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

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

NCT ID: NCT00718250

Condition: Leukemia, Myeloid, Acute

Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Conditions: Keywords:
Acute myeloid leukaemia
Cancer vaccines
Immunotherapy

Study type: Interventional

Study phase: Phase 1

Overall status: Unknown status

Study design:

Allocation: Non-Randomized

Intervention model: Factorial Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: RFUSIN2-AML1
Description: AML cell vaccine alone. x4 doses 3 weeks apart
Arm group label: cohort 1

Intervention type: Biological
Intervention name: Donor leukocyte infusion (DLI)
Description: 1 dose 1x107/kg
Arm group label: cohort 2

Other name: RFUSIN2-AML1

Intervention type: Biological
Intervention name: RFUSIN2-AML1 and donor leukocyte infusion
Description: AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose
Arm group label: cohort 3

Other name: RFUSIN2-AML1

Intervention type: Biological
Intervention name: RFUSIN2-AML1 and donor leukocyte infusion
Description: AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose
Arm group label: cohort 4

Other name: RFUSIN2-AML1

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).

Criteria for 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%)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: King's College Hospital NHS Foundation Trust

Address:
City: London
Zip: SE5 9RS
Country: United Kingdom

Status: Recruiting

Start date: May 2008

Completion date: February 2012

Lead sponsor:
Agency: King's College Hospital NHS Trust
Agency class: Other

Collaborator:
Agency: Department of Health
Agency class: Other

Collaborator:
Agency: Leukemia Research Fund
Agency class: Other

Collaborator:
Agency: Elimination of Leukaemia Fund
Agency class: Other

Source: King's College Hospital NHS Trust

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00718250