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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • Toxicity and safety of the 'AML Cell Vaccine' [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • relapse, leukaemia free survival and overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cohort 1
AML Cell Vaccine alone
Biological: RFUSIN2-AML1
AML cell vaccine alone. x4 doses 3 weeks apart
Other Name: RFUSIN2-AML1
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718250

Contacts
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

Locations
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
Investigators
Principal Investigator: Ghulam J Mufti King's College London, London, United Kingdom
  More Information

No publications provided

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, GTAC GTAC098
Study First Received: June 6, 2008
Last Updated: July 16, 2008
Health Authority: United Kingdom: Gene Therapy Advisory Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014