NCT04217356Active, not recruiting
Study of Stem Cell Transplant vs. Non-Transplant Therapies in High-Risk Myelofibrosis
A Patient Preferences-Controlled Study of Allogeneic Hematopoietic Cell Transplantation Versus Best Available Non-Transplant Therapies in Patients With High-Risk Myelofibrosis (ALLO-BAT Study)
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
The purpose of this research study is to see how effective hematopoietic stem cell transplantation (HCT) is compared to best available non-transplant therapies (BAT) in patients with high risk myelofibrosis. This will be done by asking participants to choose the treatment that they prefer to receive (HCT or BAT) and then comparing the outcomes of the participants in both treatment groups.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 2 Jan 2020
- Start date
- 5 Aug 2020
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT04217356
What you commit to
- Study type: Observational
- Planned participants: 90
- From 5 Aug 2020 to the primary completion date, 31 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of transformation to blast phase or acute myeloid leukemia
- Received allogeneic stem cell transplant for myeloproliferative neoplasm
- History of active malignancy in the previous 2 years, except basal cell carcinoma or squamous cell carcinoma of skin or stage 0 cervical cancer
- History of active malignancy in the previous 2 years, except basal cell carcinoma or squamous cell carcinoma of skin or stage 0 cervical cancer
Other illness
- For patients already on ruxolitinib at study entry, and meet the criteria of ruxolitinib failure
- Presence of an active uncontrolled infection
- Myocardial infarction in the preceding 3 months
- Active hepatitis A, B or C
- Known human immunodeficiency virus (HIV) positive
- Any psychiatric illness or social circumstances or significant co-morbid conditions that will prevent patient from proceeding to allogeneic hematopoietic cell transplantation.
- Meet the criteria of ruxolitinib failure
- Presence of an active uncontrolled infection
- Myocardial infarction in the preceding 3 months
- Active hepatitis A, B or C
- Known HIV positive
- Any psychiatric illness or social circumstances or significant co-morbid conditions that will prevent patient from proceeding to allogeneic hematopoietic cell transplantation.
Other
- Recruitment Part:
- Blasts in peripheral blood or bone marrow ≥10%
- Pregnant or breastfeeding women
- Study Arm Allocation:
- Blasts in peripheral blood or bone marrow ≥10%
- Pregnant or breastfeeding women
- Time between registration and allocation of study arm \>24 weeks
Who the study is looking for
- Recruitment Part:
- Documented diagnosis of pre-fibrotic primary myelofibrosis (pre-fibrotic PMF), overt PMF, post-polycythemia MF (PPV-MF) or post-essential thrombocythemia MF (PET-MF) confirmed by bone marrow biopsy
- Have been tested or have results available for phenotypic driver mutations (JAK2/CALR/MPL) and high molecular risk (HMR) mutations using a broad myeloid malignancies targeted gene panel.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Able to provide informed consent
- Adequate organ function
- Donor search initiated or patient is agreeable to donor search
- Meet the definition/criteria for high-risk myelofibrosis
- Study Arm Allocation:
- Grade of fibrosis on bone marrow biopsy available according to World Health Organization (WHO) criteria
- Results available for phenotypic driver mutations (JAK2/CALR/MPL) and targeted sequencing results using a broad myeloid malignancy panel with a minimal requirement to include results on High molecular risk (HMR) mutations such as ASXL1/EZH2/IDH1/IDH2/SRSF2/U2AF1/TP53
- ECOG performance status 0-2
- Adequate organ function
- Information on donor search and donor type available
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tom Baker Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Nova Scotia Health Authority Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.