ClinicalTrials.gg
CompletedNCT00897260Updated Jan 26, 2018

Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders

An interventional study of Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders and Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders in Hematological Malignancy and Bone Marrow Failure Syndrome, sponsored by University of British Columbia. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2018-01-26.

Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 80 studies in Hematologic Neoplasms with a site in Canada — 15 open to participants now, 26 under way, 5 of them phase 3. Hematologic Neoplasms · Canada.

Enrollment
56th of 68
27 · median 84
Started
2009
with 7 others
No phase
13 of 80
2 open now
Registered
10th of 80
by date

Among the 80 studies in Hematologic Neoplasms with a site in Canada, this one is the 56th largest by enrollment of the 68 interventional ones that give a count, is one of 8 that started in 2009, is one of 13 with no phase, and was the 10th registered.

Hematologic Neoplasms

1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.

Browse Hematologic Neoplasms studies →

Open to participants now

15 of the 80 studies in Hematologic Neoplasms with a site in Canada are open now. Recruiting first, the newest first:

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All 15 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 313 Hematologic Neoplasms studies recruiting now, 208 (66%) set no upper age limit and 78 (25%) stop at 75 or younger; 80 take children under 18; 34 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Hematological Malignancy
  • Bone Marrow Failure Syndrome

Keywords

  • Unrelated Umbilical Cord Blood Transplant
  • Multiple cord blood
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients must have a 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.
  • 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)
  • performance status ≥ 80 (Appendix 10.2)

Exclusion criteria

Exclusion Criteria:

  • Active infection
  • Pregnancy
  • Significant psychiatric disorder
  • Progressive disease
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    1

    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

Interventions

  • DrugUmbilical 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. 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

  • RadiationUmbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders

    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

  • ProcedureUmbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
06

What researchers measure

Primary outcomes

  1. To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.

    Time frame: 1 year

Secondary outcomes

  1. 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

  2. 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

  3. To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis

    Time frame: 1 year

  4. 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

07

Study locations

1 site
  • Vancouver General Hospital, Leukemia/BMT Program of BC
    Vancouver, British Columbia V5Z 1M9, Canada
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2009, a primary completion of Jan 2013 and a completion of Jan 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2009
First posted
May 12, 2009
Start
May 2009
Primary completionActual
Jan 9, 2013
CompletionActual
Jan 9, 2013
Last update
Jan 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00897260
Responsible party
Donna E. Hogge (Principal Investigator, University of British Columbia) — Principal investigator
First posted
May 12, 2009
Start date
May 2009
Primary completion
Jan 9, 2013
Completion
Jan 9, 2013
Last update
Jan 26, 2018

Study contacts

Donna Hogge
principal investigator · University of British Columbia - Vancouver Coastal Health Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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