LeukemiaPhase 2NCT00045305
Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes
A Phase 2 study testing Cyclosporine, Methotrexate and Photopheresis in people with Leukemia and Myelodysplastic Syndromes, run by Eastern Cooperative Oncology Group at 6 sites in United States.
Trial summary
RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune system from rejecting the donor's stem… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- What is being tested?
- Cyclosporine, Methotrexate and Photopheresis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesUnited States
- Study dates
- 24 Oct 2006to Sep 2014
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- One of the following cytologically proven myelodysplastic syndromes
- Refractory anemia (RA)
- RA with ringed sideroblasts
- RA with excess blasts
- Chronic myelomonocytic leukemia
- International Prognosis Scoring System (IPSS) score of at least 0.5 OR red cell transfusion dependence for at least 6 months (2 units per month)
Show all 31Show fewer
- Patients with an IPSS score less than 0.5 may be eligible provided they previously had a higher IPSS score and received chemotherapy at that time
- Suitable human leukocyte antigen (HLA)-matched donor (related or unrelated) available
- No cord blood donors
- Related donors must be genotypically matched (HLA A, B and DR) at 5/6 or 6/6 loci and may be a sibling, parent, or child
- Unrelated donors must have high resolution typing done at A, B, C and DR, and must be matched at all or may have a single antigen or allele mismatch at no more than one of these loci
- Patients must have < 20% blasts on bone marrow study within 1 month of study entry
- Age of 18 to 70 years
- Eastern Cooperative Oncology Group performance status 0-1
- Life expectancy at least 6 months
- At least 90 days since prior autologous bone marrow transplantation
- Serum erythropoietin level greater than 100 for patients who have not received a prior course of epoetin alfa
- No iron deficiency
- Iron deficiency anemia treated with iron replacement therapy allowed
- Bilirubin less than 2.0 mg/dL
- Alkaline phosphatase less than 2 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times ULN
- Creatinine less than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min
- Left ventricular ejection fraction (LVEF) at least 45% by Multigated Acquisition scan (MUGA) or echocardiogram
- Carbon Monoxide Diffusing Capacity (DLCO) at least 50% of predicted (corrected for hemoglobin)
- Forced expiratory volume in 1 second (FEV_1) at least 50% of predicted
- Recovered from prior chemotherapy
- Physically and psychologically capable of undergoing study regimen
- Able to receive 600 cGy of total body irradiation
- HIV negative
- Negative pregnancy test
Who cannot join
- Pregnant or nursing
- Having other medical condition that would reduce life expectancy
- Active ongoing infection
- Prior myeloablative or nonmyeloablative allogeneic transplantation for Myelodysplastic syndrome or acute myeloid leukemia
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Tufts-NEMC Cancer Center
Boston, Massachusetts, 02111
Jewish Hospital Cancer Center
Cincinnati, Ohio, 45236
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499
About this study
Official title: A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplant for the Treatment of Myelodysplastic Syndromes
RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving pentostatin before transplant and cyclosporine or mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving pentostatin together with photopheresis and total-body irradiation work before donor bone marrow transplant in treating patients with myelodysplastic syndromes.
Read the detailed description
OBJECTIVES:
- Determine the complete response rate in patients with myelodysplastic syndromes treated with reduced-intensity allogeneic bone marrow transplantation, including photopheresis, total body irradiation, and pentostatin.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the engraftment rate of donor cells in patients treated with this regimen.
- Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a single-arm, two-stage, multicenter phase II study.
- Preparative Regimen: Patients undergo photopheresis using methoxsalen on days -7 and -6 and receive pentostatin intravenously (IV )continuously on days -5 and -4. Total body irradiation is administered on days -3 and -2 for a total of 3 doses.
- Transplantation: Allogeneic bone marrow or peripheral blood stem cells are infused on day 0.
- Acute graft-vs-host-disease (GVHD) prophylaxis: Patients receive cyclosporine IV on days -1 to 30 and then orally every 12 hours. Cyclosporine dose is then tapered beginning after day 50 and continuing for 6 months in the absence of GVHD. Once cyclosporine dose is significantly decreased, oral mycophenolate mofetil (MMF) is then administered twice a day. MMF dose is then tapered for 12 months in the absence of GVHD. Patients also receive methotrexate IV on days 1 and 3.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 33 patients would be accrued for this study within 2.1 years.
