Condition category
Cancer
Date applied
09/02/2007
Date assigned
27/03/2007
Last edited
08/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Jamie Cavenagh

ORCID ID

Contact details

Department of Haematology
Level One Pathology Block
St. Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BLT004973

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

Acronym

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

Ethics approval received from the East London and The City Committee 1 on the 23rd July 2007 (ref: 07/Q0603/65).

Study design

Open phase II study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Myeloid malignancies

Intervention

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

Other

Phase

Phase II

Drug names

Primary outcome measures

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

01/04/2007

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

93

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

01/04/2007

Recruitment end date

01/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Haematology, Level One Pathology Block
London
EC1A 7BE
United Kingdom

Sponsor information

Organisation

Barts and the London NHS Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Barts and the London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes