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Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2 (RFUSIN2-AML1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00718250
Recruitment Status : Unknown
Verified July 2008 by King's College Hospital NHS Trust.
Recruitment status was:  Recruiting
First Posted : July 18, 2008
Last Update Posted : July 18, 2008
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Biological: RFUSIN2-AML1 Biological: Donor leukocyte infusion (DLI) Biological: RFUSIN2-AML1 and donor leukocyte infusion Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2008
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : February 2012

Arms and Interventions

Arm Intervention/treatment
Experimental: cohort 1
AML Cell Vaccine alone
Biological: RFUSIN2-AML1
AML cell vaccine alone. x4 doses 3 weeks apart
Experimental: cohort 2
Donor leukocytes alone
Biological: Donor leukocyte infusion (DLI)
1 dose 1x107/kg
Other Name: RFUSIN2-AML1
Experimental: cohort 3
AML cell vaccine and Donor Leukocyte Infusion (1x107/kg)
Biological: RFUSIN2-AML1 and donor leukocyte infusion
AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose
Other Name: RFUSIN2-AML1
Experimental: cohort 4
AML cell vaccine and Donor Leukocyte Infusion (1x108/kg)
Biological: RFUSIN2-AML1 and donor leukocyte infusion
AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose
Other Name: RFUSIN2-AML1

Outcome Measures

Primary Outcome Measures :
  1. Toxicity and safety of the 'AML Cell Vaccine' [ Time Frame: one year ]

Secondary Outcome Measures :
  1. relapse, leukaemia free survival and overall survival [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718250

Contact: Ghulam J Mufti +44 2032999000 ext 3080 ghulam.mufti@kcl.ac.uk
Contact: Wendy Ingram +44 2032999000 ext 4642 wendy.ingram@kch.nhs.uk

United Kingdom
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
Department of Health
Leukemia Research Fund
Elimination of Leukaemia Fund
Principal Investigator: Ghulam J Mufti King's College London, London, United Kingdom
More Information

Responsible Party: Dr Lorraine Catt, Research and Development Manager, King's College Hospital NHS Foundation Trust, London, United Kingdom
ClinicalTrials.gov Identifier: NCT00718250     History of Changes
Other Study ID Numbers: O5CC14
EudraCT 2005-000806-29
First Posted: July 18, 2008    Key Record Dates
Last Update Posted: July 18, 2008
Last Verified: July 2008

Keywords provided by King's College Hospital NHS Trust:
Acute myeloid leukaemia
Cancer vaccines

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs