LeukemiaPhase 1NCT00473551
Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Indolent Lymphoid Malignancies
A Phase 1 study testing Rituximab, Cyclophosphamide and Fludarabine in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes, defined as the dose which achieve engraftment without severe GVHD (graft-vs-host disease) at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells. Secondary Objective: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Rituximab, Cyclophosphamide and Fludarabine
- 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
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70
- Confirmed diagnosis of follicular lymphoma, mantle cell lymphoma, chronic lymphocyte leukemia/small lymphocytic lymphoma or multiple myeloma. Patients must have had persistent or progressive disease despite initial chemotherapy. Patients must have achieved a partial or complete response to their most recent chemotherapy.
- Patients must have an human leukocyte antigen (HLA) matched (HLA-A, B, C DR or DQ) related donor who is seropositive against Epstein Barr virus and capable of donating peripheral blood mononuclear cells and peripheral blood progenitor cells.
- Patient must be HLA completely mismatched for HLA class I loci (A, B and C) with the 3rd party stimulator cells. HLA-A (330301, 310102) HLA-B (5801,150101[62]) HLA-C (0302, 030301)
- Zubrod Performance Scale (PS) of 0 or 1
- Creatinine < 1.8 mg/dl
Show all 9Show fewer
- Ejection fraction >/=40%
- Corrected Carbon Monoxide Diffusing Capacity (DLCO) >/=45% predicted
- Serum bilirubin </=1.5 mg/dl if not due to Gilbert's syndrome
Who cannot join
- Uncontrolled infection
- HIV, hepatitis B surface antigen or hepatitis C seropositive
- serum glutamic-pyruvic transaminase (SGPT) > 200 IU/ml
- Pregnant or lactating women i.e., positive Beta human chorionic gonadotrophin (hCG) test in a woman with child bearing potential. Child bearing potential is defined as not post-menopausal for 12 months or no previous surgical sterilization.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Treatment of Indolent Lymphoid Malignancies
Primary Objective:
- To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes, defined as the dose which achieve engraftment without severe GVHD (graft-vs-host disease) at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells.
Secondary Objective:
- Toxicity, response rate, time to progression and overall survival.
Read the detailed description
GVHD can be a major problem after stem cell transplantation from a healthy donor. It is caused by T-lymphocytes (a type of immune cell) from the donor that can react badly against the person receiving the transplant (the recipient). Researchers want to see if stimulating the donor T-lymphocytes against another person (a third party) and growing them for 28 days will decrease the chance of developing GVHD.
If you are found to be eligible to take part in this study, you will receive the below treatment, including chemotherapy and radiation, before your stem cell transplantation. These include rituximab, cyclophosphamide, fludarabine, and mesna. Rituximab is designed to attach to lymphoma cells, causing them to die. Cyclophosphamide is designed to destroy cancer cells by interfering with their multiplication and slowing or stopping their growth and spread throughout the body. Fludarabine is designed to interfere with DNA repair enzymes so that the leukemic cell cannot repair damaged DNA. This increases the likelihood of the cell dying. Mesna is a drug that lowers the risk of bladder side effects by the cyclophosphamide. Total body radiation is given to to reduce the risk of transplant rejection.
Participants with CLL or lymphoma will receive Rituxan (rituximab) by vein, given over several hours for each dose. The first rituximab dose is 13 days before the transplant. This will be followed by 3 more doses of rituximab, given 6 days before the transplant, and 1 and 8 days after the transplant. All participants will receive fludarabine by vein over 30 minutes once per day for 4 days, starting 6 days before the transplant. All participants will also receive cyclophosphamide by vein over 2 hours. The cyclophosphamide will be given immediately after the first dose of fludarabine. All participants will also receive a continuous infusion of mesna by vein for 24 hours after receiving the cyclophosphamide. One day before transplantation, you will have total body radiation.
After receiving total body radiation, you will receive your stem cell transplantation. On the day of the transplant, you will receive the anti-third party T Lymphocytes (CTLs) by vein. This will be followed by vein infusion of stem cells from the donor. A sample of the anti-third party T-cells cells will also be tested for immune function.
All participants will receive sirolimus by mouth for 10 days, starting 2 days before transplantation. Sirolimus is an immunosuppressive drug which is given to reduce the risk of transplant rejection. You will remain in the hospital for about 4 weeks after the transplant. You will then continue as an outpatient in the Houston area for 100 days after your transplantation, or until your doctor feels it is okay for you to leave the Houston area.
If your disease gets worse after your transplantation, you may receive additional immune cells from the donor (DLI-donor lymphocyte infusion).You may be taken off this study if the transplant does not grow or is rejected, if not enough of the CTLs can be produced, if your disease continues to get worse after receiving additional donors cells, or if you experience any intolerable side effects.
