Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Dr Jamie Cavenagh


Contact details

Department of Haematology
Level One Pathology Block
St. Bartholomew's Hospital
West Smithfield
United Kingdom

Additional identifiers

EudraCT number

2007-000806-64 number

Protocol/serial number


Study information

Scientific title

A phase II trial of sequential treatment with cytoreductive therapy and reduced intensity conditioning allogeneic stem cell transplantation for relapsed/ refractory acute myeloid leukemia, high risk myelodysplasia, or other high risk myeloid malignancies


Sequential treatment with cytoreductive therapy & transplant

Study hypothesis

Is it safer and more effective, in treating high risk myeloid malignancies, to immediately follow chemotherapy with allogeneic haemopoietic stem cell transplantation than to treat in two distinct phases, with a break to determine remission status?

Ethics approval

East London and The City Committee 1, 23/07/2007, ref: 07/Q0603/65

Study design

Open phase II study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Myeloid malignancies


Reduced intensity conditioning allogeneic stem cell transplantation: standard practice calls for remission (or near remission) in patients treated with chemotherapy before progression to transplantation. This occurs in less than 50% of cases. In this study, all patients will proceed straight to transplantation.

Intervention type



Phase II

Drug names

Primary outcome measure

Overall Survival (OS) at 1, 2 and 4 years

Secondary outcome measures

1. Event Free Survival (EFS) at 1, 2 and 4 years
2. Treatment Related Mortality (TRM) at d100, 1 and 2 years and cause of mortality
3. Incidence and Grade of Acute Graft versus Host Disease (GVHD)
4. Incidence and Grade of Chronic GVHD
5. Time to Engraftment*
6. Full Split Chimerism at Days 30, 60, 100 and 1 year
7. Request for Donor Lymphocyte Infusion (DLI) (Mixed chimerism vs disease persistence)
8. Incidence of opportunistic infections
9. Duration of hospitalisation
*Date of Neutrophil Engraftment is defined as the first of two consecutive days with a neutrophil count exceeding 500/μL. Date of platelet recovery is considered the first of three consecutive days with an unsupported platelet count exceeding 20 x 109 / L.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Diagnosis of histologically documented acute myeloid leukemia (AML) (any WHO type), with primary induction failure, or at relapse where the patient is not a candidate or does not wish to proceed to a myeloablative transplant. Also, histologically / cytogenetically documented diagnosis of Myelodysplasia (MDS) (IPSS Int. 2, HR) , or other high risk Myeloid Malignancy where the patient is not a candidate or does not wish to proceed to a myeloablative transplant.
2. All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures must have resolved to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) (Version 3.0) Grade < 2 (with the exception of chemotherapy−induced alopecia). Surgery must have occurred at least 21 days prior to initiation of treatment.
3. Age must be greater than 18 years.
4. Last dose of antineoplastic therapy must be more than 14 days from starting treatment, except for hydroxyurea or Low Dose Ara C which may have been administered up to 24 hours prior to first study drug administration for leukoreduction.
5. Eastern Cooperative Oncology Group (ECOG) performance status must be 0, 1, or 2.
6. Life expectancy of at least 2 months.
7. Pregnancy test (females of childbearing potential) Negative.
8. Signed informed consent indicating that they are aware of the neoplastic nature of their disease and have been informed of the procedures to be followed, alternatives, potential benefits, side effects, risks, and discomforts.
9. Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Concurrent therapy with any other investigational agent.
2. Pregnant or breastfeeding women. All at-risk female subjects must have a negative pregnancy test within 10 days prior to the start treatment.
3. Clinically significant cardiac disease (New York Heart Association, Class III or IV).
4. Dementia or altered mental status that would prohibit informed consent.
5. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this study.
6. Current malignancies at other sites, with the exception of adequately treated cone−biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

St Bartholomew's Hospital
United Kingdom

Sponsor information


Barts and the London NHS Trust (UK)

Sponsor details

The Joint Research Office
3rd Floor Rutland House
42−46 New Road
E1 2AX
United Kingdom

Sponsor type




Funder type


Funder name

Barts and the London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)


Publication list

Publication citations

Additional files

Editorial Notes

01/03/2019: Basic results link added.