LeukemiaPhase 2NCT01118013
Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant
A Phase 2 study testing anti-thymocyte globulin, donor lymphocytes and filgrastim in people with Leukemia and Lymphoma, run by Alliance for Clinical Trials in Oncology at 10 sites in United States.
Trial summary
RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Read more about this study
- Who is it for?
- Ages Up to 69 years
- Conditions the study is for
- Leukemia, Lymphoma, Lymphoproliferative Disorder
- What is being tested?
- anti-thymocyte globulin, donor lymphocytes and filgrastim
- 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
- 6 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2010to Aug 2013
- 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 Up to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed hematologic malignancies:
- Chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL)
- Absolute lymphocytosis of > 5,000/μL
- Lymphocytes must appear morphologically mature with < 55% prolymphocytes (CLL)
- Patients with > 55% prolymphocytes are considered as having PLL
- Lymphocyte phenotype with expression of CD20, CD19, and CD5 (CLL)
- Non-Hodgkin lymphoma
- Any WHO classification of histologic subtype
- Core biopsies acceptable for primary diagnosis and immunophenotyping
- Bone marrow biopsies as sole means of diagnosis not allowed for follicular lymphoma
- Hodgkin lymphoma
- Any WHO classification of histologic subtype
- Core biopsies acceptable for primary diagnosis and immunophenotyping
- Bone marrow biopsy is required
- Multiple myeloma
- Patients must have active disease requiring treatment (Durie-Salmon stage I-III)
- Acute myeloid leukemia
- Must have < 10% bone marrow blasts and no circulating blasts
- Myelodysplastic syndrome (MDS)
- MDS as define by WHO criteria
- Must have < 10% marrow blasts
- Relapsed or progressive disease or myelodysplasia ≥ 6 months after prior high-dose chemotherapy with autologous hematopoietic cell support
- Prior syngeneic transplantation allowed
- Healthy donor meeting one of the following criteria:
- HLA-identical sibling (6/6)
- Serologic typing for class I (A, B) and molecular typing for class II (DRB1) required
- 8/8 matched-unrelated donor
- Molecular identity at HLA A, B, C, and DRB1 by high-resolution typing required
- No syngeneic donors
PATIENT CHARACTERISTICS:
- Creatinine clearance ≥ 40 mL/min
- Total bilirubin ≤ 2 mg/dL
- AST ≤ 3 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- DLCO ≥ 40% with no symptomatic pulmonary disease
- LVEF ≥ 30% by MUGA or ECHO
- No uncontrolled diabetes mellitus or active serious infection
- No known hypersensitivity to E.coli-derived products
- No HIV infection
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks should elapse between prior standard cytotoxic chemotherapy, radiation therapy, or surgery and the planned start of the preparative regimen on day -7
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240
Union Hospital of Cecil County
Elkton MD, Maryland, 21921
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, 32803-1273
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation as Second Transplantation for Patients With Disease Relapse or Myelodysplasia After Prior Autologous Transplantation
RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with relapsed hematologic malignancies or secondary myelodysplasia previously treated with high-dose chemotherapy and autologous stem cell transplant .
Read the detailed description
OBJECTIVES:
Primary
- To demonstrate the efficacy of performing reduced-intensity conditioning allogeneic hematopoietic cell transplantation in patients with relapsed hematologic malignancies or secondary myelodysplasia after completion of prior high-dose chemotherapy and autologous hematopoietic stem cell transplantation.
- To compare the strategy of this regimen with the strategy used in CALGB-100002.
Secondary
- To describe the response rate at 6 and 12 months in patients treated with this regimen.
- To describe the time-to-progression in patients treated with this regimen.
- To determine the ability to use pharmacokinetic-directed busulfan to achieve AUC within 20% of target AUC in > 80% of patients.
- To determine percent of donor chimerism in T-cell, myeloid and B-cell populations achieved with this regimen compared with CALGB-100002.
- To determine the risk of acute and chronic graft-versus-host disease and other toxicities of this regimen in these patients.
- To describe the overall survival and disease-free survival of patients treated on this regimen.
- To determine the rate of viral, bacterial, and fungal opportunistic infections occurring in the first year after transplantation compared with CALGB-100002.
OUTLINE: This is a multicenter study.
- Preparative Regimen:
- Busulfan test dose: Patients receive busulfan IV over 45 minutes once during days -14 and -9.
- Busulfan treatment dose: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and busulfan IV over 3 hours on days -6 to -3.
- Graft-vs-Host Disease (GVHD) Prophylaxis:
- HLA-identical donor: Patients receive antithymocyte globulin IV over 6-10 hours on days -6 to -5; oral tacrolimus twice daily on days -2 to 90 followed by a taper* as tolerated until day 150 or 180; and methotrexate IV on days 1, 3, and 6.
NOTE: * Tacrolimus may be tapered on days 60-90 if donor chimerism of CD3+ cells is < 50% at day 60 or patient has progressive disease.
- Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60.
- Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover.
- Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks.
Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years.
- Conditions
- Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Being tested
- anti-thymocyte globulin, donor lymphocytes, filgrastim, therapeutic allogeneic lymphocytes, busulfan
- Keywords
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), juvenile myelomonocytic leukemia, prolymphocytic leukemia, recurrent adult acute myeloid leukemia, recurrent adult T-cell leukemia/lymphoma, recurrent childhood acute myeloid leukemia, refractory chronic lymphocytic leukemia, recurrent adult Hodgkin lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult grade III lymphomatoid granulomatosis, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent childhood grade III lymphomatoid granulomatosis
- Medical subject headings
- Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinBiological
donor lymphocytesBiological
filgrastimBiological
therapeutic allogeneic lymphocytesBiological
busulfanDrug
methotrexateDrug
tacrolimusDrug
reduced-intensity transplant conditioning procedureOther
allogeneic hematopoietic stem cell transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60.
Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover.
Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks.
Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years. Receives: Biological: anti-thymocyte globulin; Biological: donor lymphocytes; Biological: filgrastim; Biological: therapeutic allogeneic lymphocytes; Drug: busulfan; Drug: fludarabine phosphate; Drug: methotrexate; Drug: mycophenolate mofetil; Drug: tacrolimus; Other: reduced-intensity transplant conditioning procedure; Procedure: allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS)
EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method.
Measured: Duration of study (up to 5.5 years)
Comparison of EFS Distribution to That of CALGB-100002
EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test.
Measured: 2 years
Secondary outcomes (3)
Complete Response Rate
Complete response (CR) rate is reported as the percentage of participants who achieved a CR.
Measured: Up to 5.5 years
Overall Survival
Overall survival (OS) was defined as the transplant from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
Measured: Up to 5.5 years
Rate of Opportunistic Infections
Percent of participants who have an opportunistic (viral, bacterial and fungal) infection in the first year following transplant.
Measured: 1 year post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2012
- Study completionAug 2013
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.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Asad Bashey, MD, PhD, Principal investigator, Blood and Marrow Transplant Group of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118013
- Sponsor's protocol ID
- CALGB-100601
- Other IDs
- CALGB-100601, CDR0000667954
- Status last verified
- Feb 2017
- First submitted
- 5 May 2010
- Last updated
- 24 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation as Second Transplantation for Patients With Disease Relapse or Myelodysplasia After Prior Autologous Transplantation
- ClinicalTrials.gov ID
- NCT01118013
- Acronym / sponsor ID
- CALGB-100601
- Conditions
- Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Keywords
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), juvenile myelomonocytic leukemia, prolymphocytic leukemia, recurrent adult acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Posted 24 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with relapsed hematologic malignancies or secondary myelodysplasia previously treated with high-dose chemotherapy and autologous stem cell transplant .
