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Leukemia, Myeloid, AcutePhase 2NCT00916045

Pilot Study of Unrelated Cord Blood Transplantation

A Phase 2 study testing Thiotepa, Fludarabine and Intravenous busulphan in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by King's College Hospital NHS Trust at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the safety and feasibility of unrelated double and single cord blood transplantation in patients with haematological malignancies using reduced-intensity or myeloablative conditioning regimens. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Thiotepa, Fludarabine and Intravenous busulphan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2009to Mar 2012
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged under 35 years and greater than 18 years
  • Absence of HLA compatible related donor.
  • Need for an urgent transplantation or absence of HLA-compatible VUD after searching the international registries.
  • Patients with a HLA-compatible VUD but whose donor is considered by the transplantation centre as unsuitable will also be eligible.
  • Availability of suitable UD-UCB unit/s.
  • Informed consent.

Who cannot join

  • Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor or 10/10 unrelated bone marrow donor
  • ECOG performance status worse than 2
  • Cardiac insufficiency requiring treatment, symptomatic coronary artery disease or LVEF less than 40%.
  • Hepatic disease, with total bilirubin above 20umol/l or AST > 3 times upper limit of normal.
  • Severe hypoxaemia, pO2 < 70 mm Hg, with decreased DLCO < 70% of predicted; or mild hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 60% of predicted.
  • Impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight).
Show all 41Show fewer
  • Patients who have received previous treatment with Thymoglobulin®
  • HIV or HTLV positive patients.
  • Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
  • Life expectancy severely limited by diseases other than the disease indication for transplant
  • Serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection
  • Serious psychiatric/ psychological disorders
  • Absence of /inability to provide informed consent
  • Serious diseases that prevent treatments with chemotherapy
  • Myelofibrosis
  • Inclusion criteria: reduced-intensity conditioning regimen (For both FluMel \& FluCyTBI regimens):
  • Age under 70 years and older than 18 years
  • Absence of HLA compatible related donor.
  • Need for an urgent transplantation or absence of HLA-compatible VUD after searching the international registries.
  • Patients with a HLA-compatible VUD but whose donor is considered by the transplantation centre as unsuitable will also be eligible.
  • Availability of suitable UD-UCB unit/s.
  • Informed consent.
  • Exclusion Criteria: reduced-intensity conditioning regimen (For both FluMel \& FluCyTBI regimens):
  • Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor or 10/10 unrelated bone marrow donor
  • ECOG performance status worse than 2
  • Cardiac insufficiency requiring treatment, symptomatic coronary artery disease or LVEF less than 35%.
  • Hepatic disease, with total bilirubin greater than 2 times upper limit of normal or AST > 5 times upper limit of normal.
  • Severe hypoxaemia, pO2 < 70 mm Hg, with decreased DLCO < 50% of predicted; or mild hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 50% of predicted.
  • Impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight).
  • Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI).
  • Patients who have received previous treatment with Thymoglobulin®
  • HIV or HTLV positive patients.
  • Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
  • Life expectancy severely limited by diseases other than the disease indication for transplant
  • Serious concurrent uncontrolled infection e.g. active tuberculosis, mycoses or viral infection
  • Serious psychiatric/ psychological disorders
  • Absence of /inability to provide informed consent
  • Within 6 months of prior myeloablative transplant.
  • Patients with acute leukaemia in morphological relapse/ persistent/ progressive disease
  • Intermediate or high grade NHL, mantle cell NHL and Hodgkin's disease that is refractory or progressive on salvage therapy.
  • Myelofibrosis

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • King's College Hosptial NHS Foundation Trust

    London, SE5 9RS

Other trials in United Kingdom

About this study

Official title: Pilot Study of Unrelated Cord Blood Transplantation in Patients With Poor Risk Haematological Malignancies

The purpose of this study is to determine the safety and feasibility of unrelated double and single cord blood transplantation in patients with haematological malignancies using reduced-intensity or myeloablative conditioning regimens.

