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Acute Lymphocytic LeukemiaPhase 3NCT01597778

Double Cord Versus Haploidentical (BMT CTN 1101)

A Phase 3 study testing Haploidentical Bone Marrow Transplant and Double Umbilical Cord Blood Transplant in people with Acute Lymphocytic Leukemia and Acute Myelogenous Leukemia, run by Medical College of Wisconsin at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Haploidentical Bone Marrow Transplant and Double Umbilical Cord Blood Transplant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
368 participants
Where
39 sitesUnited States
Study dates
Jun 2012to 11 Sep 2020
Phase
Phase 3
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

  • Patients 18 to 70 years old
  • Patients must have available both: a)One or more potential related mismatched donors (biologic parent(s) or siblings (full or half) or children). At least low resolution DNA based human leukocyte antigen (HLA) typing at HLA-A, -B, and -DRB1 for potential haploidentical sibling donors is required. b)At least two potential umbilical cord blood units identified. Each unit must have a minimum of 1.5 x 10^7/kg pre-cryopreserved total nucleated cell dose. For non-red blood cell depleted units, the minimum pre-cryopreserved total nucleated cell dose of each unit must be at least 2.0 x 10^7/kg. Units must be HLA matched at a minimum of 4/6 to the recipient at HLA-A, HLA-B (at low resolution using DNA based typing) and HLA-DRB1 (at high resolution using DNA based typing). Confirmatory typing is not required for randomization.
  • Acute Lymphoblastic Leukemia (ALL) in first complete remission (CR1) that is NOT considered favorable-risk as defined by the presence of at least one of the following: Adverse cytogenetics such as t(9;22), t(1;19), t(4;11), other Mixed Lineage Leukemia (MLL) rearrangements; White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL)at diagnosis; Recipient age older than 30 years at diagnosis; Time to CR greater than 4 weeks
  • Acute Myelogeneous Leukemia (AML) in CR1 that is NOT considered as favorable-risk. Favorable risk is defined as having one of the following: t(8.21) without CKIT mutation, inv(16) without CKIT mutation or t(16;16), normal karyotype with mutated NPM1 and not FLT-ITD, normal karyotype with double mutated CEBPA, Acute promyelocytic leukemia (APL) in first molecular remission at end of consolidation
  • Acute Leukemias in 2nd or subsequent CR
  • Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR, adult T-cell leukemia/lymphoma in first or subsequent CR
Show all 18Show fewer
  • Burkitt's lymphoma: second or subsequent CR
  • Lymphoma fulfilling the following criteria: Chemotherapy-sensitive (at least stable disease lymphomas that have failed at least 1 prior regimen of multi-agent chemotherapy and are INELIGIBLE for an autologous transplant. Patients with chronic lymphocytic leukemia (CLL) are not eligible regardless of disease status.
  • Performance status: Karnofsky score greater than or equal to 70%.
  • Additional Patient Inclusion Criteria for Conditioning:
  • Patients with Adequate Physical Function as Measured by: a. Cardiac: Left ventricular ejection fraction at rest must be greater than or equal to 40%, or shortening fraction less than 25%; b. Hepatic: Bilirubin less than or equal to 2.5 mg/dL, except for patients with Gilbert's syndrome or hemolysis. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and Alkaline Phosphatase less than 5 x upper limit of normal; c. Renal: Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or GFR)greater than 40 mL/min/1.73m^; d. Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin), forced expiratory volume in one second (FEV1), and forced vital capacity (FVC) greater than 50% predicted;
  • Additional Patient Inclusion Criteria for Patients Assigned to Haploidentical BM Arm: Patients must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1 and have available a related haploidentical BM donor with 2, 3, or 4 HLA-mismatches. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must be HLA identical for at least one antigen (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1. Fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype, and typing of additional family members is not required.
  • Additional Patient Inclusion Criteria for Patients Assigned to Double Umbilical Cord Blood Arm:
  • Patients must have available two UCB units fulfilling the following criteria:
  • Each unit must have a minimum of 1.5 x 10^7/kg pre-cryopreserved total nucleated cell dose. For non-red blood cell depleted units, the minimum pre-cryopreserved total nucleated cell dose of each unit must be at least 2.0 x10^7/kg.
  • Units must be HLA matched at a minimum of 4/6 to the recipient at HLA -A, HLA-B (at low resolution using DNA based typing), and HLA -DRB1 (at high resolution using DNA based typing).
  • Additional graft selection criteria specified in section 2.5
  • Patients must have received at least one cycle of the cytotoxic chemotherapy regimens (or regimen of similar intensity) listed in Appendix D within 3 months of enrollment (measured from the start date of chemotherapy) OR have had an autologous transplant within 24 months of enrollment OR receive 300 cGy as part of the preparative regimen

