Graft Versus Host DiseasePhase 3NCT00366145
Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)
A Phase 3 study testing Prochymal® in people with Graft Versus Host Disease, run by Mesoblast, Inc. at 70 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and gather additional safety information for Prochymal® in participants who have failed to respond to steroid treatment of Grades B-D acute GVHD. Read more about this study
- Who is it for?
- Ages 6 months to 70 years
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- Prochymal®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 70 sitesin 6 countries
- Study dates
- 17 Aug 2006to 28 May 2009
- Phase
- Phase 3
- 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 6 months to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant must be 6 months to 70 years of age, inclusive.
- Participants who have failed to respond to steroid treatment.
- Failure to respond to steroid treatment is defined as any grade B-D (IBMTR) grading of acute GVHD that shows:
- No improvement after 3 days and a duration of no greater than 2 weeks while receiving treatment with methylprednisolone (greater than or equal to 1 mg/kg/day) or equivalent.
- Participant must be treated within 4 days of randomization. In urgent situations 2nd line therapy may be started 24 hours prior to randomization, and Prochymal® must be initiated within the following 3 days.
- Participants who have received an increase in their steroid dose treatment prior to randomization will be eligible for enrollment. An increase in steroid dose will not be considered as second line therapy.
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- Participant must have adequate renal function as defined by: Calculated Creatinine Clearance of >30 milliliters per minute (mL/min) using the Cockcroft-Gault equation.
- For pediatric participants: Schwartz equation: (Participant population: infants over 1 week old through adolescence (<18 years old).
- Participants who are women of childbearing potential must be non-pregnant, not breast-feeding, and use adequate contraception. Male participants must use adequate contraception.
- Participant must have a minimum Karnofsky Performance Level of at least 30 at the time of study entry.
- Participant (or legal representative where appropriate) must be capable of providing written informed consent.
Who cannot join
- Participant has started treatment with second line therapy >24 hours prior to randomization.
- Participant has received agents other than steroids for primary treatment of acute GVHD.
- Participant is participating in the CTN Protocol 0302.
- Participant has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant including uncontrolled infection, heart failure, pulmonary hypertension, etc.
- Participant may not receive any other investigational agents (not approved by the FDA) concurrently during study participation or within 30 days of randomization.
- Participant has a known allergy to bovine or porcine products.
- Participant has received a transplant for a solid tumor disease.
Trial locations and contacts
70 sites in 6 countries.
70 sites in 6 countries
United States47 sites
Emory University
Atlanta, Georgia, 30322
Northside Hospital
Atlanta, Georgia, 30342
University of Maryland/Greenbaum
Baltimore, Maryland, 21201
Indiana Blood and Bone Marrow Transplant Center
Beech Grove, Indiana, 46107
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Tufts-New England Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park
Buffalo, New York, 14263
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois - Chicago
Chicago, Illinois, 60612
Texas Cancer Center at Medical City
Dallas, Texas, 75230
Baylor University
Dallas, Texas, 75246
Univeristy of Texas Southwestern Medical Center
Dallas, Texas, 75390
Karmanos/Wayne State University
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
Duke University
Durham, North Carolina, 27710
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
MD Anderson Cancer Center
Houston, Texas, 77030
Univeristy of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Univeristy of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Louisville
Louisville, Kentucky, 40202
University of Wisconsin Madison
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Yale New Haven Hospital
New Haven, Connecticut, 06520
New York Presbyterian Hospital
New York, New York, 10021
Mount Sinai Medical Center
New York, New York, 10029
Columbia University/New York Presbyterian Hospital
New York, New York, 10032
University of Nebraska
Omaha, Nebraska, 68198
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224
Oregon Health and Science University
Portland, Oregon, 97239
Virginia Commonwealth/Massey Cancer Center
Richmond, Virginia, 23298
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
Texas Research Center
San Antonio, Texas, 78229
Univeristy of California San Francisco
San Francisco, California, 94143
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Louisiana State University
Shreveport, Louisiana, 71130
All Children's Hospital
St. Petersburg, Florida, 33701
Arizona Cancer Center
Tucson, Arizona, 85724
New York Medical College
Valhalla, New York, 10595
Wake Forest Univeristy School of Medicine
