Clinical trial NCT00718250: Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Leukemia, Myeloid, Acute
Keywords: Acute myeloid leukaemia
Cancer vaccines
Immunotherapy
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Department of Health
name: Leukemia Research Fund
name: Elimination of Leukaemia Fund
First posted: 2008-07-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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 GvHD
* 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%)

Primary outcomes:
measure: Toxicity and safety of the 'AML Cell Vaccine'
timeFrame: one year
Secondary outcomes:
measure: relapse, leukaemia free survival and overall survival
timeFrame: one year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
affiliation: King's College London, London, United Kingdom
name: Ghulam J Mufti
role: PRINCIPAL_INVESTIGATOR
References: