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

Leukemia, Myeloid, Acute Clinical Trial

— RFUSIN2-AML1  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00718250
• Other study ID #: O5CC14
• Secondary ID: EudraCT 2005-000
• Status: Recruiting
• Phase: Phase 1
• First received: June 6, 2008
• Last updated: July 16, 2008
• Start date: May 2008
• Est. completion date: February 2012

Study information

• Verified date: July 2008
• Source: King's College Hospital NHS Trust
• Contact: Ghulam J Mufti
• Phone: +44 2032999000
• Email: ghulam.mufti[@]kcl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Gene Therapy Advisory CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: February 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Biological:
• RFUSIN2-AML1
AML cell vaccine alone. x4 doses 3 weeks apart
• Donor leukocyte infusion (DLI)
1 dose 1x107/kg
• RFUSIN2-AML1 and donor leukocyte infusion
AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose
• RFUSIN2-AML1 and donor leukocyte infusion
AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (4)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	Department of Health, Elimination of Leukaemia Fund, Leukemia Research Fund

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity and safety of the 'AML Cell Vaccine'		one year	Yes
Secondary	relapse, leukaemia free survival and overall survival		one year	No