Detailed description
OBJECTIVES:
Primary
- To demonstrate the efficacy of performing reduced-intensity conditioning allogeneic hematopoietic cell transplantation in patients with relapsed hematologic malignancies or secondary myelodysplasia after completion of prior high-dose chemotherapy and autologous hematopoietic stem cell transplantation.
- To compare the strategy of this regimen with the strategy used in CALGB-100002.
Secondary
- To describe the response rate at 6 and 12 months in patients treated with this regimen.
- To describe the time-to-progression in patients treated with this regimen.
- To determine the ability to use pharmacokinetic-directed busulfan to achieve AUC within 20% of target AUC in > 80% of patients.
- To determine percent of donor chimerism in T-cell, myeloid and B-cell populations achieved with this regimen compared with CALGB-100002.
- To determine the risk of acute and chronic graft-versus-host disease and other toxicities of this regimen in these patients.
- To describe the overall survival and disease-free survival of patients treated on this regimen.
- To determine the rate of viral, bacterial, and fungal opportunistic infections occurring in the first year after transplantation compared with CALGB-100002.
OUTLINE: This is a multicenter study.
- Preparative Regimen:
- Busulfan test dose: Patients receive busulfan IV over 45 minutes once during days -14 and -9.
- Busulfan treatment dose: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and busulfan IV over 3 hours on days -6 to -3.
- Graft-vs-Host Disease (GVHD) Prophylaxis:
- HLA-identical donor: Patients receive antithymocyte globulin IV over 6-10 hours on days -6 to -5; oral tacrolimus twice daily on days -2 to 90 followed by a taper* as tolerated until day 150 or 180; and methotrexate IV on days 1, 3, and 6.
NOTE: * Tacrolimus may be tapered on days 60-90 if donor chimerism of CD3+ cells is < 50% at day 60 or patient has progressive disease.
- Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60.
- Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover.
- Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks.
Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: anti-thymocyte globulin, Biological: donor lymphocytes, Biological: filgrastim, Biological: therapeutic allogeneic lymphocytes, Drug: busulfan, Drug: fludarabine phosphate, Drug: methotrexate, Drug: mycophenolate mofetil, Drug: tacrolimus, Other: reduced-intensity transplant conditioning procedure, Procedure: allogeneic hematopoietic stem cell transplantation, Procedure: peripheral blood stem cell transplantationMatched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60. Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover. Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks. Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years. |
Who may qualify
- Ages
- Up to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| anti-thymocyte globulin | Biological | Treatment |
| donor lymphocytes | Biological | Treatment |
| filgrastim | Biological | Treatment |
| therapeutic allogeneic lymphocytes | Biological | Treatment |
| busulfan | Drug | Treatment |
| fludarabine phosphate | Drug | Treatment |
| methotrexate | Drug | Treatment |
| mycophenolate mofetil | Drug | Treatment |
| tacrolimus | Drug | Treatment |
| reduced-intensity transplant conditioning procedure | Other | Treatment |
| allogeneic hematopoietic stem cell transplantation | Procedure or surgery | Treatment |
| peripheral blood stem cell transplantation | Procedure or surgery | Treatment |
Primary outcome
Event-free Survival (EFS)
Time frame: Duration of study (up to 5.5 years)
EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method.
Comparison of EFS Distribution to That of CALGB-100002
Time frame: 2 years
EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test.
3 secondary outcomes
Complete Response Rate
Time frame: Up to 5.5 years
Overall Survival
Time frame: Up to 5.5 years
Rate of Opportunistic Infections
Time frame: 1 year post transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- 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.
Asad Bashey, MD, PhD principal investigator
Blood and Marrow Transplant Group of Georgia
10 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 anti-thymocyte globulin, donor lymphocytes and filgrastim in people with Leukemia and Lymphoma, run by Alliance for Clinical Trials in Oncology at 10 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?
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 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 24 Mar 2017). 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?
Event-free Survival (EFS) (time frame: Duration of study (up to 5.5 years)). 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 24 Mar 2017.