Status:
NOT_YET_RECRUITING
REscuing Bone Marrow Function in Patients with AplaStic AnaEmia and Bone Marrow FaiLure Post AllogEneiC Transplantation 2
Lead Sponsor:
Melbourne Health
Conditions:
Poor Graft Function
Aplastic Anemia Idiopathic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Allogeneic stem cell transplantation involves the transplanting of donor blood stem cells into a recipient, this is performed mainly for the treatment of blood cancers. The bone marrow is the organ th...
Detailed Description
Study Overview: This is a, multi-centre, single active arm with historic control arm, phase I/II study that will assess the safety and efficacy of ruxolitinib and eltrombopag in patients with relapse...
Eligibility Criteria
Inclusion
- Patient must meet ALL of the following:
- Poor Graft function OR Relapsed/refractory AA
- Poor Graft Function defined as follows:≥95% donor chimerism at last reading OR ≥95% CD3 negative chimerism; ≥2 Lineage cytopenias defined as:
- Thrombocytopenia:
- 30x109 /L from D40-D60 OR
- 50 x10 9/L from D60 onwards; Neutropenia requiring filgrastim support at any time post D40; Hb less than 80g/L;
- Relapsed /Refractory AA defined as: Relapse after stem cell transplant OR relapsed post/refractory to 1st line immunosuppression without an unrelated donor identified.
- Age ≥18
- ECOG performance status 0-1
- Life expectancy greater than 6 months
- Patient's written informed consent
Exclusion
- Active Grade 3-4 acute GVHD
- Relapsed or progressive disease on screening bone marrow biopsy or most recent PET imaging.
- Active second malignancy currently requiring treatment
- Human Immuno-deficiency Virus (HIV) infection.
- Any coexisting medical or psychological condition that would preclude participation in the required study procedures.
- Female patients who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
Key Trial Info
Start Date :
October 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06607367
Start Date
October 30 2024
End Date
October 30 2026
Last Update
September 23 2024
Active Locations (1)
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1
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050