Register a trial

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06607367




Registration number
NCT06607367
Ethics application status
Date submitted
15/09/2024
Date registered
23/09/2024

Titles & IDs
Public title
REscuing Bone Marrow Function in Patients with AplaStic AnaEmia and Bone Marrow FaiLure Post AllogEneiC Transplantation 2
Scientific title
REscuing Bone Marrow Function in Patients with AplaStic AnaEmia and Bone Marrow FaiLure Post AllogEneiC Transplantation 2
Secondary ID [1] 0 0
2024.231
Universal Trial Number (UTN)
Trial acronym
RESELECT2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor Graft Function 0 0
Aplastic Anemia Idiopathic 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia
Blood 0 0 0 0
Anaemia
Blood 0 0 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ruxolitinib (JAKAVI®)
Treatment: Drugs - Eltrombopag (Revolade®)

Experimental: Ruxolitinib and Eltrombopag - Ruxolitinib at a dose of 10mg BD and Eltrombopag at a dose of 50mg Dose adjustments may be required based on lack of efficacy, or thrombocytopenia may occur as per the study protocol .


Treatment: Drugs: Ruxolitinib (JAKAVI®)
Initial starting dose will be 10mg BD

Treatment: Drugs: Eltrombopag (Revolade®)
Initial starting dose will be 50mg daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete Response at 12 weeks
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Grade 2 or Higher Non-Haematologic Toxicity
Timepoint [2] 0 0
From study enrolment to study completion (maximum of 1 year per subject)

Eligibility
Key inclusion criteria
Patient must meet ALL of the following:

1. Poor Graft function OR Relapsed/refractory AA

1. 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;
2. Relapsed /Refractory AA defined as: Relapse after stem cell transplant OR relapsed post/refractory to 1st line immunosuppression without an unrelated donor identified.
2. Age =18
3. ECOG performance status 0-1
4. Life expectancy greater than 6 months
5. Patient's written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active Grade 3-4 acute GVHD
2. Relapsed or progressive disease on screening bone marrow biopsy or most recent PET imaging.
3. Active second malignancy currently requiring treatment
4. Human Immuno-deficiency Virus (HIV) infection.
5. Any coexisting medical or psychological condition that would preclude participation in the required study procedures.
6. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Ritchie
Address 0 0
Country 0 0
Phone 0 0
+61393427000
Fax 0 0
Email 0 0
david.ritchie@mh.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will not be shared. Aggregate patient data and final results will be presented in the final report


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06607367