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

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ClinicalTrials.gov Identifier: NCT02189824
Recruitment Status : Unknown
Verified October 2015 by University of Sydney.
Recruitment status was:  Recruiting
First Posted : July 15, 2014
Last Update Posted : November 1, 2015
Sponsor:
Collaborators:
Melbourne Health
Royal Brisbane and Women's Hospital
Information provided by (Responsible Party):
University of Sydney

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukaemia Biological: Partially HLA-matched unrelated donor cells Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
Study Start Date : August 2014
Estimated Primary Completion Date : December 2016


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



Primary Outcome Measures :
  1. Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Duration of post chemotherapy cytopenias [ Time Frame: 60 days ]
  2. Remission rate [ Time Frame: 12 months ]
  3. Duration of complete remission [ Time Frame: 12 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189824


Contacts
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Contact: Emily Blyth emily.blyth@sydney.edu.au

Locations
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Australia, New South Wales
Westmead Hospital Department of Haematology Recruiting
Westmead, Sydney, New South Wales, Australia, 2145
Contact: Emily Blyth    +61 2 9845 6274    emily.blyth@sydney.edu.au   
Principal Investigator: David Gottlieb         
Sub-Investigator: Emily Blyth         
Sponsors and Collaborators
University of Sydney
Melbourne Health
Royal Brisbane and Women's Hospital
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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT02189824    
Other Study ID Numbers: SCTL141501
PG1061252 ( Other Grant/Funding Number: Australian NHMRC )
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: November 1, 2015
Last Verified: October 2015