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

University of Sydney

Status and phase: Unknown; Phase 1

Conditions: Acute Myeloid Leukaemia

Treatments: Biological: Partially HLA-matched unrelated donor cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02189824

PG1061252 (Other Grant/Funding Number)

SCTL141501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Infusion of partially matched unrelated donor cells

Experimental group

Treatment:

Biological: Partially HLA-matched unrelated donor cells