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

NCT00718250 | Unknown Phase 1 DMC

• 3 other identifiers: O5CC14EudraCT 2005-000806-29GTAC GTAC098
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Leukemia, Myeloid, Acute

Keywords

Acute myeloid leukaemia; Cancer vaccines; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Toxicity and safety of the 'AML Cell Vaccine'

  one year

Secondary Outcomes (1)

• relapse, leukaemia free survival and overall survival

  one year

Study Arms (4)

cohort 1

EXPERIMENTAL

AML Cell Vaccine alone

Biological: RFUSIN2-AML1

cohort 2

EXPERIMENTAL

Donor leukocytes alone

Biological: Donor leukocyte infusion (DLI)

cohort 3

EXPERIMENTAL

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

Biological: RFUSIN2-AML1 and donor leukocyte infusion

cohort 4

EXPERIMENTAL

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

Biological: RFUSIN2-AML1 and donor leukocyte infusion

Interventions

RFUSIN2-AML1 BIOLOGICAL

AML cell vaccine alone. x4 doses 3 weeks apart

cohort 1

Donor leukocyte infusion (DLI) BIOLOGICAL

1 dose 1x107/kg

Also known as: RFUSIN2-AML1

cohort 2

RFUSIN2-AML1 and donor leukocyte infusion BIOLOGICAL

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

Also known as: RFUSIN2-AML1

cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%)

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Department of Health: collaborator
• Leukemia Research Fund: collaborator
• Elimination of Leukaemia Fund: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ghulam J Mufti

  King's College London, London, United Kingdom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghulam J Mufti

CONTACT

+44 2032999000; ghulam.mufti@kcl.ac.uk

Wendy Ingram

CONTACT

+44 2032999000; wendy.ingram@kch.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: July 18, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: February 1, 2012
• Last Updated: July 18, 2008

Record last verified: 2008-07

Locations

GB (1)