You will have frequent blood tests as medically necessary to evaluate your medical condition. About 3 tablespoons of blood will be collected for immune function testing at 1, 2, 3, 6 and 12 months after the transplant. You will have a bone marrow biopsy, x-rays, and CT scans for evaluation of the cancer at 1, 3, 6, 9, and 12 months after the transplant. The study is over after 1 year. You will be followed-up after that time for routine care, as the doctors feels it is necessary.
This is an investigational study. All of the drugs used in this study, have been approved by the FDA in the treatment of cancer and transplantation. The Miltenyi CliniMACS System which is used to purify stem cells and the anti-third party CTLs has not been approved by the FDA, and its use in this study is experimental. Up to 24 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Being tested
- Rituximab, Cyclophosphamide, Fludarabine, Mesna, Radiation Treatment
- Keywords
- Chronic Lymphocytic Leukemia, Lymphoma, Myeloma, Leukemia, Anti-Third Party Cytolytic Lymphocytes, Indolent Lymphoid Malignancies, Fludarabine, Fludara, Rituximab, Rituxan, Cyclophosphamide, Cytoxan®, Neosar®, Stem Cell Transplantation, T-lymphocytes, Miltenyi CliniMACS System, Graft vs. Host Disease, GVHD, Allogenic Transplant, Sirolimus
- Medical subject headings
- Leukemia, Lymphoma, Neoplasms, Plasma Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
375 mg/m^2 intravenously over several hours on Day -13, followed by 1000 mg/m^2 intravenously on Days -6, 1, and 8.
CyclophosphamideDrug
Also called Cytoxan®, Neosar®
50 mg/kg intravenously over two hours on Day -6, immediately following Fludarabine.
FludarabineDrug
Also called Fludarabine Phosphate, Fludara
40 mg/m^2 intravenously over 30 minutes once per day for 4 days, starting Day -6.
MesnaDrug
10 mg/kg continuous intravenous infusion for 4 hours for total of 6 doses (24 hours) following Cyclophosphamide.
Radiation TreatmentRadiation
Also called XRT, RT, Radiotherapy
2Gy Total body radiation day before transplantation
Stem Cell Transplantation (SCT)Procedure or surgery
Also called Nonmyeloablative Stem Cell Transplantation
Allo CD34+ Selected SCT/Infusion of stem cells.
SirolimusDrug
Also called Rapamycin
6 mg by mouth on day -2 followed by 2 mg daily from day -1 through day +7.
Anti-third Party Cytolytic T-lymphocytes (CTL)Procedure or surgery
Also called Third Party T-Cells, Lymphocytes
Intravenous infusion of anti-third party CTL.
| Study group | Role | What they receive |
|---|---|---|
| Anti-Third Party T Lymphocytes + Nonmyeloablative SCT | Experimental | Anti-Third Party CTL (Cytolytic T-lymphocytes) with Nonmyeloablative SCT (Stem Cell Transplantation)
Rituximab 375 mg/m^2 intravenously over several hours on Day -13, followed by 1000 mg/m^2 intravenously on Days -6, 1, and 8; + Cyclophosphamide 50 mg/kg intravenously over two hours on Day -6, immediately following Fludarabine; + Fludarabine 40 mg/m^2 intravenously over 30 minutes once per day for 4 days, starting Day -6; + Radiation 2Gy Total body radiation day before transplantation + Stem Cell Transplantation + Intravenous infusion of Anti-third Party CTLs. Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna; Radiation: Radiation Treatment; Procedure: Stem Cell Transplantation (SCT); Drug: Sirolimus; Procedure: Anti-third Party Cytolytic T-lymphocytes (CTL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants achieving engraftment without severe Graft-versus-host disease (GVHD)
Number of participants who achieve engraftment without severe GVHD at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells. Engraftment recorded as first day of three (3) consecutive days that the Absolute neutrophil count (ANC) exceeds 0.5 * 109/L. Graft failure is defined as failure to reach an ANC > 0.5 * 109/L within 28 days after transplantation with detectable donor cells on chimerism analysis.
Measured: Baseline to 90 days
Maximally tolerated dose of anti-third party cytolytic T-lymphocytes
Maximally tolerated dose of anti-third party cytolytic T-lymphocytes, defined as the dose which achieve engraftment without severe GVHD at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells. Engraftment recorded as first day of three (3) consecutive days that the Absolute neutrophil count (ANC) exceeds 0.5 * 109/L. For dose-finding, "toxicity" is defined as either death or acute GVHD (aGVHD) within 90 days and "response" is defined as the event the patient is alive and engrafted at day 30.
