Hematological MalignancyNCT00897260
Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders
A study testing Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders in people with Hematological Malignancy and Bone Marrow Failure Syndrome, run by University of British Columbia at 1 site in Canada.
Trial summary
To determine the time to and rate of hematologic engraftment following unrelated umbilical cord blood transplantation in adults with one or two cord blood units using total body irradiation and fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematological Malignancy, Bone Marrow Failure Syndrome
- What is being tested?
- Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to 9 Jan 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have a histologically confirmed diagnosis at The Vancouver General Hospital or the BCCA-Vancouver.
- Eligible patients will have one of the following underlying diseases:
- High risk acute lymphoblastic leukemia (ALL) in first complete remission, with high risk being defined by the presence of t(4;11), t(9;22) or t(1;19) or patients presenting with extreme hyperleukocytosis (WBC >100x109/L) or failure to achieve a complete remission after standard induction therapy.
- Acute myeloid leukemia (AML) in first complete remission with high risk cytogenetics or failure to achieve complete remission after standard induction therapy. ALL or AML in second or subsequent remission
- Myelofibrosis with myeloid metaplasia.
- Chronic myeloid leukemia in chronic (failed interferon and/or Gleevec) or accelerated phase.
Show all 16Show fewer
- Myelodysplastic syndrome with IPSS risk category >Int-1
- Aplastic anemia
- Non-Hodgkin's lymphoma, chronic lymphocytic leukemia or Hodgkin's disease in relapse or second or subsequent remission.
- Multiple Myeloma
- No active central nervous system (CNS) disease.
- No 9/10 or better HLA antigen matched related donor or VUD available.
- The patient's condition precludes waiting to search and find a VUD in the Unrelated Donor Registries
- Acceptance of standard blood product support
- Adequate organ function as defined by current Leukemia/BMT Program of BC standards (Appendix 10.1)
- Karnofsky performance status ≥ 80 (Appendix 10.2)
Who cannot join
- Active infection
- Pregnancy
- Significant psychiatric disorder
- Progressive disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital, Leukemia/BMT Program of BC
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Umbilical Cord Blood Transplantation as Treatment of Adult Patients With Hematologic Disorders
To determine the time to and rate of hematologic engraftment following unrelated umbilical cord blood transplantation in adults with one or two cord blood units using total body irradiation and fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis.
- Being tested
- Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
- Keywords
- Unrelated Umbilical Cord Blood Transplant, Multiple cord blood
- Medical subject headings
- Hematologic Neoplasms, Bone Marrow Failure Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic DisordersDrug
To determine the time to and rate of hematologic engraftment following unrelated umbilical cord blood transplantation in adults with one or two cord blood units using total body irradiation and fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis.
DRUG/DOSE DAYS -9 -8, -7 -6 -5 -4 -3 -2 -1 Total Body Irradiation 150 cGy per treatment (1350cGy total) 2x 2x 2x 2x 1x
- Fludarabine 40mg/m2 10:00am (After TBI) over 60 minutes x x x x Umbilical cord blood infusion (minimum of 24hrs after Flu infusion) x
- Fludarabine dose adjustment: 70ml/min: decrease dose by Creatinine Clearance 20% Fludarabine dosing will be based on the 40% adjusted ideal body weight.
UCB Infusion
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic DisordersRadiation
DRUG/DOSE DAYS -9 -8, -7 -6 -5 -4 -3 -2 -1 Total Body Irradiation 150 cGy per treatment (1350cGy total) 2x 2x 2x 2x 1x
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic DisordersProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders; Radiation: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders; Procedure: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.
Measured: 1 year
Secondary outcomes (4)
To determine the 100-day treatment related mortality (TRM), complete remission rate and the 2-year progression free and overall survival rate for patients under going this treatment.
Measured: 100 days
To determine the incidence of grades II-IV and grades III-IV acute GVHD and incidence of limited and extensive chronic GVHD.
