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
Clinical Trials Information System (CTIS) 2007-000806-64
Protocol serial number BLT004973
Sponsor Barts and the London NHS Trust (UK)
Funder Barts and the London NHS Trust (UK)
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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-low-intensity-stem-cell-transplant-after-chemotherapy-acute-myeloid-leukaemia-high-risk-myelodysplastic-syndrome-MUNICH

Contact information

Dr Jamie Cavenagh
Scientific

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

Study information

Primary study designInterventional
Study designOpen phase II study
Secondary study designNon randomised study
Study type Participant information sheet
Scientific titleA 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 acronymSequential treatment with cytoreductive therapy & transplant
Study objectivesIs 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) studiedMyeloid malignancies
InterventionReduced 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 typeBiological/Vaccine
PhasePhase II
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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.

Completion date01/04/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration93
Total final enrolment54
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2007
Date of final enrolment01/04/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

St Bartholomew's Hospital
London
EC1A 7BE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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.

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