Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2
A Phase I Study of Lentivirus Transduced Acute Myeloid Leukaemic Cells (AML) Expressing B7.1 (CD80) and IL-2 for the Potential Enhancement of Graft Versus Leukaemia(GvL) Effect in Poor Prognosis AML
  • Phase

    Phase 1
  • Study Type

  • Status

    Unknown status
  • Intervention/Treatment

    leukocytes rfusin2-aml1 ...
  • Study Participants

The purpose of this study is to assess the safety and tolerability of an 'AML Cell Vaccine' in patients with poor prognosis acute myeloid leukaemia (AML).
Study Started
May 31
Primary Completion
May 31
Study Completion
Feb 29
Last Update
Jul 18

Biological RFUSIN2-AML1

AML cell vaccine alone. x4 doses 3 weeks apart

Biological Donor leukocyte infusion (DLI)

1 dose 1x107/kg

  • Other names: RFUSIN2-AML1

Biological RFUSIN2-AML1 and donor leukocyte infusion

AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose

  • Other names: RFUSIN2-AML1

Biological RFUSIN2-AML1 and donor leukocyte infusion

AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose

  • Other names: RFUSIN2-AML1

cohort 1 Experimental

AML Cell Vaccine alone

cohort 2 Experimental

Donor leukocytes alone

cohort 3 Experimental

AML cell vaccine and Donor Leukocyte Infusion (1x107/kg)

cohort 4 Experimental

AML cell vaccine and Donor Leukocyte Infusion (1x108/kg)


Inclusion Criteria:

Diagnosis of AML defined according to the WHO classification
Age ≥ 18 years
New presentation or relapsed AML
Patients must be able to give written informed consent
Failure to enter complete morphological remission (>5% bone marrow AML cells) or persistence of cytogenetic abnormality following intensive combination chemotherapy At day+100 post-transplant
HIV negative
No continuing use of immunosuppressive drugs
Absence of active systemic fungal or viral infection including HTLV-1, hepatitis B or C.
Adequate renal and liver function confirmed by: creatinine clearance >30mls/min; bilirubin <3.0 x upper limit of normal; AST <3.0 x upper limit of normal; prothrombin time <2.0 x upper limit of normal.

Performance status of 1 or less by ECOG criteria or >80% by the Karnovsky score

Patient must provide written informed consent and be willing to comply for the duration of the study.
Life expectancy >36 weeks
Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 10 - 14 days and again within 24 hours of starting the study. In addition, sexually active WCBP must agree continued abstinence from heterosexual intercourse or to use adequate contraceptive methods starting 4 weeks prior to the initiation of therapy (see appendix G for pregnancy testing and birth control guidelines while on study). WCBP must agree to have pregnancy tests every 3 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug. Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy.

Exclusion Criteria:

Age < 18 years
Patients not fit for intensive chemotherapy
Complete morphological and cytogenetic remission following intensive combination chemotherapy
Absence of HLA compatible donor
HIV positive
Evidence of graft versus host disease at day+100 post transplant
Evidence of relapse of leukaemia (≥5% bone marrow blasts)
Concurrent use of other forms of anti-leukaemic therapy
Other malignancy with the exception of carcinoma in situ.
Significant history of heart disease (unstable angina, myocardial within the past six months, congestive cardiac failure requiring daily treatment)
Evidence of active lung disease determined by chest x-ray and absence of chronic lung disease (FEV1<60% predicted, Vital capacity <60%, Tlco<50%)
No Results Posted