Condition category
Cancer
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
21/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctsu.ox.ac.uk/projects/leuk/ukallxii/new-4th-dec-2006/ukallxii-protocol-version-5-0.pdf

Contact information

Type

Scientific

Primary contact

Professor A Goldstone

ORCID ID

Contact details

University College Hospital
Gower Street
London
WC1E 6AU
United Kingdom

Additional identifiers

EudraCT number

2005-006181-31

ClinicalTrials.gov number

NCT00002514

Protocol/serial number

G8223452, MREC/02/2/84

Study information

Scientific title

Acronym

UKALLXII

Study hypothesis

1. To compare effects of marrow ablative therapy using VP16 and total body irradiation followed by autologous bone marrow rescue (ABMT or Peripheral Stem Cell Rescue) with conventional consolidation and maintenance chemotherapy in adult patients between 15 and 55 years who have no HLA compatible donor
2. To examine (in a non-randomised study) differences in outcome in adult ALL in those patients who have an HLA compatible donor, who will be allocated allogeneic BMT versus those with a donor randomised to autologous BMT or conventional chemotherapy
3. To compare the outcome of the above three treatments or matched unrelated donor BMT in patients with Philadelphia chromosome positive disease and to examine the efficacy of additional Interferon during maintenance chemotherapy or after BMT

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Leukaemia

Intervention

1. Marrow ablative therapy using VP16 and total body irradiation followed by autologous bone marrow rescue (ABMT or Peripheral Stem Cell Rescue)
2. Conventional consolidation and maintenance chemotherapy

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Length of survival
2. Relapse rates

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/1993

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients between 15 and 55 years with previously untreated ALL
2. Morphological proof of ALL
3. Diagnosis has been made from bone marrow morphology with greater than 25% lymphoblasts by the French-American-British (FAB) criteria

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

550

Participant exclusion criteria

1. Prior malignancy for which chemotherapy or radiotherapy have been given
2. AML, MDS or other antecedent haematological disorder or lymphoid transformation of chronic myeloid leukaemia
3. Previously treated
4. Intercurrent life threatening disease
5. Pregnant or lactating

Recruitment start date

01/01/1993

Recruitment end date

30/09/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College Hospital
London
WC1E 6AU
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16556888
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/16421910
3. 2009 results on prospective outcome data in http://www.ncbi.nlm.nih.gov/pubmed/19244158
4. 2009 results on clinical and biological features of participants in http://www.ncbi.nlm.nih.gov/pubmed/19828704

Publication citations

  1. Results

    Lazarus HM, Richards SM, Chopra R, Litzow MR, Burnett AK, Wiernik PH, Franklin IM, Tallman MS, Cook L, Buck G, Durrant IJ, Rowe JM, Goldstone AH, , Central nervous system involvement in adult acute lymphoblastic leukemia at diagnosis: results from the international ALL trial MRC UKALL XII/ECOG E2993., Blood, 2006, 108, 2, 465-472, doi: 10.1182/blood-2005-11-4666.

  2. Results

    Ramanujachar R, Richards S, Hann I, Goldstone A, Mitchell C, Vora A, Rowe J, Webb D, Adolescents with acute lymphoblastic leukaemia: outcome on UK national paediatric (ALL97) and adult (UKALLXII/E2993) trials., Pediatr Blood Cancer, 2007, 48, 3, 254-261, doi: 10.1002/pbc.20749.

  3. Results on prospective outcome data

    Fielding AK, Rowe JM, Richards SM, Buck G, Moorman AV, Durrant IJ, Marks DI, McMillan AK, Litzow MR, Lazarus HM, Foroni L, Dewald G, Franklin IM, Luger SM, Paietta E, Wiernik PH, Tallman MS, Goldstone AH, Prospective outcome data on 267 unselected adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia confirms superiority of allogeneic transplantation over chemotherapy in the pre-imatinib era: results from the International ALL Trial MRC UKALLXII/ECOG2993., Blood, 2009, 113, 19, 4489-4496, doi: 10.1182/blood-2009-01-199380.

  4. Results on clinical and biological features of participants

    Marks DI, Paietta EM, Moorman AV, Richards SM, Buck G, DeWald G, Ferrando A, Fielding AK, Goldstone AH, Ketterling RP, Litzow MR, Luger SM, McMillan AK, Mansour MR, Rowe JM, Tallman MS, Lazarus HM, T-cell acute lymphoblastic leukemia in adults: clinical features, immunophenotype, cytogenetics, and outcome from the large randomized prospective trial (UKALL XII/ECOG 2993)., Blood, 2009, 114, 25, 5136-5145, doi: 10.1182/blood-2009-08-231217.

Additional files

Editorial Notes