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Terminated due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard E. Champlin, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473551
- Sponsor's protocol ID
- 2005-0682
- Status last verified
- Dec 2011
- First submitted
- 11 May 2007
- Last updated
- 19 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Treatment of Indolent Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00473551
- Acronym / sponsor ID
- 2005-0682
- Keywords
- Chronic Lymphocytic Leukemia, Lymphoma, Myeloma, Leukemia, Anti-Third Party Cytolytic Lymphocytes, Indolent Lymphoid Malignancies, Fludarabine, Fludara
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 15 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes, defined as the dose which achieve engraftment without severe GVHD (graft-vs-host disease) at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells.
Secondary Objective:
- Toxicity, response rate, time to progression and overall survival.
Detailed description
GVHD can be a major problem after stem cell transplantation from a healthy donor. It is caused by T-lymphocytes (a type of immune cell) from the donor that can react badly against the person receiving the transplant (the recipient). Researchers want to see if stimulating the donor T-lymphocytes against another person (a third party) and growing them for 28 days will decrease the chance of developing GVHD.
If you are found to be eligible to take part in this study, you will receive the below treatment, including chemotherapy and radiation, before your stem cell transplantation. These include rituximab, cyclophosphamide, fludarabine, and mesna. Rituximab is designed to attach to lymphoma cells, causing them to die. Cyclophosphamide is designed to destroy cancer cells by interfering with their multiplication and slowing or stopping their growth and spread throughout the body. Fludarabine is designed to interfere with DNA repair enzymes so that the leukemic cell cannot repair damaged DNA. This increases the likelihood of the cell dying. Mesna is a drug that lowers the risk of bladder side effects by the cyclophosphamide. Total body radiation is given to to reduce the risk of transplant rejection.
Participants with CLL or lymphoma will receive Rituxan (rituximab) by vein, given over several hours for each dose. The first rituximab dose is 13 days before the transplant. This will be followed by 3 more doses of rituximab, given 6 days before the transplant, and 1 and 8 days after the transplant. All participants will receive fludarabine by vein over 30 minutes once per day for 4 days, starting 6 days before the transplant. All participants will also receive cyclophosphamide by vein over 2 hours. The cyclophosphamide will be given immediately after the first dose of fludarabine. All participants will also receive a continuous infusion of mesna by vein for 24 hours after receiving the cyclophosphamide. One day before transplantation, you will have total body radiation.
After receiving total body radiation, you will receive your stem cell transplantation. On the day of the transplant, you will receive the anti-third party T Lymphocytes (CTLs) by vein. This will be followed by vein infusion of stem cells from the donor. A sample of the anti-third party T-cells cells will also be tested for immune function.
All participants will receive sirolimus by mouth for 10 days, starting 2 days before transplantation. Sirolimus is an immunosuppressive drug which is given to reduce the risk of transplant rejection. You will remain in the hospital for about 4 weeks after the transplant. You will then continue as an outpatient in the Houston area for 100 days after your transplantation, or until your doctor feels it is okay for you to leave the Houston area.
If your disease gets worse after your transplantation, you may receive additional immune cells from the donor (DLI-donor lymphocyte infusion).You may be taken off this study if the transplant does not grow or is rejected, if not enough of the CTLs can be produced, if your disease continues to get worse after receiving additional donors cells, or if you experience any intolerable side effects.
You will have frequent blood tests as medically necessary to evaluate your medical condition. About 3 tablespoons of blood will be collected for immune function testing at 1, 2, 3, 6 and 12 months after the transplant. You will have a bone marrow biopsy, x-rays, and CT scans for evaluation of the cancer at 1, 3, 6, 9, and 12 months after the transplant. The study is over after 1 year. You will be followed-up after that time for routine care, as the doctors feels it is necessary.
This is an investigational study. All of the drugs used in this study, have been approved by the FDA in the treatment of cancer and transplantation. The Miltenyi CliniMACS System which is used to purify stem cells and the anti-third party CTLs has not been approved by the FDA, and its use in this study is experimental. Up to 24 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-Third Party T Lymphocytes + Nonmyeloablative SCT | Experimental | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Mesna, Radiation: Radiation Treatment, Procedure: Stem Cell Transplantation (SCT), Drug: Sirolimus, Procedure: Anti-third Party Cytolytic T-lymphocytes (CTL)Anti-Third Party CTL (Cytolytic T-lymphocytes) with Nonmyeloablative SCT (Stem Cell Transplantation) Rituximab 375 mg/m^2 intravenously over several hours on Day -13, followed by 1000 mg/m^2 intravenously on Days -6, 1, and 8; + Cyclophosphamide 50 mg/kg intravenously over two hours on Day -6, immediately following Fludarabine; + Fludarabine 40 mg/m^2 intravenously over 30 minutes once per day for 4 days, starting Day -6; + Radiation 2Gy Total body radiation day before transplantation + Stem Cell Transplantation + Intravenous infusion of Anti-third Party CTLs. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-70
- Confirmed diagnosis of follicular lymphoma, mantle cell lymphoma, chronic lymphocyte leukemia/small lymphocytic lymphoma or multiple myeloma. Patients must have had persistent or progressive disease despite initial chemotherapy. Patients must have achieved a partial or complete response to their most recent chemotherapy.