Who cannot join

  • Patients with suitably matched related or unrelated donor, as defined per institutional practice.
  • Recipients of prior autologous hematopoietic stem cell transplantation are ineligible if disease recurrence occurred less than 6 months from their autologous stem cell transplant.
  • Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
  • Prior allogeneic HCT.
  • Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis.
  • Planned use of prophylactic donor lymphocyte infusion (DLI) therapy.
Show all 10Show fewer
  • Anti-donor HLA antibodies.
  • Additional exclusion criteria:
  • Pregnancy or breast-feeding.
  • Evidence of HIV infection or known HIV positive serology.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • BMT Program at Northside Hospital

    Atlanta, Georgia, 30342

  • Johns Hopkins University

    Baltimore, Maryland, 21231

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • DFCI Massachustts General Hospital

    Boston, Massachusetts, 02114

  • DFCI Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Center

    Buffalo, New York, 14203

  • University of North Carolina Hospital at Chapel Hill

    Chapel Hill, North Carolina, 27599-7305

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Jewish Hospital BMT Program

    Cincinnati, Ohio, 45236

  • University Hospitals of Cleveland, Case Western

    Cleveland, Ohio, 44106-5061

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State / Arthur G. James Cancer Hospital

    Columbus, Ohio, 43210

  • Karmanos Cancer Institute/BMT

    Detroit, Michigan, 48201

  • City of Hope National Medical Center

    Duarte, California, 91010-3000

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • University of Florida College of Medicine (Shands)

    Gainesville, Florida, 32610-0277

  • Penn State College of Medicine - The Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Univesity of Texas, MD Anderson CRC

    Houston, Texas, 77030

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • University of California at Los Angeles

    Los Angeles, California, 90095

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53211

  • Univeristy of Minnesota

    Minneapolis, Minnesota, 55455

  • West Virginia University

    Morgantown, West Virginia, 26506-9162

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Mt. Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Oklahoma Medical Center

    Oklahoma City, Oklahoma, 73104

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Arizona Cancer Center

    Phoenix, Arizona, 85013

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Texas Transplant Institute

    San Antonio, Texas, 78229

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Stanford Hospital and Clinics

    Stanford, California, 94305

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794-7122

Other trials in United States

About this study

Official title: A Multi-Center, Phase III, Randomized Trial of RIC and Transplantation of (dUCB) Versus HLA-Haplo Related Bone Marrow for Patients With Hematologic Malignancies.(BMT CTN #1101)

Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare the effectiveness of two new types of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow donated from family members with only partially matched bone marrow; and, one that uses two partially matched cord blood units.

Read the detailed description

Reduced intensity conditioning (RIC) blood or marrow transplantation (BMT) has allowed older and less clinically fit patients to receive potentially curative treatment with allogeneic HCT for high risk or advanced hematological malignancies. Patients lacking an HLA-matched sibling may receive a graft from a suitably HLA-matched unrelated donor. However, up to a third of patients will not have an HLA-matched sibling or a suitably matched adult unrelated donor (i.e., no more than a mismatch at a single locus). Even when a suitably matched unrelated donor is identified, data from the National Marrow Donor Program (NMDP) indicate that a median of four months is required to complete searches that result in transplantation; thus, some number of patients succumb to their disease while awaiting identification and evaluation of a suitably matched adult unrelated donor.

