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Research
Mags Bowerbank
Cancer Research Nurse
Janice Carpenter
Clinical Research Officer
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Haematology - Trials
For more information regarding trials please use the following links:
www.cancerbacup.org.uk/Trials/Understandingtrials
www.cancerbacup.org.uk/Trials/Search
ALL 2003
Paediatric Acute Lymphoblastic Leukaemia - protocol for all childhood ALL in the UK. Treatment based on clinical risk with randomised changes to treatment on the basis of Minimal Residual Disease status during the first few months of therapy. Children with ALL are referred to Oxford for initial treatment, with subsequent shared care and follow-up here.
AML 14
A randomised trial for people with acute myeloid leukaemia or high risk myelodysplastic syndrome aged 60 or over. There has sometimes been uncertainty as to whether intensive chemotherapy will be either tolerated or beneficial in older people with AML and this has led to them missing out on clinical trials. The AML14 Trial will evaluate two treatment strategies, an Intensive and a Non-Intensive approach. Where there is uncertainty, people with AML will be randomised between the Intensive and the Non-Intensive treatment approaches to compare outcomes. Quality of Life measurement will be a central part of this trial in assessing the relative benefits of Intensive and Non-Intensive treatment.
AML 15
Comparison of treatments in acute myeloid leukaemia (AML) in people under 60 years . For the subtype of AML known as APL, comparison is between two well tried and successful treatments, one called the “MRC approach” and the other the “Spanish approach”. Both have given very good results but this comparison is intended to help find out which is better.
For those with other sub-types of AML there is first a comparison of 3 chemotherapy drug combinations which have been used in hundreds of patients before and are known to be effective, but they have never been compared against each other. Also a new drug has become available for treating AML. This is called MylotargTM or GO (for Gemtuzumab Ozogamicin). This is the first chemotherapy that is directed specifically to the leukaemia cells and it is hoped to find out if this will improve treatment against AML. After remission is achieved there is another comparison between drugs to prevent relapse, or it may be possible to have a stem cell transplant.
Part of the trial involves looking at the molecular differences in the leukaemic cells and participants will be asked to allow some blood will be stored for future research.
BNLI Radiation Dose
This trial aims to establish the best dose of radiotherapy to give in Non Hodgkins Lymphoma. Trial closed but still following patients up.
CLL4
A Leukaemia Research Fund sponsored trial comparing conventional therapy (chlorambucil ) with fludarabine used alone or in combination with cyclophosphamide in Chronic Lymphocytic Leukaemia. For patients needing further treatment there is a second randomisation to look at the use of a laboratory test of drug sensitivity to decide the choice of your next treatment. The test is designed to identify which drugs will be effective and which may not be effective against leukaemia in a particular person. But it can delay treatment for 7 – 10 days so randomisation will be used to decide whether or not it is tried.
Blood will also be taken to compare 4 genetic markers to see if any of them help predict outcomes in CLL. The target was originally to enrol 500 patients but the study has been extended until January 2006 to recruit 750 patients.
CLL5
For people with High Risk Chronic Lymphocytic Leukaemia (CLL) who are in complete or partial remission following first or second line treatment, there is usually a period of “wait and see” with no further treatment until they relapse again. For some people the next treatment will be Stem Cell Transplant. This trial will try to discover if giving these people transplanted stem cells early in their remission rather than waiting until the CLL has progressed will improve the outlook. The patient’s own stem cells are collected (rather than from a donor) and they are then given high doses of chemotherapy and radiotherapy to destroy the remaining traces of leukaemia in the body. This also damages the body’s healthy cells, but the collected cells are transplanted back into bone marrow to help it recover
EBMT LYM1
This trial is for patients with relapsed low-grade follicular Non-Hodgkins Lymphoma who have responded well to chemotherapy, and who are going to have high dose therapy followed by autologous (own cell) stem cell transplant. It will try to discover whether giving patients the antibody Rituximab to try to clear the blood and bone marrow of lymphoma cells, before harvesting the stem cells, will make any difference to outcomes by delaying or even preventing recurrence of the lymphoma, and also whether it is helpful to give Rituximab to patients after the high dose therapy is finished. Recruitment is slow but has reached the halfway stage nationally.
EORTC 20981
This trial is for patients with relapsed follicular Non-Hodgkins Lymphoma and attempts to discover if the adding Rituximab to CHOP chemotherapy increases its effectiveness in inducing a response and if continuing to have rituximab alone 3 monthly for up to 2 years after response has any benefit in terms of delaying or preventing recurrence afterwards.
(Recruitment briefly suspended awaiting protocol amendment.)
FMD vs CMD
For persons with follicular low grade Non-Hodgkins Lymphoma.
Comparison of two combinations of treatment Fludarabine or Chlorambusil plus Mitoxantrone and Dexamethasone (FMD vs CMD). Bone Marrow samples will be looked at regularly for evidence of persistent disease in patients with Bone Marrow involvement at the beginning. This trial has recruited half the required numbers so far.
MALT (IELSG 19)
Mucosa-associated lymphoid tissue Non-Hodgkins Lymphoma(NHL) are a group of low-grade B-cell lymphomas which behave in a similar way to each other. They account for around 8% of all NHL. Local treatment –Radiotherapy or surgery –is beneficial if there is only one site but 25%+ will have multiple sites affected. Chlorambucil is the main agent used in chemotherapy. This trial looks at whether adding the new agent, Rituximab, which has been effective against other follicular lymphomas, would improve the outcome compared with giving Chlorambucil alone. 17 out of 80 recruited so far.
Mantle Cell Lymphoma (ALLG LY05)
Mantle Cell Lymphoma comprises 5% of Non-Hodgkins Lymphoma (NHL). This is a Phase II trial to assess the effects of Fludarabine plus Cyclophosphamide in these patients and to discover whether adding Rituximab improves the outcome. The trial will look at response rates, time to progression and toxicity. It has reached its recruitment target but an extension has been approved so is continuing to recruit meantime.
Myeloma IX
A Trial mostly for those newly diagnosed with Multiple Myeloma. There are 2 treatment pathways depending on the age and general fitness of the person involved.
The younger, fitter group are split to allow a comparison between having two different induction chemotherapy regimens and between 2 sorts of a class of drug known as Bisphosphonates (these drugs have been shown to reduce the rates of fracture and of hypercalcaemia which those with MM are prone to have) . Those with suitably matched brothers or sisters will also be given an allogeneic transplant. They will then be randomised between having continued maintainance treatment (with Thalidomide) or having no maintainance therapy.
Those who are considered suitable for the less intensive treatment are also split between 2 induction chemo therapy regimes and 2 sorts of bisphosphonates, and are randomised between having continued maintainance treatment (with Thalidomide) or having no maintainance. The trial will also look at quality of life on the different treatments.
MERIT
A Trial for those newly diagnosed with Multiple Myeloma who are in Acute Renal Failure. The trial compares outcomes between those treated with chemotherapy only and those who have Plasma exchange in addition to chemotherapy. (Those having Plasma Exchange are sent to the Renal Unit in Oxford.)
LY10
Burkitt’s and Burkitt-like NHL. Burkitts is a rare form of B-cell Non-Hodgkins Lymphoma most common in children and young adults. It presents either as a rapidly growing tumour mass or with bore marrow involvement and leukaemia. Treatment is usually a brief intense course of chemotherapy. The Pathology study will look at tissue from the tumour with a view to describing the cell morphology, and genetics and seeing whether there is any association between these and various patient characteristics such as age or disease characteristics such as response to treatment. There is also a phase II clinical study looking at the activity of drug combination CODOX-M in low risk patients, and alternating cycles of CODOX-M and IVAC in high risk patients. Participants may choose whether they wish to take part in both aspects of the study, or only the pathology part.
