---|---|
| CampathAlso: Alemtuzumab10 mg/day IV daily for 3 days on days -6 to D-4. Campath may be omitted from the conditioning regimen for patients with malignant diseases and matched related donor transplants | Drug | HLA-identical sibling transplant, Unrelated Matched or Single Antigen Mismatched transplant |
| Busulfan3.2 mg/kg/day IV daily for 2 days, infused over 3 hours, on Day -5 and Day -4 | Drug | HLA-identical sibling transplant, Unrelated Matched or Single Antigen Mismatched transplant |
| Fludarabine30mg/m2/day IV daily for 4 days on Day -5 to D -2 | Drug | HLA-identical sibling transplant, Unrelated Matched or Single Antigen Mismatched transplant |
| Hematopoietic stem cell infusionPeripheral blood stem cells when possible. Bone marrow cells will be used if peripheral blood cells are insufficient or unavailable. | Procedure or surgery | HLA-identical sibling transplant, Unrelated Matched or Single Antigen Mismatched transplant |
| FK-506Also: TacrolimusFK-506 at a dose of 0.03 mg/kd/day will be administered via continuous infusion over 24 hours from 4pm on Day -2 until engraftment or when the patient is able to take PO, then 0.03 mg/kg PO every 12 hours. | Drug | HLA-identical sibling transplant, Unrelated Matched or Single Antigen Mismatched transplant |
Primary outcome
Number of Patients With Successful Donor Engraftment
Time frame: 100 days
Each patient will be classified as a success or failure. A success will be defined as engraftment of at least 35% of cells 100 days after transplant.
1 secondary outcome
Number of Patients With Treatment Related Grade III or IV Non-hematological Toxicity
Time frame: 100 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 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.
Rammurti T Kamble, 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 1/2 study testing Campath, Busulfan and Fludarabine in people with Myelodysplastic and Myeloproliferative Disorders and Acute Myelogenous Leukemia, 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 24 inclusion and 13 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 4 May 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 combined 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.
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 9 Aug 2012). 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 Patients With Successful Donor Engraftment (time frame: 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.