- Being tested
- Cyclosporine, Methotrexate, Photopheresis, Mycofenolate mofetil, Pentostatin
- Keywords
- chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, refractory anemia, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, secondary myelodysplastic syndromes, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelomonocytic, Chronic, Anemia, Refractory, Anemia, Refractory, with Excess of Blasts, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporineDrug
Also called Sandimmune®, cyclosporin A, Neoral®Gengraf®, Gengraf®
Immunosuppressant
MethotrexateDrug
Also called Methotrexate sodium, MTX, Mexate, Mexate-AQ
Antimetabolite
PhotopheresisDrug
Also called 8-methoxypsoralen, Uvadex ®, Methoxsalen
Psoralens
Mycofenolate mofetilDrug
Also called Cellcept®, RS-61443, mycophenolic acid, Lilly-68618
an antibiotic with immunosuppressamt properties isolated from Penicillium spp
PentostatinDrug
Also called DCF, 2-Deoxycoformycin, Nipent
Purine analogue
allogeneic bone marrowProcedure or surgery
Unmanipulated allogeneic bone marrow
peripheral blood stem cellProcedure or surgery
G-CSF mobilized peripheral blood stem cell
Total body irradiationRadiation
Also called radiation therapy
a total of 600 cGy given in 3 200 cGy fractionated doses
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD. Receives: Drug: Cyclosporine; Drug: Methotrexate; Drug: Photopheresis; Drug: Mycofenolate mofetil; Drug: Pentostatin; Procedure: allogeneic bone marrow; Procedure: peripheral blood stem cell; Radiation: Total body irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate
Completed response is defined as:
Bone marrow evaluation: Repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia (see dysplasia qualifier under peripheral blood evaluation).
Peripheral blood evaluation [absolute values must last at least 2 months] Hemoglobin >11 g/dl (untransfused, not on erythropoietin) Neutrophils (1500/mm3 (not on a myeloid growth factor)) Platelets (100,000/mm3 (not on a thrombopoetic agent)) Blasts - 0% No dysplasia. No detectable cytogenetic abnormality, if preexisting abnormality was present
Measured: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.
Secondary outcomes (5)
Number of Patients Who Developed Disease Progression After Achieving Complete Response
Disease free survival (DFS) was listed as a secondary endpoint in the study protocol, which would be assessed in patients who achieved complete response (CR). It was defined to be time from CR to documented progression or to death without progression. Patients without documented progression or death reported were censored at the time of last disease evaluation. However, due to the small number of patients with CR, the number of patients who developed disease progression was reported here.
Measured: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.
Overall Survival
Overall survival (OS) is defined to be the time from registration to death from any cause, with follow-up censored at the date of last contact. Kaplan-Meier method was used to estimate the distribution of OS.
Measured: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.
Proportion of Graft Versus Host Disease
Proportion of Graft versus Host Disease is calculated as number of patients with Graft versus Host Disease divided by all eligible and treated patients
Measured: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.
Time to Engraftment for Neutrophil
Time to neutrophil engraftment is defined from date of infusion to date of neutrophil engraftment. Neutrophil engraftment is defined as ANC > 500/mm3 on two consecutive measurements. The date of engraftment is the date of the first ANC > 500/mm3.
Measured: Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.
Time to Engraftment for Platelet
Time to platelet engraftment is defined from date of infusion to date of platelet engraftment. The platelet engraftment is defined as platelets > 20,000 on two consecutive measurements, at least seven days apart, without platelet transfusions in between and for at least three days before the first measurement that is over 20,000. The date of engraftment is the date of the first measurement that is over 20,000.
Measured: Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start24 Oct 2006
- Primary completionFeb 2014
- Study completionSep 2014
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 LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Selina M. Luger, MD, Study chair, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00045305
- Sponsor's protocol ID
- CDR0000256928
- Other IDs
- E1902, U10CA021115
- Status last verified
- Jun 2023
- First submitted
- 6 Sep 2002
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplant for the Treatment of Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00045305
- Acronym / sponsor ID
- CDR0000256928
- Keywords
- chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, refractory anemia, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, secondary myelodysplastic syndromes, atypical chronic myeloid leukemia, BCR-ABL1 negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Oct 2006 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 19 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving pentostatin before transplant and cyclosporine or mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving pentostatin together with photopheresis and total-body irradiation work before donor bone marrow transplant in treating patients with myelodysplastic syndromes.
Detailed description
OBJECTIVES:
- Determine the complete response rate in patients with myelodysplastic syndromes treated with reduced-intensity allogeneic bone marrow transplantation, including photopheresis, total body irradiation, and pentostatin.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the engraftment rate of donor cells in patients treated with this regimen.
- Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a single-arm, two-stage, multicenter phase II study.
- Preparative Regimen: Patients undergo photopheresis using methoxsalen on days -7 and -6 and receive pentostatin intravenously (IV )continuously on days -5 and -4. Total body irradiation is administered on days -3 and -2 for a total of 3 doses.
- Transplantation: Allogeneic bone marrow or peripheral blood stem cells are infused on day 0.
- Acute graft-vs-host-disease (GVHD) prophylaxis: Patients receive cyclosporine IV on days -1 to 30 and then orally every 12 hours. Cyclosporine dose is then tapered beginning after day 50 and continuing for 6 months in the absence of GVHD. Once cyclosporine dose is significantly decreased, oral mycophenolate mofetil (MMF) is then administered twice a day. MMF dose is then tapered for 12 months in the absence of GVHD. Patients also receive methotrexate IV on days 1 and 3.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 33 patients would be accrued for this study within 2.1 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Cyclosporine, Drug: Methotrexate, Drug: Photopheresis, Drug: Mycofenolate mofetil, Drug: Pentostatin, Procedure: allogeneic bone marrow, Procedure: peripheral blood stem cell, Radiation: Total body irradiationPreparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses. Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient. Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- One of the following cytologically proven myelodysplastic syndromes
- International Prognosis Scoring System (IPSS) score of at least 0.5 OR red cell transfusion dependence for at least 6 months (2 units per month)
- Suitable human leukocyte antigen (HLA)-matched donor (related or unrelated) available
- Patients must have < 20% blasts on bone marrow study within 1 month of study entry
- Age of 18 to 70 years
Key exclusion criteria (4 listed)
- Pregnant or nursing
- Having other medical condition that would reduce life expectancy
- Active ongoing infection
- Prior myeloablative or nonmyeloablative allogeneic transplantation for Myelodysplastic syndrome or acute myeloid leukemia
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 |
|---|---|---|
| CyclosporineAlso: Sandimmune®, cyclosporin A, Neoral®Gengraf®, Gengraf®Immunosuppressant | Drug | Arm I |
| MethotrexateAlso: Methotrexate sodium, MTX, Mexate, Mexate-AQAntimetabolite | Drug | Arm I |
| PhotopheresisAlso: 8-methoxypsoralen, Uvadex ®, MethoxsalenPsoralens | Drug | Arm I |
| Mycofenolate mofetilAlso: Cellcept®, RS-61443, mycophenolic acid, Lilly-68618an antibiotic with immunosuppressamt properties isolated from Penicillium spp | Drug | Arm I |
| PentostatinAlso: DCF, 2-Deoxycoformycin, NipentPurine analogue | Drug | Arm I |
| allogeneic bone marrowUnmanipulated allogeneic bone marrow | Procedure or surgery | Arm I |
| peripheral blood stem cellG-CSF mobilized peripheral blood stem cell | Procedure or surgery | Arm I |
| Total body irradiationAlso: radiation therapya total of 600 cGy given in 3 200 cGy fractionated doses | Radiation | Arm I |
Primary outcome
Complete Response Rate
Time frame: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.
Completed response is defined as: Bone marrow evaluation: Repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia (see dysplasia qualifier under peripheral blood evaluation). Peripheral blood evaluation [absolute values must last at least 2 months] Hemoglobin >11 g/dl (untransfused, not on erythropoietin) Neutrophils (1500/mm3 (not on a myeloid growth factor)) Platelets (100,000/mm3 (not on a thrombopoetic agent)) Blasts - 0% No dysplasia. No detectable cytogenetic abnormality, if preexisting abnormality was present
5 secondary outcomes
Number of Patients Who Developed Disease Progression After Achieving Complete Response
Time frame: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.
Overall Survival
Time frame: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.
Proportion of Graft Versus Host Disease
Time frame: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.
Time to Engraftment for Neutrophil
Time frame: Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.
Time to Engraftment for Platelet
Time frame: Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selina M. Luger, MD study chair
Abramson Cancer Center at Penn Medicine
6 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 Cyclosporine, Methotrexate and Photopheresis in people with Leukemia and Myelodysplastic Syndromes, run by Eastern Cooperative Oncology Group at 6 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 31 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: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 19 Jan 2015). 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?
Complete Response Rate (time frame: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.). 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 28 Jun 2023.