Hematologic MalignancyPhase 2NCT02385955
Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients
A Phase 2 study testing Myeloablative double unit cord blood transplantation in people with Hematologic Malignancy, run by Seoul National University Hospital.
Trial summary
This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI), cyclophosphamide, and cytarabine, or (2)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Myeloablative double unit cord blood transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hematologic malignancies requiring hematopoietic stem cell transplantation: (1) high risk acute myeloid leukemia in remission, (2) high risk acute lymphoblastic leukemia in remission, or (3) IPSS intermediate-2, high, or transfusion-dependent myelodysplastic syndrome
- Patients who have suitable cord blood units for dUCBT
- Patients with ECOG performance status 0-1
- Patients with adequate organ function: lung, kidney, liver, heart, etc.
- Informed consent
Who cannot join
- Patients who can receive hematopoietic stem cell transplantation from HLA-matched sibling or unrelated donors
- Patients who have anti-HLA antibodies
- Patients with any evidence of central nervous system (CNS) involvement of disease
- Patients with uncontrolled diabetes
- Patients with uncontrolled hypertension
- Patients with any evidence of active infection
Show all 12Show fewer
- Positive for human immunodeficiency virus (HIV)
- Previous history of other malignancy within 5 years (Basal cell carcinoma of skin, cervical carcinoma in situ, and differentiated thyroid carcinoma with curative resection are permitted.)
- Women who are pregnant or breastfeeding
- Patients with previous history of allogeneic stem cell transplantation
- Patients with major psychotic disorder or drug/alcohol abuser
- Inappropriate patients according to the investigators' opinion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Multicenter Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients With Hematologic Malignancies
This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.
- Conditions
- Hematologic Malignancy
- Being tested
- Myeloablative double unit cord blood transplantation
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myeloablative double unit cord blood transplantationProcedure or surgery
Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI, 12Gy), followed by cyclophosphamide (60 mg/kg/day on day -3 and -2) and cytarabine (3 g/m2 every 12 hours on day -5 and -4), or (2) thiotepa (5 mg/kg/day on day -7 and -6), busulfan (3.2 mg/kg/day on day -5, -4, and -3), and fludarabine (50 mg/m2/day on day -5, -4, and -3).
| Study group | Role | What they receive |
|---|---|---|
| Myeloablative dUCBT | Experimental | Myeloablative conditioning with (1) TBI, cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine, followed by double unit umbilical cord blood transplant Receives: Procedure: Myeloablative double unit cord blood transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years
Secondary outcomes (7)
Progression-free survival
Measured: 2 years
Time to relapse or progression
Measured: 2 years
Time to engraftment
Measured: 2 years
Acute graft-versus-host disease
Measured: 2 years
Chronic graft-versus-host disease
Measured: 2 years
Non-relapse mortality
Measured: 2 years
Other transplant-related serious adverse events
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 posted11 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Society of Blood and Marrow Transplantation
- Responsible party
- Principal investigator, Sung-Soo Yoon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385955
- Sponsor's protocol ID
- KSBMT200809
- Status last verified
- Mar 2015
- First submitted
- 20 Jan 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Takahashi S, Ooi J, Tomonari A, Konuma T, Tsukada N, Oiwa-Monna M, Fukuno K, Uchiyama M, Takasugi K, Iseki T, Tojo A, Yamaguchi T, Asano S. Comparative single-institute analysis of cord blood transplantation from unrelated donors with bone marrow or peripheral blood stem-cell transplants from related donors in adult patients with hematologic malignancies after myeloablative conditioning regimen. Blood. 2007 Feb 1;109(3):1322-30. doi: 10.1182/blood-2006-04-020172. Epub 2006 Oct 12.
PubMed 17038536Mori T, Tanaka M, Kobayashi T, Ohashi K, Fujisawa S, Yokota A, Fujita H, Nakaseko C, Sakura T, Nannya Y, Takahashi S, Kanamori H, Kanda Y, Sakamaki H, Okamoto S; Kanto Study Group for Cell Therapy. Prospective multicenter study of single-unit cord blood transplantation with myeloablative conditioning for adult patients with high-risk hematologic malignancies. Biol Blood Marrow Transplant. 2013 Mar;19(3):486-91. doi: 10.1016/j.bbmt.2012.12.007. Epub 2012 Dec 16.
PubMed 23253560Sanz J, Boluda JC, Martin C, Gonzalez M, Ferra C, Serrano D, de Heredia CD, Barrenetxea C, Martinez AM, Solano C, Sanz MA, Sanz GF; Grupo Espanol de Trasplante Hematopoyetico y Terapia Celular (GETH). Single-unit umbilical cord blood transplantation from unrelated donors in patients with hematological malignancy using busulfan, thiotepa, fludarabine and ATG as myeloablative conditioning regimen. Bone Marrow Transplant. 2012 Oct;47(10):1287-93. doi: 10.1038/bmt.2012.13. Epub 2012 Feb 13.
PubMed 22327127Ruggeri A, Sanz G, Bittencourt H, Sanz J, Rambaldi A, Volt F, Yakoub-Agha I, Ribera JM, Mannone L, Sierra J, Mohty M, Solano C, Nabhan S, Arcese W, Gluckman E, Labopin M, Rocha V; Eurocord and Acute Leukemia Working Party of European Blood and Marrow Transplant Group. Comparison of outcomes after single or double cord blood transplantation in adults with acute leukemia using different types of myeloablative conditioning regimen, a retrospective study on behalf of Eurocord and the Acute Leukemia Working Party of EBMT. Leukemia. 2014 Apr;28(4):779-86. doi: 10.1038/leu.2013.259. Epub 2013 Sep 5.
PubMed 24005245
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02385955
- Acronym / sponsor ID
- KSBMT200809
- Conditions
- Hematologic Malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- The Korean Society of Blood and Marrow Transplantation
- Study start
- Apr 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 11 Mar 2015 (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.
This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myeloablative dUCBT | Experimental | Procedure: Myeloablative double unit cord blood transplantationMyeloablative conditioning with (1) TBI, cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine, followed by double unit umbilical cord blood transplant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with hematologic malignancies requiring hematopoietic stem cell transplantation: (1) high risk acute myeloid leukemia in remission, (2) high risk acute lymphoblastic leukemia in remission, or (3) IPSS intermediate-2, high, or transfusion-dependent myelodysplastic syndrome
- Patients who have suitable cord blood units for dUCBT
- Patients with ECOG performance status 0-1
- Patients with adequate organ function: lung, kidney, liver, heart, etc.
- Informed consent
Key exclusion criteria (12 listed)
- Patients who can receive hematopoietic stem cell transplantation from HLA-matched sibling or unrelated donors
- Patients who have anti-HLA antibodies
- Patients with any evidence of central nervous system (CNS) involvement of disease
- Patients with uncontrolled diabetes
- Patients with uncontrolled hypertension
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 |
|---|---|---|
| Myeloablative double unit cord blood transplantationTwo myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI, 12Gy), followed by cyclophosphamide (60 mg/kg/day on day -3 and -2) and cytarabine (3 g/m2 every 12 hours on day -5 and -4), or (2) thiotepa (5 mg/kg/day on day -7 and -6), busulfan (3.2 mg/kg/day on day -5, -4, and -3), and fludarabine (50 mg/m2/day on day -5, -4, and -3). | Procedure or surgery | Myeloablative dUCBT |
Primary outcome
Overall survival
Time frame: 2 years
7 secondary outcomes
Progression-free survival
Time frame: 2 years
Time to relapse or progression
Time frame: 2 years
Time to engraftment
Time frame: 2 years
Acute graft-versus-host disease
Time frame: 2 years
Chronic graft-versus-host disease
Time frame: 2 years
Non-relapse mortality
Time frame: 2 years
Other transplant-related serious adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Background: PubMed 17038536Takahashi S, Ooi J, Tomonari A, Konuma T, Tsukada N, Oiwa-Monna M, Fukuno K, Uchiyama M, Takasugi K, Iseki T, Tojo A, Yamaguchi T, Asano S. Comparative single-institute analysis of cord blood transplantation from unrelated donors with bone marrow or peripheral blood stem-cell transplants from related donors in adult patients with hematologic malignancies after myeloablative conditioning regimen. Blood. 2007 Feb 1;109(3):1322-30. doi: 10.1182/blood-2006-04-020172. Epub 2006 Oct 12.
- Background: PubMed 23253560Mori T, Tanaka M, Kobayashi T, Ohashi K, Fujisawa S, Yokota A, Fujita H, Nakaseko C, Sakura T, Nannya Y, Takahashi S, Kanamori H, Kanda Y, Sakamaki H, Okamoto S; Kanto Study Group for Cell Therapy. Prospective multicenter study of single-unit cord blood transplantation with myeloablative conditioning for adult patients with high-risk hematologic malignancies. Biol Blood Marrow Transplant. 2013 Mar;19(3):486-91. doi: 10.1016/j.bbmt.2012.12.007. Epub 2012 Dec 16.
- Background: PubMed 22327127Sanz J, Boluda JC, Martin C, Gonzalez M, Ferra C, Serrano D, de Heredia CD, Barrenetxea C, Martinez AM, Solano C, Sanz MA, Sanz GF; Grupo Espanol de Trasplante Hematopoyetico y Terapia Celular (GETH). Single-unit umbilical cord blood transplantation from unrelated donors in patients with hematological malignancy using busulfan, thiotepa, fludarabine and ATG as myeloablative conditioning regimen. Bone Marrow Transplant. 2012 Oct;47(10):1287-93. doi: 10.1038/bmt.2012.13. Epub 2012 Feb 13.
- Background: PubMed 24005245Ruggeri A, Sanz G, Bittencourt H, Sanz J, Rambaldi A, Volt F, Yakoub-Agha I, Ribera JM, Mannone L, Sierra J, Mohty M, Solano C, Nabhan S, Arcese W, Gluckman E, Labopin M, Rocha V; Eurocord and Acute Leukemia Working Party of European Blood and Marrow Transplant Group. Comparison of outcomes after single or double cord blood transplantation in adults with acute leukemia using different types of myeloablative conditioning regimen, a retrospective study on behalf of Eurocord and the Acute Leukemia Working Party of EBMT. Leukemia. 2014 Apr;28(4):779-86. doi: 10.1038/leu.2013.259. Epub 2013 Sep 5.
Related trials for Hematologic Malignancy
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Myeloablative double unit cord blood transplantation in people with Hematologic Malignancy, run by Seoul National University Hospital.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung-Soo Yoon, MD, PhD (+82-2-2072-3079, ssysmc@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). 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 NCT02385955, which also lists 4 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 11 Mar 2015.