Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation

Acute Myeloid Leukaemia Clinical Trial

— SCRAMBLE  

Official title:

Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02189824
• Other study ID #: SCTL141501
• Secondary ID: PG1061252
• Status: Recruiting
• Phase: Phase 1
• First received: July 11, 2014
• Last updated: October 29, 2015
• Start date: August 2014

Study information

• Verified date: October 2015
• Source: University of Sydney
• Contact: Emily Blyth
• Email: emily.blyth[@]sydney.edu.au
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration (TGA)
• Study type: Interventional

Clinical Trial Summary

A phase 1 study of infusion of partially HLA matched unrelated donor blood or marrow cells (microtransplantation) following consolidation chemotherapy in patients with AML that are not suitable for allogenic stem cell transplantation.

Description:

To determine the safety and tolerability of co-administration of partially HLA antigen matched unrelated donor cryopreserved donor lymphocytes (microtransplantation) with chemotherapy for patients with high risk acute myeloid leukaemia ineligible or unsuitable for high dose chemotherapy and stem cell transplantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Newly diagnosed AML not considered suitable for allogenic stem cell transplant on the basis of age or co-morbidities

2. Complete morphological remission following 1-2 cycles of induction chemotherapy consisting of an anthracycline/cytosine arabinoside combination

3. Availability of cryopreserved donor stem cells or bone marrow with appropriate HLA matching

4. Adequate hepatic and renal function

5. Estimated life expectancy of at least 6 months

6. Patient has given informed consent or in the event of a patient not able to give informed consent, consent has been given according to hospital procedures in force at the time of trial

Exclusion Criteria:

1. Patient not in morphological remission following 2 cycles of induction chemotherapy

2. Use of fludarabine or other purine analogue during remission induction or use of any major immunosuppressive medication or any other immunomodulatory agent including thalidomide, lenalidomide, or azacitidine immediately prior to concurrent with administration of chemotherapy for AML or during or in the 3 months after administration of partially HLA matched 3rd party cells

3. Absence of a cryopreserved donor stem cell or bone marrow product with appropriate matching

4. Presence of significant hepatic, renal or other major organ dysfunction

5. Uncontrolled infection or bleeding prior to commencement of consolidation chemotherapy

6. Privately insured in or outpatient on the day the consent is signed and the days that cryopreserved partially HLA matched donor cells are infused

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukaemia
• Leukemia, Myeloid, Acute

Intervention

Biological:
• Partially HLA-matched unrelated donor cells

Locations

Country	Name	City	State
Australia	Westmead Hospital Department of Haematology	Westmead, Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
University of Sydney	Melbourne Health, Royal Brisbane and Women's Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes		60 days	Yes
Secondary	Duration of post chemotherapy cytopenias		60 days	No
Secondary	Remission rate		12 months	No
Secondary	Duration of complete remission		12 months	No