MiniAlloGlivec

MiniAlloGlivec: A phase I/II study of the use of glivec in patients undergoing reduced intensity allografting for chronic myeloid leukaemia
 
 Chief Investigator:
  Prof Charles Craddock
 Sponsor:  University Hospital Birmingham NHS Foundation Trust
 Funder:  Novartis
Disease Site:   Haematology Malignancies
 Trial Type:   Clinical Trial of an Investigational Medicinal Product
 Status:  Complete
 UKCRN Study ID (if applicable):  N/A
 ISRCTN Referance Number:  N/A
 Open to New Sites?  No
 Recruitment Start Date: 16-Jul-2002
 Recruitment End Date: 05-Feb-2008
 CRCTU Trial Management Team: Haem Team
 Trial Email Address: can-crctu-haematology@adf.bham.ac.uk

Trial Summary

Mini Allo Glivec is a phase I/II, single arm, multicentre study of a targeted drug called ‘Imatinib’ in patients undergoing reduced intensity allogeneic stem cell transplantation (or a ‘mini transplant’ for chronic myeloid leukaemia (CML) in 1st chronic phase. The main objectives of the trial were to assess the safety and tolerability of receiving Imatinib after undergoing a ‘mini transplant’ and to investigate the ‘anti-leukaemic activity’ of a ‘mini transplant’ when given with adjunctive targeted therapy in the form of Imatinib.

The trial looked at the results of 21 of the 22 people recruited to this trial and the study showed that giving targeted therapy after a ‘mini’ transplant increased the amount of time before CML came back. It also showed that there was a low risk of side effects with this combination of treatment.

After undergoing a ‘mini transplant’ all patients took Imatinib therapy for 1 year. Tests after finishing Imatinib showed that 7 patients had no sign of CML. The most common side effect of imatinib was feeling or being sick.

Of the 21 people, 15 had CML come back after their transplant. The average amount of time it took to come back was 17 months. After more treatment 10 of the 15 had no sign of CML.

After the transplant only 1 person had Graft Versus Host Disease (GVHD) as a complication. After further treatment when CML came back, 2 people had GVHD.

Out of the 21 people 19 were alive at least 3 years after treatment.

The researchers concluded that this combination of treatment worked well for people having a mini transplant. And there was a low risk of side effects or complications.

Please note that the trials team cannot give individual’s clinical advice.

Summary of the Trials Results

A lay summary of the trial results can be found on the Cancer Research UK website see Other Websites for the link.

A list of published papers and abstracts is below:

Papers

Olavarria E, Siddique S, et al. . Posttransplantation imatinib as a strategy to postpone the requirement for immunotherapy in patients undergoing reduced-intensity allografts for chronic myeloid leukemia. (2007) Blood 110(13): 4614-7.

Abstracts

Craddock C, Olavarria E, Griffiths M, Arrazi JM, Siddique S, Lennard A, Byrne J.  Combined tyrosine kinase inhibition and immunotherapy as a strategy to improve outcome after reduced intensity allogeneic stem cell transplantation in chronic myeloid leukaemia (CML). Abstr. 0437, EHA 2006, Amsterdam. 

Craddock CF, Griffiths MJ, Arrazi JM, Siddique S, Pallan L, Lennard AL, Byrne JL, Olavarria E. The Use of Adjunctive Leukemia Specific Therapy To Improve Outcome in Patients with Chronic Myeloid Leukemia Transplanted Using a Reduced Intensity Conditioning (RIC) Regimen. Poster 357, CIBMTR 2007. 

Other Websites

CancerHelp (Cancer Research)