Measured: 1 year
To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis
Measured: 1 year
To determine rate of hematologic engraftment following umbilical cord blood transplantation with 1-2 cord blood units using total body irradiation & fludarabine as transplant conditioning regimen & cyclosporine/MMF as graft-vs-host disease prophylaxis
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 posted12 May 2009 (estimated)
- Study startMay 2009
- Primary completion9 Jan 2013
- Study completion9 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna E. Hogge, University of British Columbia
- Investigators
- Donna Hogge, Principal investigator, University of British Columbia - Vancouver Coastal Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897260
- Sponsor's protocol ID
- H08-02813
- Status last verified
- Jan 2018
- First submitted
- 8 May 2009
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Blood Transplantation as Treatment of Adult Patients With Hematologic Disorders
- ClinicalTrials.gov ID
- NCT00897260
- Acronym / sponsor ID
- H08-02813
- Keywords
- Unrelated Umbilical Cord Blood Transplant, Multiple cord blood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- 9 Jan 2013 (actual)
- Study completion
- 9 Jan 2013 (actual)
- First posted
- 12 May 2009 (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.
To determine the time to and rate of hematologic engraftment following unrelated umbilical cord blood transplantation in adults with one or two cord blood units using total body irradiation and fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders, Radiation: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders, Procedure: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have a histologically confirmed diagnosis at The Vancouver General Hospital or the BCCA-Vancouver.
- High risk acute lymphoblastic leukemia (ALL) in first complete remission, with high risk being defined by the presence of t(4;11), t(9;22) or t(1;19) or patients presenting with extreme hyperleukocytosis (WBC >100x109/L) or failure to achieve a complete remission after standard induction therapy.
- Acute myeloid leukemia (AML) in first complete remission with high risk cytogenetics or failure to achieve complete remission after standard induction therapy. ALL or AML in second or subsequent remission
- Myelofibrosis with myeloid metaplasia.
- Chronic myeloid leukemia in chronic (failed interferon and/or Gleevec) or accelerated phase.
Key exclusion criteria (4 listed)
- Active infection
- Pregnancy
- Significant psychiatric disorder
- Progressive disease
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 |
|---|---|---|
| Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic DisordersTo determine the time to and rate of hematologic engraftment following unrelated umbilical cord blood transplantation in adults with one or two cord blood units using total body irradiation and fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis. DRUG/DOSE DAYS -9 -8, -7 -6 -5 -4 -3 -2 -1 Total Body Irradiation 150 cGy per treatment (1350cGy total) 2x 2x 2x 2x 1x * Fludarabine 40mg/m2 10:00am (After TBI) over 60 minutes x x x x Umbilical cord blood infusion (minimum of 24hrs after Flu infusion) x * Fludarabine dose adjustment: 70ml/min: decrease dose by Creatinine Clearance 20% Fludarabine dosing will be based on the 40% adjusted ideal body weight. UCB Infusion | Drug | 1 |
| Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic DisordersDRUG/DOSE DAYS -9 -8, -7 -6 -5 -4 -3 -2 -1 Total Body Irradiation 150 cGy per treatment (1350cGy total) 2x 2x 2x 2x 1x | Radiation | 1 |
| Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders | Procedure or surgery | 1 |
Primary outcome
To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.
Time frame: 1 year
4 secondary outcomes
To determine the 100-day treatment related mortality (TRM), complete remission rate and the 2-year progression free and overall survival rate for patients under going this treatment.
Time frame: 100 days
To determine the incidence of grades II-IV and grades III-IV acute GVHD and incidence of limited and extensive chronic GVHD.
Time frame: 1 year
To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis
Time frame: 1 year
To determine rate of hematologic engraftment following umbilical cord blood transplantation with 1-2 cord blood units using total body irradiation & fludarabine as transplant conditioning regimen & cyclosporine/MMF as graft-vs-host disease prophylaxis
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 26 Jan 2018.
- Related InfoLink provided by the sponsor.
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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.
Donna Hogge principal investigator
University of British Columbia - Vancouver Coastal Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders in people with Hematological Malignancy and Bone Marrow Failure Syndrome, run by University of British Columbia at 1 site in Canada.
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 16 inclusion and 4 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 26 Jan 2018. 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 Canada. 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.
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?
To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy. (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 26 Jan 2018.