Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2
NCT ID: NCT00718250
Last Updated: 2008-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2008-05-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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cohort 1
AML Cell Vaccine alone
RFUSIN2-AML1
AML cell vaccine alone. x4 doses 3 weeks apart
cohort 2
Donor leukocytes alone
Donor leukocyte infusion (DLI)
1 dose 1x107/kg
cohort 3
AML cell vaccine and Donor Leukocyte Infusion (1x107/kg)
RFUSIN2-AML1 and donor leukocyte infusion
AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose
cohort 4
AML cell vaccine and Donor Leukocyte Infusion (1x108/kg)
RFUSIN2-AML1 and donor leukocyte infusion
AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose
Interventions
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RFUSIN2-AML1
AML cell vaccine alone. x4 doses 3 weeks apart
Donor leukocyte infusion (DLI)
1 dose 1x107/kg
RFUSIN2-AML1 and donor leukocyte infusion
AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose
RFUSIN2-AML1 and donor leukocyte infusion
AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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%)
18 Years
ALL
No
Sponsors
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Department of Health
AMBIG
Leukemia Research Fund
OTHER
Elimination of Leukaemia Fund
OTHER
King's College Hospital NHS Trust
OTHER
Responsible Party
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King's College Hospital NHS Foundation Trust, London, United Kingdom
Principal Investigators
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Ghulam J Mufti
Role: PRINCIPAL_INVESTIGATOR
King's College London, London, United Kingdom
Locations
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King's College Hospital NHS Foundation Trust
London, London, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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EudraCT 2005-000806-29
Identifier Type: -
Identifier Source: secondary_id
GTAC GTAC098
Identifier Type: -
Identifier Source: secondary_id
O5CC14
Identifier Type: -
Identifier Source: org_study_id