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Leukaemia Research Fund
*information and education
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*Diseases
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*Chronic Myeloid Leukaemia Trials
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*Information Booklet

A booklet produced by Leukaemia Research Fund giving background information on clinical trials is available to download.
resourceClinical Trials - PDF

Text version of the booklet

*Registers of Trials

Current Controlled Trials
International Cancer Research Portfolio - a register of UK and US cancer research (including trials)

Last updated 14/11/2008

*Leukaemia Research sponsored trials

WT1 peptide vaccination for leukaemia - a phase I/II pilot study
Type:Phase I/II
Status:Not Stated
The aim of this trial is to use a vaccine that stimulates an immune response against malignant blood cells that display the Wilms tumour antigen-1 (WT1). High levels of WT1 are usually produced by leukaemia cells in patients with acute or chronic myeloid leukaemia and patients with myelodysplastic syndrome (MDS). Although treatments for this group of patients are available, WT1 vaccination may offer a better alternative to the currently available treatments.

A Phase I/II feasibility study of peptide vaccination in chronic myeloid leukaemia; Acronym: EPIC
Type:Phase I/II
Status:Not Stated
The leukaemia cells in patients with chronic myeloid leukaemia have a protein marker on their surface that is made of parts of the BCR-ABL onco-protein. These markers can be recognised by the immune system, which in turn can mount a reaction and destroy these malignant cells. Unfortunately, the immune reaction can be very weak and sometimes does not occur at all. The aim of this study is to use BCR-ABL peptides, produced in the laboratory and vaccinate patients with them in order to enhance the immune response and hopefully destroy the leukaemia cells.

GIMI - A pilot study of continuous imatinib mesylate (IM) versus pulsed IM with or without Lenogastrim (rHU-GCSF) in CML patients who have achieved a complete cytogenetic remission
Trial Code:56578157
Type:Pilot study
Status:Open
Link:http://www.controlled-trials.com/mrct/trial/GIMI/1...
Imatinib mesylate (IM) or Glivec is a drug that is successfully used to keep chronic myeloid leukaemia (CML) under control, but so far does not cure the disease. Laboratory studies revealed an increased number of “quiet” leukaemia cells, i. e. cells that do not divide and participate in the cell cycle, following treatment with Glivec. In order to activate these “quiet” cells and thus enable their complete destruction, Glivec will not be given to patients continuously as usual, but pulsed. This means that there will be a time where the patient does not take any medication. To see if treatment outcome can further be improved, the Growth factor Lenogastrim will be added to the pulsed Glivec regime in another patient group.

Last updated 14/11/2008

*Non-Leukaemia Research sponsored trials

The clinical effectiveness and cost-effectiveness of imatinib in the treatment of chronic myeloid leukaemia
Type:Phase III
Status:Complete
Link:http://www.controlled-trials.com/mrct/trial/CHRONI...
Main research question: What is the effectiveness and cost effectiveness of Imatinib (STI 571) in the treatment of chronic myeloid leukaemia?

CML V - chronic phase chronic myeloid leukaemia
Trial Code:68784584
Type:Phase III
Status:Open
Link:http://www.controlled-trials.com/isrctn/trial/|/0/...
High/low-dose IFN.
Optional use of arm-C in addition to randomised IFN therapy.

CML IV - An MRC prospective randomised study to compare interferon a n1 (wellferon) against 'IDAC' chemotherapy and autografting followed by interferon a n1 in patients with newly diagnosed chronic phase myeloid leukaemia.
Trial Code:61147621
Type:Phase III
Status:Complete
Link:http://www.controlled-trials.com/mrct/trial/CHRONI...
The aim of the trial is to attempt to improve on the best current therapy in chronic phase CML for those patients who do not undergo allogeneic bone marrow transplantation. The two arms of the trial will therefore compare interferon alpha (IFN) maintenance therapy alone against a cycle of high dose chemotherapy followed by an autograft and then IFN maintenance therapy

Mini-Allografting to complement treatment with Glivec (Imatinib - formerly known as STI571) to eradicate minimal residual disease (MRD) in Chronic Myeloid Leukaemia (CML) patients aged 65 years and under with matched sibling donors.
Trial Code:86187144
Type:Not stated
Status:Ongoing
Link:http://www.controlled-trials.com/mrct/trial/861871...
To develop a novel clinical immune-therapeutic strategy for CML patients aged 65 and under, found to have suitable matched sibling allogeneic donors, and following remission induction with Glivec.

Last updated 14/11/2008
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