Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2

Phase 1

• Conditions: Leukemia, Myeloid, Acute

• Registration Number: NCT00718250
• Lead Sponsor: King's College Hospital NHS Trust

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-06
• Status Verified: 2008-07
• Study First Submitted QC: 2008-07-16
• Last Update Submitted: 2008-07-16
• Study First Posted: 2008-07-18
• Last Update Posted: 2008-07-18
• Primary Completion: 2011-05
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Toxicity and safety of the 'AML Cell Vaccine'	one year

Secondary Outcome Measures

Name	Time	Method
relapse, leukaemia free survival and overall survival	one year

Trial Locations

Locations (1)

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom