Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromePhase 2NCT01093586
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
A Phase 2 study testing double-unit umbilical cord blood transplantation, cytogenetic analysis and bone marrow aspiration in people with Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome and Adult Acute Lymphoblastic Leukemia in Remission, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Read more about this study
- Who is it for?
- Ages 12 to 64 years
- Conditions the study is for
- Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Megakaryoblastic Leukemia (M7)
- What is being tested?
- double-unit umbilical cord blood transplantation, cytogenetic analysis and bone marrow aspiration
- 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
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2015
- 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 12 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients will be diagnosed with one of the following hematological malignancies: acute myelogenous leukemia (AML), acute lymphoblastic leukemia, non-Hodgkin's lymphoma, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and myeloproliferative and lymphoproliferative disorders
- AML--First remission (CR1) with high risk features including a known prior diagnosis of myelodysplasia (MDS); therapy related AML; white cell count at presentation > 100,000; presence of extramedullary leukemia at diagnosis; unfavorable AML subtype (M0, M5-M7); poor cytogenetic markers (abnormalities of chromosome 5, 7 or 8, 11q23, Philadelphia chromosome, complex karyotype)
- AML--Second remission (CR2) or subsequent remission
- AML--Relapse/Persistent Disease with < 20% bone marrow blasts
- ALL--First remission (CR1) at high risk for relapse as defined by: B cell ALL white blood cell count (WBC) at presentation > 30,000 (T cell ALL WBC > 100,000); presence of high-risk cytogenetic abnormality such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23), t(8;14)
- ALL--Second remission (CR2) or subsequent remission
Show all 24Show fewer
- ALL--Relapse/Persistent Disease with < 20% bone marrow blasts
- Non-Hodgkin Lymphoma--Induction failure or relapse and sensitive to most recent chemotherapy
- MDS--Low or Intermediate-1 International Prognostic Scoring System (IPSS) score with: life-threatening cytopenia(s); and/or red cell or platelet transfusion dependence
- MDS--ANC < 500, recurrent infections, PRBC transfusions > 2 units/month, poor risk cytogenetics, platelet transfusion dependence
- MDS--Intermediate-2 or High IPSS score
- CML--Chronic phase I (CP1) and resistant to or intolerant of tyrosine kinase inhibitors (i.e. imatinib, dasatinib, etc.)
- CML--CP2 or subsequent chronic phase, including chronic phase achieved after induction therapy for blast crisis
- Myeloproliferative and lymphoproliferative disorders--eligibility to be determined by a consensus of the physicians on the Case Comprehensive Cancer Center Leukemia/Lymphoma Multidisciplinary Committee
- Myeloproliferative and lymphoproliferative disorders--must have evidence of disease acceleration to be a candidate for umbilical cord blood transplant; myeloproliferative disorders eligible for transplant include chronic myelomonocytic leukemia (CMML) with high IPSS score and myelofibrosis
- Myeloproliferative and lymphoproliferative disorders--potential lymphoproliferative disorders eligible for transplant include chronic lymphocytic leukemia, prolymphocytic leukemia, and large granular lymphocytic leukemia
- Good performance status: Karnofsky >= 70 % or ECOG 0-1
- Calculated creatinine clearance >= 60 mL/min, or measured creatinine clearance >= 60 mL/min (by 24-hour urine collection) if creatinine >= 1.5 or history of renal dysfunction
- Hepatic Transaminases < 4 x upper limit normal (ULN); total bilirubin < 2.5 mg/dL, unless the patient has a history of benign congenital hyperbilirubinemia (Gilbert's syndrome)
- Normal cardiac function by echocardiogram or radionuclide scan, (left ventricular ejection fraction > 45%); if the left ventricular ejection fraction is between 40-50%, clearance by an adult cardiologist is required
- Pulmonary function tests demonstrating FEV1 > 60% of predicted for age
- Adults must have a DLCOva > 60% normal
- For patients unable to complete pulmonary function tests clearance by an adult pulmonologist is required