Winston-Salem, North Carolina, 27157
Canada12 sites
Co-Medica Research Network
Calgary, Alberta, T1Y6J4
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H2Y9
Hamilton Health Sciences Centre
Hamilton, Ontario, L8N3Z5
London Health Sciences Centre- Westminster Campus
London, Ontario, N6A4G5
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Ottawa Hospital
Ottawa, Ontario, K1H8L6
Hopital Enfant-Jesus
Québec, G1J 1Z4
Hopital du Saint-Sacrement
Québec, G1S4L8
Toronto General Hospital
Toronto, Ontario, M5G 1X8
Princess Margaret Hospital
Toronto, Ontario, M5G1X8
British Columbia's Children's Hospital
Vancouver, British Columbia, V6H3V4
Cancer Care Manitoba
Winnipeg, Manitoba, R3E0V9
United Kingdom5 sites
Bristol Royal Hospital for Children
Bristol, UK, BS2 8BJ
Glasgow Royal Infirmary
Glasgow, UK, G4 OSF
John Radcliffe Hospital
Headington, Oxford, OX3 0Du
Leeds General Infirmary
Leeds, UK, LS1 3EX
Barts & London School of Medicine
London, England, EC1M 6BQ
Australia3 sites
Royal Brisbane Hospital
Herston, Queensland, 4029
Royal Melbourne Hospital
Parkville, Victoria, 3050
Royal Perth Hospital
Perth, Western Australia, 6100
Italy2 sites
IRCCS Policlinico San Matteo
Pavia, 27100
Universia degli Studi di Pesaro
Pesaro, PU, 61100
About this study
Official title: A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
The purpose of this study is to evaluate the efficacy and gather additional safety information for Prochymal® in participants who have failed to respond to steroid treatment of Grades B-D acute GVHD.
Read the detailed description
Approximately 6300 patients receive allogeneic hematopoietic stem cell transplants in the United States each year (International Bone Marrow Transplant Registry [IBMTR], 2003). Nearly 50% (approximately 3,150) of these patients develop acute GVHD (Goker et al). A fraction of these patients (approximately 870) will progress to the severe stages of the disease, Grades III-IV. It is estimated that nearly 82% of those patients with severe acute GVHD will be steroid refractory (Przepiorka et al., 1995) and of these, only 50% of steroid-refractory patients will respond to secondary and tertiary treatments (Greinix et al., 2000). Thus, roughly 350 patients each year face tremendous odds against survival. In addition, most patients who initially responded to secondary and tertiary treatments have a high risk of dying within the first year (Remberger et al., 2001; Anasetti et al., 1994). Development of new therapeutic agents and strategies to rescue patients with steroid refractory, acute GVHD would provide a significant benefit in an area of unmet medical need. Participants will receive standard of care in addition to adult mesenchymal stem cells or placebo.
- Conditions
- Graft Versus Host Disease
- Being tested
- Prochymal®, Placebo, Standard of Care for GVHD
- Keywords
- Acute GVHD, Steroid refractory GVHD, Severe steroid refractory acute GVHD, Steroid refractory, Steroid Refractory Acute Graft Versus Host Disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prochymal®Biological
Also called Mesenchymal Stem Cells
2 infusions of 2 million cells/kg per week for 4 weeks
PlaceboDrug
Also called excipients without adult human mesenchymal stem cells
2 infusions per week for 4 weeks
Standard of Care for GVHDDrug
Institutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy)
| Study group | Role | What they receive |
|---|---|---|
| Prochymal® | Active comparator | Participants who receive standard of care plus treatment with ex vivo cultured adult human mesenchymal stem cells. Receives: Biological: Prochymal®; Drug: Standard of Care for GVHD |
| Placebo | Placebo comparator | Participants who receive standard of care and do not receive treatment with ex vivo cultured adult human mesenchymal stem cells. Receives: Drug: Placebo; Drug: Standard of Care for GVHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants achieving Complete Response of Greater Than or Equal to 28 Days Duration
A complete response was defined as complete resolution of all clinical signs of Graft versus host disease (GVHD)- that had to be maintained for at least 28 consecutive days (durable complete response [DCR]) within 100 days post first infusion.
Measured: up to 100 Days post first infusion
Secondary outcomes (1)
Overall Survival at 180 days Post First Infusion
Percentage of participants who survived at 180 days post first infusion.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study start17 Aug 2006
- Primary completion26 Dec 2008
- Study completion28 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoblast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher James, PA, Study director, Mesoblast, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366145
- Sponsor's protocol ID
- 280
- Status last verified
- Feb 2022
- First submitted
- 17 Aug 2006
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bartholomew A, Sturgeon C, Siatskas M, Ferrer K, McIntosh K, Patil S, Hardy W, Devine S, Ucker D, Deans R, Moseley A, Hoffman R. Mesenchymal stem cells suppress lymphocyte proliferation in vitro and prolong skin graft survival in vivo. Exp Hematol. 2002 Jan;30(1):42-8. doi: 10.1016/s0301-472x(01)00769-x.