Single or dual center studies have shown that partially HLA-mismatched related bone marrow (haplo-BM) and unrelated double umbilical cord blood (dUCB) are valuable sources of donor cells for RIC HCT, thus extending this treatment modality to patients who lack other donors. In order to study the reproducibility, and thus, the wider applicability of these two alternative donor strategies, The Blood and Marrow Transplantation Clinical Trials Network (BMT CTN) conducted two parallel multicenter prospective Phase II clinical trials. These two studies evaluated the safety and efficacy of related haplo-BM (BMT CTN 0603) and dUCB (BMT CTN 0604) transplantation after RIC. Both of these alternative donor approaches produced early results similar to that reported with unrelated donor, and even HLA-matched sibling, HCT. These data demonstrate not only the efficacy of both of these approaches, but also that both can be safely exported from the single center setting. Both haplo-BM and dUCB grafts can be obtained rapidly for greater than 90% of patients lacking an HLA-matched donor. This study will test the hypothesis that progression free survival at two years after RIC haplo-BM transplantation is similar to the progression free survival after RIC dUCB transplantation.

Being tested
Haploidentical Bone Marrow Transplant, Double Umbilical Cord Blood Transplant
Keywords
Haplo identical transplant, Cord blood transplant, Reduced intensity conditioning regimen, Lymphoma, Leukemia
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Burkitt Lymphoma, Lymphoma, Follicular, Hodgkin Disease, Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Haploidentical Bone Marrow TransplantBiological

    The conditioning regimen consists of:

    Fludarabine (Flu)30 mg/m2 IV Days -6, -5, -4, -3, -2 Cyclophosphamide (Cy) 14.5 mg/kg IV Days -6, -5 Total body irradiation (TBI) 200cGy Day -1

    The GVHD prophylaxis regimen consists of:

    Cy 50 mg/kg IV Days 3, 4 Tacrolimus (IV or PO) beginning Day 5 Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day 5 until Day 35

  • Double Umbilical Cord Blood TransplantBiological

    The preparative regimen consists of:

    Fludarabine 40 mg/m2 IV Days -6, -5, -4,-3, -2 Cyclophosphamide 50 mg/kg IV Day -6 Total Body Irradiation (TBI) 200 cGy Day -1 for patients who have received cytotoxic chemotherapy within the 3 months of enrollment or an autologous transplant within 24 months of enrollment or 300 cGy Day -1 for patients who have not received cytotoxic chemotherapy within the 3 months of enrollment and who have not received an autologous transplant within 24 months of enrollment.

    The GVHD prophylaxis regimen consists of:

    Cyclosporine beginning Day -3 with dose adjusted to maintain a trough level of 200-400 ng/mL.

    Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day -3 until Day 35

Study groups in NCT01597778
Study groupRoleWhat they receive
Haploidentical Bone Marrow TransplantExperimentalParticipants will receive haploidentical bone marrow transplant using a reduced intensity conditioning regimen.
Receives: Biological: Haploidentical Bone Marrow Transplant
Double Umbilical Cord Blood TransplantExperimentalParticipants will receive a double umbilical cord blood transplant using a reduced intensity conditioning regimen.
Receives: Biological: Double Umbilical Cord Blood Transplant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Progression Free Survival (PFS)

    The primary endpoint is PFS at 2 years post-randomization. Death or disease relapse/progression will be considered as events. The time to event is defined as the time interval from randomization to relapse/progression, to death or to last follow-up, whichever comes first. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of progressive lymphoma. Minimal residual disease will not be considered evidence of relapse, however, minimal residual disease that progresses will be considered as relapse and the date of relapse will be the date of detection of minimal residual disease that prompted an intervention by the treating physician. Finally, institution of any therapy to treat persistent, progressive or relapsed disease, including withdrawal of immunosuppressive therapy or DLI, will be considered evidence of relapse/progression regardless of whether the criteria described above are met.