PT 1 (Primary Thrombo cythaemia 1)
Originally a three-part study, only the low and intermediate risk arms now open. Low risk patients with Primary Thrombocythaemia aged under 40 with platelet levels between 600 and 1500 x 109 /L will have aspirin alone in an observational study. Intermendiate risk patients aged between 40 and 59 years with platelet levels between 600 and 1500 x 109 /L will be randomised between aspirin alone and aspirin and hydroxyurea. The objective is to look at incidence of blood clots and whether taking these medications adversely affects ones’ quality of life.
UKALL XII
A study for people with Acute Lymphoblastic Leukaemia (ALL). All patients have 8 weeks of chemotherapy to induce remission. They are tested to see if their leukaemia is of the Philadelphia +ve or –ve type as this will determine the later treatment. Siblings are tested to see if there are any compatible donors.
Ph-ve patients will have chemotherapy for 4 weeks and then those with suitable donors will have BM transplant. Those without will be randomised between bone marrow/stem cell transplant using the patients own cells and a course of Radio - and chemo-therapy. Ph+ve patients are given a new drug called imatinib which targets a protein in Ph+ patients which makes these leukaemia cells grow aggressively. They will then have a BM transplant, either donor sibling or own cells and have maintainance imatinib afterwards.
Waldenstrom’s Macro-Globulinaemia (WM1)
(lymphoplasmocytic lymphoma)
Chronic B-cell lymphoproliferation with infiltration of Bone Marrow by small lymphocytes and plasma cell types producing an excess of IgM. Treatment has conventionally been with Chlorambucil either asl ow dose or as a pulsed regimen, and this trial will compare Chlorambucil with Fludarabine which has already been shown to be effective as second line therapy in WM.
WARP
This study looks at whether giving warfarin to patients having chemotherapy through central lines is effective in preventing clotting, either in the line or in the vein. We already routinely give low dose warfarin to all patients having some types of central lines and are only inviting patients having a type called “PICC” lines to take part in this study. Trial closed but still following patients up.
CAMFLUD (UKCLL 02)
CLL is the commonest adult leukaemia, and its incidence increases with age. This trial concerns patients who have had treatment for CLL and either failed to respond or have relapsed within 6 months of treatment. It looks at the effects of a new antibody-based treatment, Mab-Campath, and also the effect of combination treatment, with Fludarabine added if there is progression of disease at 6 weeks or no response by 12 weeks after the start of MabCampath. There is some evidence that the combination may be much better than either alone. It will also investigate blood and bone marrow tests to see if it is possible to predict the response to treatment.
CML and MDS
A local study looking at disease progression and possible genetic changes in the leukaemic cells which might be used to predict these changes in future. The study involves taking blood tests and bone marrow throughout the course of the disease.
ALK +ve Lymphoma
Recent research in Oxford has discovered a protein in some patients who have Lymphoma which may be an indicator of prognosis. The study involves taking blood tests throughout the course of the disease to see how levels of the protein vary.
RCHOP 14 vs RCHOP 21
Open to recruitment. ( A phase III multicentre, randomised clinical trial comparing rituximab with CHOP given every 14 days vs rituximab with CHOP given every 21 days for the treatment of patients with newly diagnosed diffuse large B cell NHL).
SPIRIT
Will soon be open to patient recruitment. ( ST1571 - imatinib Prospective International Randomised Trial). A phase III prospective, randomised comparison of imatinib 400mg daily vs imatinib 800 mg daily vs imatinib 400mg plus PEG interferon in patients with newly diagnosed chronic phase CML.
PET
A randomised phase III trial to determine the role of FDG PET Imaging in Clinical Stages 1A/11A Hodgkins Disease.
This trial is sponsored by the Leukaemia Research Fund. Patients receive three cycles of ABVD chemotherapy followed by FDG PET imaging. PET +ve patients will receive a 4th cycle of ABVD and involved field radiotherapy. PET -ve patients will be randomised to receive either involved field radiotherapy or no further treatment.
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