- Patients will be eligible for the clinical trial under the following conditions: they do NOT have an HLA-A/B/DR B1 identical RELATED bone marrow donor; they do NOT have a 6/6 HLA-identical matched unrelated adult donor; OR a matched related donor transplant is not in the best interest of the patient (i.e., patient's condition precludes waiting on the donor, too much time to prepare the donor, the donor is ineligible due to medical reasons, or in the case of high risk disease a related donor is not appropriated (syngeneic transplant); the decision must be agreed upon by the consensus of physicians on the Case Comprehensive Cancer Center Leukemia/Lymphoma Multidisciplinary Committee; OR their condition precludes waiting to search and find a donor in the National Marrow Donor Registry
Who cannot join
- Female patients who are pregnant or breast-feeding
- HIV or HTLV-1 positivity
- Any leukemia with a morphologic relapse or persistent disease in the BM with >= 20% blasts (cytogenetic relapse without morphologic evidence of relapse, or cytogenetic persistent disease is acceptable)
- Active extramedullary leukemia, including CNS disease
- Prior hematopoietic stem cell transplant (autologous or allogeneic)
- Uncontrolled infection
- Patient has an identical related bone marrow donor or a 6/6 HLA-identical matched unrelated donor
- Any patient who is unable to provide informed consent or comply with the requirements of the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies
RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell transplant works in treating patients with hematologic malignancies.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish the day +180 overall survival after a myeloablative unrelated double unit UCBT in a single institution setting.
SECONDARY OBJECTIVES:
- To determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies, who are undergoing myeloablative chemotherapy followed by infusion of double unit UCBT.
- To determine the contribution of each umbilical cord unit to immune reconstitution with a focus on both initial (day +21 BM, and +28 PB) and sustained engraftment (day +100 BM; PB at +14, +21, +28, +35, +42, +60, +100, +180, +1 and 2 years).
- To determine the probability of overall survival and disease free survival at one and two years.
- To describe the incidence of disease recurrence at one and two years in patients post UCBT.
- To describe the incidence of acute GVHD and chronic GVHD at 100 days and at one year, respectively.
- To determine the incidence of day 100 and 180 treatment related mortality.
- To determine the incidence of serious infectious complications in the first year after transplant.
- To determine the incidence of donor-derived neutrophil and platelet recovery.
- To determine the incidence of secondary lymphoproliferative diseases following transplantation with umbilical cord blood.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive oral busulfan every 6 hours on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1.
TRANSPLANTATION: Patients undergo double-unit umbilical cord blood allogeneic stem cell transplantation on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally every 8 hours on days -3 to 45. After completion of study treatment, patients are followed periodically.
- Conditions
- Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b)
- Being tested
- double-unit umbilical cord blood transplantation, cytogenetic analysis, bone marrow aspiration, fluorescence in situ hybridization, busulfan
- Medical subject headings
- Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Congenital Abnormalities, Leukemia, Erythroblastic, Acute, Lymphoma, Extranodal NK-T-Cell, Blast Crisis, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double-unit umbilical cord blood transplantationProcedure or surgery
Undergo transplantation
cytogenetic analysisOther
Correlative studies
bone marrow aspirationProcedure or surgery
Correlative studies
fluorescence in situ hybridizationOther
Also called fluorescence in situ hybridization (FISH)
Correlative studies
busulfanDrug
Also called BSF, BU, Misulfan, Mitosan
Given orally
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
Given IV
anti-thymocyte globulinDrug
Also called ATG, ATGAM, lymphocyte immune globulin, Thymoglobulin
Given IV
Also called A-MethaPred, Depo-Medrol, Medrol, MePRDL
Given IV
cyclosporineDrug
Also called 27-400, ciclosporin, cyclosporin, cyclosporin A
Given IV
Also called Cellcept, MMF
Given orally or IV
flow cytometryOther
Correlative studies
allogeneic hematopoietic stem cell transplantationProcedure or surgery
Undergo transplantation
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. Receives: Procedure: double-unit umbilical cord blood transplantation; Other: cytogenetic analysis; Procedure: bone marrow aspiration; Other: fluorescence in situ hybridization; Drug: busulfan; Drug: cyclophosphamide; Drug: anti-thymocyte globulin; Drug: methylprednisolone; Drug: cyclosporine; Drug: mycophenolate mofetil; Other: flow cytometry; Procedure: allogeneic hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Number of participants alive at 180 days post engraftment.