PubMed 11823036Deans RJ, Moseley AB. Mesenchymal stem cells: biology and potential clinical uses. Exp Hematol. 2000 Aug;28(8):875-84. doi: 10.1016/s0301-472x(00)00482-3.
PubMed 10989188Lazarus HM, Koc ON, Devine SM, Curtin P, Maziarz RT, Holland HK, Shpall EJ, McCarthy P, Atkinson K, Cooper BW, Gerson SL, Laughlin MJ, Loberiza FR Jr, Moseley AB, Bacigalupo A. Cotransplantation of HLA-identical sibling culture-expanded mesenchymal stem cells and hematopoietic stem cells in hematologic malignancy patients. Biol Blood Marrow Transplant. 2005 May;11(5):389-98. doi: 10.1016/j.bbmt.2005.02.001.
PubMed 15846293Le Blanc K, Rasmusson I, Sundberg B, Gotherstrom C, Hassan M, Uzunel M, Ringden O. Treatment of severe acute graft-versus-host disease with third party haploidentical mesenchymal stem cells. Lancet. 2004 May 1;363(9419):1439-41. doi: 10.1016/S0140-6736(04)16104-7.
PubMed 15121408Le Blanc K, Pittenger M. Mesenchymal stem cells: progress toward promise. Cytotherapy. 2005;7(1):36-45. doi: 10.1080/14653240510018118.
PubMed 16040382Camilleri ET, Gustafson MP, Dudakovic A, Riester SM, Garces CG, Paradise CR, Takai H, Karperien M, Cool S, Sampen HJ, Larson AN, Qu W, Smith J, Dietz AB, van Wijnen AJ. Identification and validation of multiple cell surface markers of clinical-grade adipose-derived mesenchymal stromal cells as novel release criteria for good manufacturing practice-compliant production. Stem Cell Res Ther. 2016 Aug 11;7(1):107. doi: 10.1186/s13287-016-0370-8.
PubMed 27515308
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
- ClinicalTrials.gov ID
- NCT00366145
- Acronym / sponsor ID
- 280
- Conditions
- Graft Versus Host Disease
- Keywords
- Acute GVHD, Steroid refractory GVHD, Severe steroid refractory acute GVHD, Steroid refractory, Steroid Refractory Acute Graft Versus Host Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Mesoblast, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2006 (actual)
- Primary completion
- 26 Dec 2008 (actual)
- Study completion
- 28 May 2009 (actual)
- First posted
- 21 Aug 2006 (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.
The purpose of this study is to evaluate the efficacy and gather additional safety information for Prochymal® in participants who have failed to respond to steroid treatment of Grades B-D acute GVHD.
Detailed description
Approximately 6300 patients receive allogeneic hematopoietic stem cell transplants in the United States each year (International Bone Marrow Transplant Registry [IBMTR], 2003). Nearly 50% (approximately 3,150) of these patients develop acute GVHD (Goker et al). A fraction of these patients (approximately 870) will progress to the severe stages of the disease, Grades III-IV. It is estimated that nearly 82% of those patients with severe acute GVHD will be steroid refractory (Przepiorka et al., 1995) and of these, only 50% of steroid-refractory patients will respond to secondary and tertiary treatments (Greinix et al., 2000). Thus, roughly 350 patients each year face tremendous odds against survival. In addition, most patients who initially responded to secondary and tertiary treatments have a high risk of dying within the first year (Remberger et al., 2001; Anasetti et al., 1994). Development of new therapeutic agents and strategies to rescue patients with steroid refractory, acute GVHD would provide a significant benefit in an area of unmet medical need. Participants will receive standard of care in addition to adult mesenchymal stem cells or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prochymal® | Active comparator | Biological: Prochymal®, Drug: Standard of Care for GVHDParticipants who receive standard of care plus treatment with ex vivo cultured adult human mesenchymal stem cells. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Standard of Care for GVHDParticipants who receive standard of care and do not receive treatment with ex vivo cultured adult human mesenchymal stem cells. |
Who may qualify
- Ages
- 6 months to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Participant must be 6 months to 70 years of age, inclusive.
- Participants who have failed to respond to steroid treatment.
- Failure to respond to steroid treatment is defined as any grade B-D (IBMTR) grading of acute GVHD that shows:
- No improvement after 3 days and a duration of no greater than 2 weeks while receiving treatment with methylprednisolone (greater than or equal to 1 mg/kg/day) or equivalent.