    Measured: Year 2

Secondary outcomes (13)

  1. Percentage of Participants With PFS by Treatment Arms in Subgroups

    Participants' primary diagnosis was categorized into two large groups: leukemia versus lymphoma. Age was dichotomized into two large groups: age <= 59 versus age > 59. The Kaplan-Meier estimate for PFS at 2 years post-randomization are provided for each subgroup.

    Measured: Year 2

  2. Percentage of Participants With Neutrophil Recovery

    Neutrophil recovery is defined as achieving an absolute neutrophil count greater than or equal to 500/mm^3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil recovery.

    Measured: Day 56

  3. Percentage of Participants With Platelet Recovery

    Platelet recovery is defined by two different metrics as the first day of a sustained platelet count greater than 20,000/mm^3 or greater than 50,000/mm^3 with no platelet transfusions in the preceding seven days. The first day of the sustained platelet count will be designated the day of platelet engraftment.

    Measured: Day 100

  4. Participants With Primary Graft Failure

    Primary graft failure is defined as less than 5% donor chimerism on all measurements up to and including Day 56.

    Measured: Day 56

  5. Percentage of Participants With Secondary Graft Failure

    Secondary graft failure is defined as initial donor chimerism ≥ 5% declining to < 5% on subsequent measurements with time to secondary graft failure beginning at the first day of primary engraftment.

    Measured: Year 2

  6. Percentage of Participants With Acute Graft-versus-Host Disease (aGVHD)

    The cumulative incidences of grade II - IV and III - IV acute aGVHD will be determined.

    Measured: Day 180

  7. Percentage of Participants With Chronic Graft-versus-Host Disease (cGHVD)

    The cumulative incidence of cGVHD from the time of transplant will be determined. Data were collected directly from providers and chart review according to the recommendations of the NIH Consensus Conference.

    Measured: Year 2

  8. Percentage of Participants With Overall Survival

    Overall survival is defined as the time interval between date of randomization and death from any cause or for surviving patients, to last follow-up. The time interval between date of transplant and death from any cause or for surviving patients, to last follow-up are also analyzed.

    Measured: Year 2

  9. Percentage of Participants With Treatment-related Mortality (TRM)

    The cumulative incidence of TRM will be estimated, event for this endpoint is death without evidence of disease progression or recurrence.

    Measured: Day 100, Day 180, Year 1, and Year 2

  10. Percentage of Participants With Relapse/Progression

    Incidence of relapse/progression will be estimated using cumulative incidence function, treating death in remission as a competing risk. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of progressive lymphoma. When in doubt, the diagnosis of recurrent or progressive lymphoma should be documented by tissue biopsy. Minimal residual disease will not be considered evidence of relapse, however, minimal residual disease that progresses will be considered as relapse and the date of relapse will be the date of detection of minimal residual disease that prompted an intervention by the treating physician. Finally, institution of any therapy to treat persistent, progressive or relapsed disease, including withdrawal of immunosuppressive therapy or DLI, will be considered evidence of relapse/progression regardless of whether the criteria described above are met.

    Measured: Year 1, year 2

  11. Toxicities

    They are all Grade ≥ 3 toxicities based on NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.

    Measured: Day 28, Day 56, Day 180, 1 year, and 2 years

  12. Participants With Infections

    All Grade 2 and 3 infections will be reported. Grade 1 CMV infections through Day 56 will also be reported.

    Measured: Up to 2 years

  13. Hospital Admission and Length of Stay

    Total Time Alive and Not Hospitalized within 6 Months Post Randomization

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completion11 Sep 2020
  4. Study completion11 Sep 2020

Resources

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
None (open label)
Enrolment
368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01597778
Sponsor's protocol ID
BMTCTN1101
Other IDs
2U10HL069294-11, 5U24CA076518
Status last verified
Nov 2021
First submitted
10 May 2012
Last updated
1 Dec 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).

Publications

  • Eapen M, O'Donnell P, Brunstein CG, Wu J, Barowski K, Mendizabal A, Fuchs EJ. Mismatched related and unrelated donors for allogeneic hematopoietic cell transplantation for adults with hematologic malignancies. Biol Blood Marrow Transplant. 2014 Oct;20(10):1485-92. doi: 10.1016/j.bbmt.2014.05.015. Epub 2014 May 23.

    PubMed 24862638

  • Roth JA, Bensink ME, O'Donnell PV, Fuchs EJ, Eapen M, Ramsey SD. Design of a cost-effectiveness analysis alongside a randomized trial of transplantation using umbilical cord blood versus HLA-haploidentical related bone marrow in advanced hematologic cancer. J Comp Eff Res. 2014 Mar;3(2):135-44. doi: 10.2217/cer.13.95.

    PubMed 24645687

  • Zhang P, Logan B, Martens MJ. Covariate-Adjusted Group Sequential Comparisons of Survival Probabilities. Stat Med. 2025 Dec;44(28-30):e70339. doi: 10.1002/sim.70339.

    PubMed 41350757

  • Khanal M, Logan BR, Banerjee A, Fang X, Ahn KW. A Commensurate Prior Model With Random Effects for Survival and Competing Risk Outcomes to Accommodate Historical Controls. Pharm Stat. 2025 Jan-Feb;24(1):e2464. doi: 10.1002/pst.2464.

    PubMed 39846144

  • Ramsey SD, Bansal A, Li L, O'Donnell PV, Fuchs EJ, Brunstein CG, Eapen M, Thao V, Roth JA, Steuten LMG. Cost-Effectiveness of Unrelated Umbilical Cord Blood Transplantation versus HLA-Haploidentical Related Bone Marrow Transplantation: Evidence from BMT CTN 1101. Transplant Cell Ther. 2023 Jul;29(7):464.e1-464.e8. doi: 10.1016/j.jtct.2023.04.017. Epub 2023 Apr 27.

    PubMed 37120135

  • El Jurdi N, Martens MJ, Brunstein CG, O'Donnell P, Lee SJ, D'Souza A, Logan B, Hong S, Singh AK, Sandhu K, Shapiro RM, Horowitz MM, Hamilton BK. Health-Related Quality of Life in Double Umbilical Cord Blood versus Haploidentical Marrow Transplantation: A Quality of Life Analysis Report of BMT CTN 1101. Transplant Cell Ther. 2023 Jul;29(7):467.e1-467.e5. doi: 10.1016/j.jtct.2023.04.009. Epub 2023 Apr 22.

    PubMed 37088401

  • Brunstein CG, DeFor TE, Fuchs EJ, Karanes C, McGuirk JP, Rezvani AR, Eapen M, O'Donnell PV, Weisdorf DJ; Blood and Marrow Transplant Clinical Trials Network. Engraftment of Double Cord Blood Transplantation after Nonmyeloablative Conditioning with Escalated Total Body Irradiation Dosing to Facilitate Engraftment in Immunocompetent Patients. Transplant Cell Ther. 2021 Oct;27(10):879.e1-879.e3. doi: 10.1016/j.jtct.2021.07.006. Epub 2021 Jul 15.

    PubMed 34273598

  • Fuchs EJ, O'Donnell PV, Eapen M, Logan B, Antin JH, Dawson P, Devine S, Horowitz MM, Horwitz ME, Karanes C, Leifer E, Magenau JM, McGuirk JP, Morris LE, Rezvani AR, Jones RJ, Brunstein CG. Double unrelated umbilical cord blood vs HLA-haploidentical bone marrow transplantation: the BMT CTN 1101 trial. Blood. 2021 Jan 21;137(3):420-428. doi: 10.1182/blood.2020007535.

    PubMed 33475736

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Haploidentical Bone Marrow Transplant and Double Umbilical Cord Blood Transplant in people with Acute Lymphocytic Leukemia and Acute Myelogenous Leukemia, run by Medical College of Wisconsin at 39 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 18 inclusion and 10 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 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 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 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?

Yes. Results are posted in the registry (first posted 1 Dec 2021). 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?

Percentage of Participants With Progression Free Survival (PFS) (time frame: Year 2). 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 NCT01597778, which also lists 8 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 1 Dec 2021.

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