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
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