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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by King's College Hospital NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Department of Health
Leukemia Research Fund
Elimination of Leukaemia Fund
Information provided by:
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT00718250
First received: June 6, 2008
Last updated: July 16, 2008
Last verified: July 2008

June 6, 2008
July 16, 2008
May 2008
May 2011   (final data collection date for primary outcome measure)
Toxicity and safety of the 'AML Cell Vaccine' [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00718250 on ClinicalTrials.gov Archive Site
relapse, leukaemia free survival and overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2
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

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).

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Myeloid, Acute
  • Biological: RFUSIN2-AML1
    AML cell vaccine alone. x4 doses 3 weeks apart
    Other Name: RFUSIN2-AML1
  • Biological: Donor leukocyte infusion (DLI)
    1 dose 1x107/kg
    Other Name: RFUSIN2-AML1
  • 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
  • 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
  • Experimental: cohort 1
    AML Cell Vaccine alone
    Intervention: Biological: RFUSIN2-AML1
  • Experimental: cohort 2
    Donor leukocytes alone
    Intervention: Biological: Donor leukocyte infusion (DLI)
  • Experimental: cohort 3
    AML cell vaccine and Donor Leukocyte Infusion (1x107/kg)
    Intervention: Biological: RFUSIN2-AML1 and donor leukocyte infusion
  • Experimental: cohort 4
    AML cell vaccine and Donor Leukocyte Infusion (1x108/kg)
    Intervention: Biological: RFUSIN2-AML1 and donor leukocyte infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
February 2012
May 2011   (final data collection date for primary outcome measure)

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%)
Both
18 Years and older
No
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
 
NCT00718250
O5CC14, EudraCT 2005-000806-29, GTAC GTAC098
Yes
Dr Lorraine Catt, Research and Development Manager, King's College Hospital NHS Foundation Trust, London, United Kingdom
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
King's College Hospital NHS Trust
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP