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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukaemia
• Intervention / Treatment: Biological: Partially HLA-matched unrelated donor cells

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Emily Blyth; Email: emily.blyth@sydney.edu.au

Study Locations

• Australia
  • New South Wales
    • Westmead, Sydney, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital Department of Haematology
      • Contact: Emily Blyth; Phone Number: +61 2 9845 6274; Email: emily.blyth@sydney.edu.au
      • Principal Investigator: David Gottlieb
      • Sub-Investigator: Emily Blyth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infusion of partially matched unrelated donor cells	Biological: Partially HLA-matched unrelated donor cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes	60 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of post chemotherapy cytopenias	60 days
Remission rate	12 months
Duration of complete remission	12 months

Collaborators and Investigators

• Sponsor: University of Sydney
• Collaborators: Melbourne Health; Royal Brisbane and Women's Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: SCTL141501; PG1061252 (Other Grant/Funding Number: Australian NHMRC)