Measured: On day +180
Secondary outcomes (14)
Hematologic Engraftment
Number of participants that were able to complete engraftment by day 42.
Measured: On day +42
Overall Survival
Number of participants that were alive.
Measured: At 1 year
Overall Survival
Number of participants that were alive.
Measured: At 2 years
Disease Free
Number of participants that were disease free
Measured: At 1 year
Disease Free
Number of participants that were disease free
Measured: At 2 years
Recurrence or Relapse
Number of subjects that had disease recurrence
Measured: one year in patients post UCBT
Recurrence or Relapse
Number of subjects that had disease recurrence
Measured: two years post transplant
Transplant Related Mortality
Number of subjects that died because of transplant
Measured: On day 100 post transplant
Transplant Related Mortality
Number of subjects that died because of transplant
Measured: On day 180 post transplant
Occurrence of Serious Infections
Number of participants that had infections
Measured: 1 year
Immune Reconstitution
Immunodificency panel to see recovery of immune system. Number of participants that recovered.
Measured: Periodically for 2 years
Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0
Number of participants that experienced toxicity related to the transplant
Measured: by day +42
Incidence of Acute Graft-versus-host Disease (GVHD)
Number of participants that had acute GVHD
Measured: At 100 days
Incidence of Chronic GVHD
Number of participants that have chronic GVHD. Chronic GVHD will be diagnosed and graded on clinical and histological criteria from the Center for International Blood and Marrow Transplant Research (CIBMTR)
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startSep 2007
- Primary completionDec 2015
- Study completionDec 2015
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 Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenda Cooper, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093586
- Sponsor's protocol ID
- CASE3Z07
- Other IDs
- NCI-2009-01319, CASE3Z07
- Status last verified
- Jan 2019
- First submitted
- 24 Mar 2010
- Last updated
- 23 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT01093586
- Acronym / sponsor ID
- CASE3Z07
- Conditions
- Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Posted 4 Jan 2019
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 before a donor umbilical cord blood transplant (UCBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell transplant works in treating patients with hematologic malignancies.
Detailed description
PRIMARY OBJECTIVES:
- To establish the day +180 overall survival after a myeloablative unrelated double unit UCBT in a single institution setting.
SECONDARY OBJECTIVES:
- To determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies, who are undergoing myeloablative chemotherapy followed by infusion of double unit UCBT.
- To determine the contribution of each umbilical cord unit to immune reconstitution with a focus on both initial (day +21 BM, and +28 PB) and sustained engraftment (day +100 BM; PB at +14, +21, +28, +35, +42, +60, +100, +180, +1 and 2 years).
- To determine the probability of overall survival and disease free survival at one and two years.
- To describe the incidence of disease recurrence at one and two years in patients post UCBT.
- To describe the incidence of acute GVHD and chronic GVHD at 100 days and at one year, respectively.
- To determine the incidence of day 100 and 180 treatment related mortality.
- To determine the incidence of serious infectious complications in the first year after transplant.
- To determine the incidence of donor-derived neutrophil and platelet recovery.
- To determine the incidence of secondary lymphoproliferative diseases following transplantation with umbilical cord blood.
OUTLINE:
PREPARATIVE REGIMEN: Patients receive oral busulfan every 6 hours on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1.
TRANSPLANTATION: Patients undergo double-unit umbilical cord blood allogeneic stem cell transplantation on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally every 8 hours on days -3 to 45. After completion of study treatment, patients are followed periodically.