- Patients must have an human leukocyte antigen (HLA) matched (HLA-A, B, C DR or DQ) related donor who is seropositive against Epstein Barr virus and capable of donating peripheral blood mononuclear cells and peripheral blood progenitor cells.
- Patient must be HLA completely mismatched for HLA class I loci (A, B and C) with the 3rd party stimulator cells. HLA-A (330301, 310102) HLA-B (5801,150101[62]) HLA-C (0302, 030301)
- Zubrod Performance Scale (PS) of 0 or 1
Key exclusion criteria (4 listed)
- Uncontrolled infection
- HIV, hepatitis B surface antigen or hepatitis C seropositive
- serum glutamic-pyruvic transaminase (SGPT) > 200 IU/ml
- Pregnant or lactating women i.e., positive Beta human chorionic gonadotrophin (hCG) test in a woman with child bearing potential. Child bearing potential is defined as not post-menopausal for 12 months or no previous surgical sterilization.
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: Rituxan375 mg/m^2 intravenously over several hours on Day -13, followed by 1000 mg/m^2 intravenously on Days -6, 1, and 8. | Drug | Anti-Third Party T Lymphocytes + Nonmyeloablative SCT |
| CyclophosphamideAlso: Cytoxan®, Neosar®50 mg/kg intravenously over two hours on Day -6, immediately following Fludarabine. | Drug | Anti-Third Party T Lymphocytes + Nonmyeloablative SCT |
| FludarabineAlso: Fludarabine Phosphate, Fludara40 mg/m^2 intravenously over 30 minutes once per day for 4 days, starting Day -6. | Drug | Anti-Third Party T Lymphocytes + Nonmyeloablative SCT |
| Mesna10 mg/kg continuous intravenous infusion for 4 hours for total of 6 doses (24 hours) following Cyclophosphamide. | Drug | Anti-Third Party T Lymphocytes + Nonmyeloablative SCT |
| Radiation TreatmentAlso: XRT, RT, Radiotherapy2Gy Total body radiation day before transplantation | Radiation | Anti-Third Party T Lymphocytes + Nonmyeloablative SCT |
| Stem Cell Transplantation (SCT)Also: Nonmyeloablative Stem Cell TransplantationAllo CD34+ Selected SCT/Infusion of stem cells. | Procedure or surgery | Anti-Third Party T Lymphocytes + Nonmyeloablative SCT |
| SirolimusAlso: Rapamycin6 mg by mouth on day -2 followed by 2 mg daily from day -1 through day +7. | Drug | Anti-Third Party T Lymphocytes + Nonmyeloablative SCT |
| Anti-third Party Cytolytic T-lymphocytes (CTL)Also: Third Party T-Cells, LymphocytesIntravenous infusion of anti-third party CTL. | Procedure or surgery | Anti-Third Party T Lymphocytes + Nonmyeloablative SCT |
Primary outcome
Number of Participants achieving engraftment without severe Graft-versus-host disease (GVHD)
Time frame: Baseline to 90 days
Number of participants who achieve engraftment without severe GVHD at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells. Engraftment recorded as first day of three (3) consecutive days that the Absolute neutrophil count (ANC) exceeds 0.5 * 109/L. Graft failure is defined as failure to reach an ANC > 0.5 * 109/L within 28 days after transplantation with detectable donor cells on chimerism analysis.
Maximally tolerated dose of anti-third party cytolytic T-lymphocytes
Time frame: Baseline to 90 days
Maximally tolerated dose of anti-third party cytolytic T-lymphocytes, defined as the dose which achieve engraftment without severe GVHD at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells. Engraftment recorded as first day of three (3) consecutive days that the Absolute neutrophil count (ANC) exceeds 0.5 * 109/L. For dose-finding, "toxicity" is defined as either death or acute GVHD (aGVHD) within 90 days and "response" is defined as the event the patient is alive and engrafted at day 30.
Results and safety
The study was stopped early (reason given: Terminated due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
- MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Richard E. Champlin, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rituximab, Cyclophosphamide and Fludarabine in people with Leukemia and Lymphoma, run by M.D. Anderson 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 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated due to slow accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants achieving engraftment without severe Graft-versus-host disease (GVHD) (time frame: Baseline to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2011.