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

July 16, 2008 updated by: King's College Hospital NHS Trust

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • RFUSIN2-AML1
EXPERIMENTAL: cohort 4
AML cell vaccine and Donor Leukocyte Infusion (1x108/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 Names:
  • 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 Names:
  • RFUSIN2-AML1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity and safety of the 'AML Cell Vaccine'
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
relapse, leukaemia free survival and overall survival
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Collaborators

Leukemia Research Fund
Department of Health
Elimination of Leukaemia Fund

Investigators

  • Principal Investigator: Ghulam J Mufti, King's College London, London, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ANTICIPATED)

May 1, 2011

Study Completion (ANTICIPATED)

February 1, 2012

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria

July 16, 2008

First Posted (ESTIMATE)

July 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 18, 2008

Last Update Submitted That Met QC Criteria

July 16, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O5CC14
  • EudraCT 2005-000806-29
  • GTAC GTAC098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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