- Participant must be treated within 4 days of randomization. In urgent situations 2nd line therapy may be started 24 hours prior to randomization, and Prochymal® must be initiated within the following 3 days.
Key exclusion criteria (7 listed)
- Participant has started treatment with second line therapy >24 hours prior to randomization.
- Participant has received agents other than steroids for primary treatment of acute GVHD.
- Participant is participating in the CTN Protocol 0302.
- Participant has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant including uncontrolled infection, heart failure, pulmonary hypertension, etc.
- Participant may not receive any other investigational agents (not approved by the FDA) concurrently during study participation or within 30 days of randomization.
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 |
|---|---|---|
| Prochymal®Also: Mesenchymal Stem Cells2 infusions of 2 million cells/kg per week for 4 weeks | Biological | Prochymal® |
| PlaceboAlso: excipients without adult human mesenchymal stem cells2 infusions per week for 4 weeks | Drug | Placebo |
| Standard of Care for GVHDInstitutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy) | Drug | Placebo, Prochymal® |
Primary outcome
Percentage of Participants achieving Complete Response of Greater Than or Equal to 28 Days Duration
Time frame: up to 100 Days post first infusion
A complete response was defined as complete resolution of all clinical signs of Graft versus host disease (GVHD)- that had to be maintained for at least 28 consecutive days (durable complete response [DCR]) within 100 days post first infusion.
1 secondary outcome
Overall Survival at 180 days Post First Infusion
Time frame: Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Background: PubMed 11823036Bartholomew A, Sturgeon C, Siatskas M, Ferrer K, McIntosh K, Patil S, Hardy W, Devine S, Ucker D, Deans R, Moseley A, Hoffman R. Mesenchymal stem cells suppress lymphocyte proliferation in vitro and prolong skin graft survival in vivo. Exp Hematol. 2002 Jan;30(1):42-8. doi: 10.1016/s0301-472x(01)00769-x.
- Background: PubMed 10989188Deans RJ, Moseley AB. Mesenchymal stem cells: biology and potential clinical uses. Exp Hematol. 2000 Aug;28(8):875-84. doi: 10.1016/s0301-472x(00)00482-3.
- Background: PubMed 15846293Lazarus HM, Koc ON, Devine SM, Curtin P, Maziarz RT, Holland HK, Shpall EJ, McCarthy P, Atkinson K, Cooper BW, Gerson SL, Laughlin MJ, Loberiza FR Jr, Moseley AB, Bacigalupo A. Cotransplantation of HLA-identical sibling culture-expanded mesenchymal stem cells and hematopoietic stem cells in hematologic malignancy patients. Biol Blood Marrow Transplant. 2005 May;11(5):389-98. doi: 10.1016/j.bbmt.2005.02.001.
- Background: PubMed 15121408Le Blanc K, Rasmusson I, Sundberg B, Gotherstrom C, Hassan M, Uzunel M, Ringden O. Treatment of severe acute graft-versus-host disease with third party haploidentical mesenchymal stem cells. Lancet. 2004 May 1;363(9419):1439-41. doi: 10.1016/S0140-6736(04)16104-7.
- Background: PubMed 16040382Le Blanc K, Pittenger M. Mesenchymal stem cells: progress toward promise. Cytotherapy. 2005;7(1):36-45. doi: 10.1080/14653240510018118.
- Derived from this study: PubMed 27515308Camilleri ET, Gustafson MP, Dudakovic A, Riester SM, Garces CG, Paradise CR, Takai H, Karperien M, Cool S, Sampen HJ, Larson AN, Qu W, Smith J, Dietz AB, van Wijnen AJ. Identification and validation of multiple cell surface markers of clinical-grade adipose-derived mesenchymal stromal cells as novel release criteria for good manufacturing practice-compliant production. Stem Cell Res Ther. 2016 Aug 11;7(1):107. doi: 10.1186/s13287-016-0370-8.
- Description Click here for more information about this study: A Phase III Study to Evaluate the Efficacy and Safety of Prochymal® (Ex vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Steroid-Refractory Acute GVHDLink 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.
Christopher James, PA study director
Mesoblast, Inc.
70 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prochymal® in people with Graft Versus Host Disease, run by Mesoblast, Inc. at 70 sites in 6 countries.
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 11 inclusion and 7 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: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Canada, United Kingdom, Australia, Italy and 1 more country. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants achieving Complete Response of Greater Than or Equal to 28 Days Duration (time frame: up to 100 Days post first infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00366145, which also lists 6 linked publications.
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 10 Feb 2022.