Acute Myelogenous LeukemiaPhase 1/2NCT00270881
Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies
A Phase 1/2 study testing Cord blood transplantation, TBI and cyclophosphamide in people with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia, run by Keio University at 1 site in Japan.
Trial summary
The primary purpose of this study is to evaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies including refractory acute leukemia. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
- What is being tested?
- Cord blood transplantation, TBI and cyclophosphamide
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2006to Jan 2011
- Phase
- Phase 1/2
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of acute leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome
- Lack of HLA-identical or 1 locus mismatched related donor
- Age over 20, and under 55
- Performance status 0 or 1
- No moderate or sever organ dysfunction (liver, kidney, heart, lungs)
- No anti-HLA antibody
- Informed consent was obtained
Who cannot join
- Uncontrollable diabetes
- Uncontrollable hypertension
- Active infection
- TPHA, HBs-Ag, HCV-Ab positive
- HTLV-I, HIV positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen
The primary purpose of this study is to evaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies including refractory acute leukemia. The transplant procedure was determined in detail according to the previously published report showing a high survival, so that the investigators could expect a similar result.
Read the detailed description
Although cord blood is considered as an alternative donor source for allogeneic hematopoietic stem cell transplantation, its procedure has yet to be standardized. Recently, a single institute result of cord blood transplantation for adult patients with hematologic malignancies have been reported by Takahashi et al (Blood 2004:104;3813-3820), in which the survival was significantly better than that of bone marrow transplantation from unrelated donor. The purpose of this study was to reevaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies using the same transplant procedures in a multi-institutional setting.
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome
- Being tested
- Cord blood transplantation, TBI, cyclophosphamide, cytarabine
- Keywords
- cord blood transplantation, myeloablative regimen, hematologic malignancies
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord blood transplantationProcedure or surgery
unrelated cord blood transplantation
TBIRadiation
Total body irradiation (TBI) 12Gy
cyclophosphamideDrug
cyclophosphamide 120mg/kg
cytarabineDrug
cytarabine 3g/m2x4
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-relapse mortality at 1 year
Measured: 1 year
Secondary outcomes (7)
Engraftment
Measured: day 56
Disease free survival
Measured: 1 year
Overall survival
Measured: 1 year
Incidence of acute and chronic graft-versus-host disease
Measured: day100 and 1 year
Incidence of infectious complication
Measured: 1year
Duration of hospitalization
Measured: 1 year
Immune reconstitution after transplantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous LeukemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takehiko Mori, M.D., Ph.D., Keio University
- Investigators
- Hisashi Sakamaki, M.D., Ph.D., Study chair, Tokyo Metropolitan Komagome Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270881
- Sponsor's protocol ID
- KSGCT-CB2005
- Status last verified
- Apr 2012
- First submitted
- 28 Dec 2005
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen
- ClinicalTrials.gov ID
- NCT00270881
- Acronym / sponsor ID
- KSGCT-CB2005
- Conditions
- Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome
- Keywords
- cord blood transplantation, myeloablative regimen, hematologic malignancies
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Keio UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 Dec 2005 (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 primary purpose of this study is to evaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies including refractory acute leukemia. The transplant procedure was determined in detail according to the previously published report showing a high survival, so that the investigators could expect a similar result.
Detailed description
Although cord blood is considered as an alternative donor source for allogeneic hematopoietic stem cell transplantation, its procedure has yet to be standardized. Recently, a single institute result of cord blood transplantation for adult patients with hematologic malignancies have been reported by Takahashi et al (Blood 2004:104;3813-3820), in which the survival was significantly better than that of bone marrow transplantation from unrelated donor. The purpose of this study was to reevaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies using the same transplant procedures in a multi-institutional setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of acute leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome
- Lack of HLA-identical or 1 locus mismatched related donor
- Age over 20, and under 55
- Performance status 0 or 1
- No moderate or sever organ dysfunction (liver, kidney, heart, lungs)
Key exclusion criteria (5 listed)
- Uncontrollable diabetes
- Uncontrollable hypertension
- Active infection
- TPHA, HBs-Ag, HCV-Ab positive
- HTLV-I, HIV positive
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 transplantationunrelated cord blood transplantation | Procedure or surgery | – |
| TBITotal body irradiation (TBI) 12Gy | Radiation | – |
| cyclophosphamidecyclophosphamide 120mg/kg | Drug | – |
| cytarabinecytarabine 3g/m2x4 | Drug | – |
Primary outcome
Non-relapse mortality at 1 year
Time frame: 1 year
7 secondary outcomes
Engraftment
Time frame: day 56
Disease free survival
Time frame: 1 year
Overall survival
Time frame: 1 year
Incidence of acute and chronic graft-versus-host disease
Time frame: day100 and 1 year
Incidence of infectious complication
Time frame: 1year
Duration of hospitalization
Time frame: 1 year
Immune reconstitution after transplantation
Time frame: 1 year
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 6 Apr 2012.
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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.
Hisashi Sakamaki, M.D., Ph.D. study chair
Tokyo Metropolitan Komagome Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cord blood transplantation, TBI and cyclophosphamide in people with Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia, run by Keio University at 1 site in Japan.
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 7 inclusion and 5 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 6 Apr 2012. 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 Japan. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Non-relapse mortality at 1 year (time frame: 1 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 6 Apr 2012.