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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Myeloid, Acute

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Trial Information

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


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%)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity and safety of the 'AML Cell Vaccine'

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

Ghulam J Mufti

Investigator Role:

Principal Investigator

Investigator Affiliation:

King's College London, London, United Kingdom

Authority:

United Kingdom: Gene Therapy Advisory Committee

Study ID:

O5CC14

NCT ID:

NCT00718250

Start Date:

May 2008

Completion Date:

February 2012

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Acute myeloid leukaemia
  • Cancer vaccines
  • Immunotherapy
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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