Cord Blood Stem Cell TransplantationPhase 2NCT00514579
Adult Double Cord Blood Transplant Study
A Phase 2 study testing Cord blood transplantation in people with Cord Blood Stem Cell Transplantation and Hematologic Malignancies, run by Center for International Blood and Marrow Transplant Research at 10 sites in United States.
Trial summary
The hypothesis of the study is double unit umbilical cord blood transplantation in adults will be associated with a one year survival rate of at least 40%. Read more about this study
- Who is it for?
- Ages 22 to 50 years
- Conditions the study is for
- Cord Blood Stem Cell Transplantation, Hematologic Malignancies
- What is being tested?
- Cord blood transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2007to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 22 - 50 years
- Patients will have one of the following hematological malignancies:
- Acute myelogenous leukemia (AML): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
- Acute lymphoblastic leukemia (ALL): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
- Acute undifferentiated leukemia (AUL) or biphenotypic leukemia: CR1 or CR2
- Myelodysplastic Syndrome (MDS) with one of the following: Low and Intermediate-1 International Prognostic Scoring System (IPSS) score with Life-threatening neutropenia or thrombocytopenia; or Platelet transfusion dependence Intermediate-2 or High IPSS score Therapy-related disease: patient with history of chemotherapy and current evidence of MDS
- Patients with adequate organ function and performance status criteria
- Two Suitable Umbilical Cord Blood Units: a cryopreserved dose of at least 1.5 x 107 TNC/kg. If the unit contains red cells at time of cryopreservation, the cryopreserved dose must be at least 2.0 x 107 TNC/kg. Each unit must be at least 4/6 HLA-A and B antigen, and DRB1 allele matched with the recipient. Each unit must be at least 3/6 HLA-A, B DRB1 antigen matched to each other.
Who cannot join
- Patient with suitable related donor
- AML, ALL, AUL, biphenotypic leukemia beyond CR2
- AML evolved from myelofibrosis
- Any acute leukemia with:
- Morphologic relapse or persistent disease in the BM
- Active extra-medullary leukemia including active CNS leukemia
Show all 15Show fewer
- Requiring greater than two cycles of chemotherapy to obtain present remission status
- Bone marrow aplasia (defined as BM cellularity < 5% at transplant work-up)
- MDS with 10% or greater bone marrow blasts at pre-transplant workup
- Prior autologous or allogeneic HSC transplant at any time
- Prior radiation therapy rendering patient ineligible for TBI
- Any uncontrolled infection at time of study enrollment
- Seropositive or NAT positive for HIV or HTLV1
- Females who are pregnant or breast feeding
- Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Blood and Marrow Transplant Program at Northside Hospital
Atlanta, Georgia, 30342
Case Western Reserve University
Cleveland, Ohio, 44106
Ohio State University Medical Center
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
University of California at Los Angeles
Los Angeles, California, 90095
University of Wisconsin-Madison
Madison, Wisconsin, 53792
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Oklahoma
Oklahoma City, Oklahoma, 73104
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase II Multicenter Trial of Myeloablative Double Unit Umbilical Cord Blood Transplantation (UCBT) in Adults With Hematologic Malignancy
The hypothesis of the study is double unit umbilical cord blood transplantation in adults will be associated with a one year survival rate of at least 40%.
- Being tested
- Cord blood transplantation
- Keywords
- Cord Blood Stem Cell Transplantation, Hematologic Malignancies, Leukemia, Myelodysplastic Syndrome
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord blood transplantationProcedure or surgery
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
| Study group | Role | What they receive |
|---|---|---|
| Myeloablative double unit UCBT | Other | Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation Receives: Procedure: Cord blood transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure overall survival of double unit UCBT in adult patients with hematologic malignancies
Measured: One year
Secondary outcomes (9)
Measure incidence of donor-derived neutrophil and platelet recovery
Measured: 100 Days
Measure contribution of each unit to initial and sustained engraftment
Measured: 2 years
Measure incidence and severity of acute graft-versus-host disease
Measured: 100 Days
Measure incidence and severity of chronic GVHD
Measured: 1 year
Measure incidence of transplant-related mortality
Measured: 6 months
Measure incidence of malignant relapse
Measured: 2 years
Measure incidence of serious infectious complications
Measured: 1 year
Measure incidence of immune reconstitution
Measured: 2 years
Measure probability of overall and disease-free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cord Blood Stem Cell TransplantationStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Juliet Barker, MBBS, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514579
- Sponsor's protocol ID
- 05-DCB
- Status last verified
- Mar 2014
- First submitted
- 8 Aug 2007
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Trial of Myeloablative Double Unit Umbilical Cord Blood Transplantation (UCBT) in Adults With Hematologic Malignancy
- ClinicalTrials.gov ID
- NCT00514579
- Acronym / sponsor ID
- 05-DCB
- Keywords
- Cord Blood Stem Cell Transplantation, Hematologic Malignancies, Leukemia, Myelodysplastic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Center for International Blood and Marrow Transplant ResearchResearch network
- Study start
- Aug 2007
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of the study is double unit umbilical cord blood transplantation in adults will be associated with a one year survival rate of at least 40%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myeloablative double unit UCBT | Other | Procedure: Cord blood transplantationMyeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 22 - 50 years
- Patients will have one of the following hematological malignancies:
- Patients with adequate organ function and performance status criteria
- Two Suitable Umbilical Cord Blood Units: a cryopreserved dose of at least 1.5 x 107 TNC/kg. If the unit contains red cells at time of cryopreservation, the cryopreserved dose must be at least 2.0 x 107 TNC/kg. Each unit must be at least 4/6 HLA-A and B antigen, and DRB1 allele matched with the recipient. Each unit must be at least 3/6 HLA-A, B DRB1 antigen matched to each other.
Key exclusion criteria (15 listed)
- Patient with suitable related donor
- AML, ALL, AUL, biphenotypic leukemia beyond CR2
- AML evolved from myelofibrosis
- Any acute leukemia with:
- Bone marrow aplasia (defined as BM cellularity < 5% at transplant work-up)
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 |
|---|---|---|
| Cord blood transplantationMyeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation | Procedure or surgery | Myeloablative double unit UCBT |
Primary outcome
Measure overall survival of double unit UCBT in adult patients with hematologic malignancies
Time frame: One year
9 secondary outcomes
Measure incidence of donor-derived neutrophil and platelet recovery
Time frame: 100 Days
Measure contribution of each unit to initial and sustained engraftment
Time frame: 2 years
Measure incidence and severity of acute graft-versus-host disease
Time frame: 100 Days
Measure incidence and severity of chronic GVHD
Time frame: 1 year
Measure incidence of transplant-related mortality
Time frame: 6 months
Measure incidence of malignant relapse
Time frame: 2 years
Measure incidence of serious infectious complications
Time frame: 1 year
Measure incidence of immune reconstitution
Time frame: 2 years
Measure probability of overall and disease-free survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
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A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
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Recruiting
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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.
Juliet Barker, MBBS principal investigator
Memorial Sloan Kettering Cancer Center
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 Cord blood transplantation in people with Cord Blood Stem Cell Transplantation and Hematologic Malignancies, run by Center for International Blood and Marrow Transplant Research 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?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure overall survival of double unit UCBT in adult patients with hematologic malignancies (time frame: One year). 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 10 Mar 2014.