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 | Procedure: double-unit umbilical cord blood transplantation, Other: cytogenetic analysis, Procedure: bone marrow aspiration, Other: fluorescence in situ hybridization, Drug: busulfan, Drug: cyclophosphamide, Drug: anti-thymocyte globulin, Drug: methylprednisolone, Drug: cyclosporine, Drug: mycophenolate mofetil, Other: flow cytometry, Procedure: allogeneic hematopoietic stem cell transplantationPREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45. |
Who may qualify
- Ages
- 12 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (24 listed)
- Patients will be diagnosed with one of the following hematological malignancies: acute myelogenous leukemia (AML), acute lymphoblastic leukemia, non-Hodgkin's lymphoma, myelodysplastic syndrome (MDS), chronic myelogenous leukemia (CML), and myeloproliferative and lymphoproliferative disorders
- AML--First remission (CR1) with high risk features including a known prior diagnosis of myelodysplasia (MDS); therapy related AML; white cell count at presentation > 100,000; presence of extramedullary leukemia at diagnosis; unfavorable AML subtype (M0, M5-M7); poor cytogenetic markers (abnormalities of chromosome 5, 7 or 8, 11q23, Philadelphia chromosome, complex karyotype)
- AML--Second remission (CR2) or subsequent remission
- AML--Relapse/Persistent Disease with < 20% bone marrow blasts
- ALL--First remission (CR1) at high risk for relapse as defined by: B cell ALL white blood cell count (WBC) at presentation > 30,000 (T cell ALL WBC > 100,000); presence of high-risk cytogenetic abnormality such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23), t(8;14)
Key exclusion criteria (8 listed)
- Female patients who are pregnant or breast-feeding
- HIV or HTLV-1 positivity
- Any leukemia with a morphologic relapse or persistent disease in the BM with >= 20% blasts (cytogenetic relapse without morphologic evidence of relapse, or cytogenetic persistent disease is acceptable)
- Active extramedullary leukemia, including CNS disease
- Prior hematopoietic stem cell transplant (autologous or allogeneic)
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 |
|---|---|---|
| double-unit umbilical cord blood transplantationUndergo transplantation | Procedure or surgery | Arm I |
| cytogenetic analysisCorrelative studies | Other | Arm I |
| bone marrow aspirationCorrelative studies | Procedure or surgery | Arm I |
| fluorescence in situ hybridizationAlso: fluorescence in situ hybridization (FISH)Correlative studies | Other | Arm I |
| busulfanAlso: BSF, BU, Misulfan, MitosanGiven orally | Drug | Arm I |
| cyclophosphamideAlso: CPM, CTX, Cytoxan, EndoxanGiven IV | Drug | Arm I |
| anti-thymocyte globulinAlso: ATG, ATGAM, lymphocyte immune globulin, ThymoglobulinGiven IV | Drug | Arm I |
| methylprednisoloneAlso: A-MethaPred, Depo-Medrol, Medrol, MePRDLGiven IV | Drug | Arm I |
| cyclosporineAlso: 27-400, ciclosporin, cyclosporin, cyclosporin AGiven IV | Drug | Arm I |
| mycophenolate mofetilAlso: Cellcept, MMFGiven orally or IV | Drug | Arm I |
| flow cytometryCorrelative studies | Other | Arm I |
| allogeneic hematopoietic stem cell transplantationUndergo transplantation | Procedure or surgery | Arm I |
Primary outcome
Overall Survival
Time frame: On day +180
Number of participants alive at 180 days post engraftment.
14 secondary outcomes
Hematologic Engraftment
Time frame: On day +42
Overall Survival
Time frame: At 1 year
Overall Survival
Time frame: At 2 years
Disease Free
Time frame: At 1 year
Disease Free
Time frame: At 2 years
Recurrence or Relapse
Time frame: one year in patients post UCBT
Recurrence or Relapse
Time frame: two years post transplant
Transplant Related Mortality
Time frame: On day 100 post transplant
Transplant Related Mortality
Time frame: On day 180 post transplant
Occurrence of Serious Infections
Time frame: 1 year
Immune Reconstitution
Time frame: Periodically for 2 years
Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0
Time frame: by day +42
Incidence of Acute Graft-versus-host Disease (GVHD)
Time frame: At 100 days
Incidence of Chronic GVHD
Time frame: At 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- 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.
Brenda Cooper, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing double-unit umbilical cord blood transplantation, cytogenetic analysis and bone marrow aspiration in people with Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome and Adult Acute Lymphoblastic Leukemia in Remission, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 8 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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 4 Jan 2019). 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?
Overall Survival (time frame: On day +180). 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 23 Jan 2019.