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
| ISRCTN | ISRCTN32336114 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32336114 |
| EudraCT/CTIS number | 2007-000806-64 |
| Secondary identifying numbers | BLT004973 |
- Submission date
- 09/02/2007
- Registration date
- 27/03/2007
- Last edited
- 31/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Jamie Cavenagh
Scientific
Scientific
Department of Haematology, Level One Pathology Block
St. Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
Study information
| Study design | Open phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | Sequential treatment with cytoreductive therapy & transplant |
| Study objectives | 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(s) | East London and The City Committee 1, 23/07/2007, ref: 07/Q0603/65 |
| Health condition(s) or problem(s) studied | 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 | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/04/2007 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 93 |
| Total final enrolment | 54 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Bartholomew's Hospital
London
EC1A 7BE
United Kingdom
EC1A 7BE
United Kingdom
Sponsor information
Barts and the London NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
The Joint Research Office
3rd Floor Rutland House
42−46 New Road
Whitechapel
London
E1 2AX
England
United Kingdom
"ROR" |
https://ror.org/00b31g692 |
|---|
Funders
Funder type
Government
Barts and the London NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Plain English results | 31/03/2022 | No | Yes |
Editorial Notes
31/03/2022: Plain English results and total final enrolment added.
01/03/2019: Basic results link added.