Being tested
Thiotepa, Fludarabine, Intravenous busulphan, Thymoglobulin, Ciclosporin
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThiotepaDrug

  • FludarabineDrug

  • Intravenous busulphanDrug

    Also called Busilvex

  • ThymoglobulinDrug

  • CiclosporinDrug

  • Mycophenolate mofetil (MMF)Drug

  • FludarabineDrug

  • CyclophosphamideDrug

  • RadiotherapyRadiation

  • ThymoglobulinDrug

  • CiclosporinDrug

  • Mycophenolate mofetil (MMF)Drug

  • FludarabineDrug

  • MelphalanDrug

  • ThymoglobulinDrug

  • CiclosporinDrug

  • Mycophenolate mofetil (MMF)Drug

Study groups in NCT00916045
Study groupRoleWhat they receive
Myeloblative conditioning regimenOtherNot described
Receives: Drug: Thiotepa; Drug: Fludarabine; Drug: Intravenous busulphan; Drug: Thymoglobulin; Drug: Ciclosporin; Drug: Mycophenolate mofetil (MMF)
Reduced intensity conditioning regimen - FluCyTBIOtherNot described
Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Radiation: Radiotherapy; Drug: Thymoglobulin; Drug: Ciclosporin; Drug: Mycophenolate mofetil (MMF)
Reduced intensity conditioning regimen - FluMelOtherNot described
Receives: Drug: Fludarabine; Drug: Melphalan; Drug: Thymoglobulin; Drug: Ciclosporin; Drug: Mycophenolate mofetil (MMF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment related mortality at day 100

    Measured: Day 100

Secondary outcomes (15)

  1. Disease free survival at one year post-transplant for each cohort

    Measured: 1 year

  2. Chimerism

    Measured: Days 14 (myeloblative conditioning only), 28, 56, 100 and months 6 and 12

  3. Incidence of neutrophil engraftment by day 42

    Measured: Days 14, 28 and 42

  4. Incidence of platelet engraftment by 6 months

    Measured: Days 14, 28, 56, 100 and month 6

  5. Incidence of grade II-IV and III-IV acute GVHD

    Measured: Days 28, 56, 100 and months 6, 9, 12, 18 and 24

  6. Incidence of chronic GVHD during the first year

    Measured: Day 100 and months 6 and 12

  7. One year overall survival for each treatment cohort

    Measured: 1 year

  8. Incidence of systemic infections

    Measured: Twice a week pre-transplant to day 100 then weekly or as clinically indicated

  9. Incidence of CMV, adenovirus and EBV activation

    Measured: Twice a week pre-transplant to day 100 then weekly or as clinically indicated

  10. Immune reconstitution

    Measured: Days 14, 28, 56, 100 and months 6, 9, 12, 18 and 24

  11. Dynamics of EBV infection and immunity following cord blood transplantation

    Measured: Days 14, 28, 56, 100 and months 6, 9 and 12

  12. The development (if any) of transplant associated post transplant lymphoproliferative disease (PTLD)

    Measured: Days 14, 28, 56, 100 and months 6, 9 and 12

  13. Identify any possible predictive markers for patients most at risk of PTLD development

    Measured: Days 14, 28, 56, 100 and months 6, 9 and 12

  14. Quality of life

    Measured: Pre-transplant and months 6, 12, 18 and 24

  15. Incidence of one year relapse or disease progression for each treatment cohort

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2012
  4. Study completionMar 2012

Why it stopped: Recruitment issues

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00916045
Sponsor's protocol ID
07CC12
Other IDs
REC - 07/H0808/193, EudraCT - 2007-001657-26
Status last verified
Mar 2012
First submitted
5 Jun 2009
Last updated
11 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Thiotepa, Fludarabine and Intravenous busulphan in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by King's College Hospital NHS Trust at 1 site in United Kingdom.

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 6 inclusion and 41 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: stopped early, as of the sponsor's last update on 11 Feb 2015. 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 United Kingdom. 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 was stopped early (reason given: Recruitment issues). Results are not available in the source record.

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?

Treatment related mortality at day 100 (time frame: Day 100). 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 NCT00916045.

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 Feb 2015.

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