A Study for Older Adults With Acute Lymphoblastic Leukaemia (UKALL60+)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University College, London.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Cancer Research UK
Stichting Hemato-Oncologie voor Volwassenen Nederland
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01616238
First received: June 7, 2012
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to carry out a prospective, non randomised multi-arm study (including a choice of regimen intensity) to investigate the safety, tolerability and feasibility of a standardised therapy protocol for patients ≥ 60 years old with de novo ALL. The overall aim is define a basic standard of care upon which trials of novel therapies will be based in future. The design of the study will enable collection of a comprehensive dataset regarding the clinical outcome, Complete Response Rate (CR) and Minimal Residual Disease (MRD) response rates in a previously completely uncharacterised population, thus providing the essential platform for designing future randomised advanced phase studies in which new therapeutic approaches and novel therapies can be prospectively investigated.


Condition
Acute Lymphoblastic Leukaemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Complete remission rate after 2 phases of induction [ Time Frame: Approximately 2 months after start of treatment ] [ Designated as safety issue: No ]
    All patients will be assessed for their remission status at the end of Phase 2 induction. The CR rate at this timepoint will then be calculated.


Secondary Outcome Measures:
  • Complete remission rate after 1 phase of induction [ Time Frame: Approximately 1 month after start of treatment ] [ Designated as safety issue: No ]
    All patients will be assessed for their remission status at the end of Phase 1 induction. The CR rate at this timepoint will then be calculated.

  • Overall Survival at 1 year [ Time Frame: 1 year after registration ] [ Designated as safety issue: No ]
    Overall survival for all patients will be measured 1 year after registration

  • Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence. [ Time Frame: At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment ] [ Designated as safety issue: No ]
    MRD levels will be measured at distinct timepoints during the trial.


Biospecimen Retention:   Samples Without DNA

Bone marrow aspirate and peripheral blood samples


Estimated Enrollment: 148
Study Start Date: September 2012
Groups/Cohorts
Philadelphia Positive Patients
All patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen
Philadelphia -ve Patients- Intensive
Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group.
Philadelphia -ve Patients- Intensive +
Patients in Belgium and the Netherlands with Philadelphia positive disease and who are fit for intensive treatment will be entered into this group
Philadelphia -ve Patients- Non Intensive
Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group
Registration only
Patients with either Philadelphia positive or negative ALL who do not wish to enter the study will be allocated to this group for data collection purposes only.

Detailed Description:

The study will

  1. establish baseline expectations for Event Free Survival (EFS), Overall Survival (OS), MRD responses and quality of life measures for older patients of all ages and pre-morbid states;
  2. disclose how best to use knowledge of pre-morbid characteristics to apply the appropriate intensity of therapy in order to balance the best disease related outcomes against quality of life;
  3. establish national standards of care for this patient group;
  4. provide the essential platform for careful design of future randomised advanced phase studies of new therapeutic approaches and agents.
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients over the age of 60 with acute lymphoblastic leukaemia.

Criteria

Inclusion Criteria:

  • Age ≥ 60 with Acute Lymphoblastic Leukaemia (ALL)
  • Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5-7 days may be given before trial registration))
  • Willing and able to give consent

Exclusion Criteria:

  • Known HIV infection
  • Blast transformation of CML
  • Mature B-cell leukaemia i.e. Burkitts disease t(8,14)(q24 ;q32) and variant c-myc translocations e.g. t(2;8)(p12 ;q24), t(8;22)(q24;q11)
  • Women who are pregnant or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616238

Contacts
Contact: UKALL60+ Trial Coordinator 0207 679 9860 ukall60@ctc.ucl.ac.uk

Sponsors and Collaborators
University College, London
Cancer Research UK
Stichting Hemato-Oncologie voor Volwassenen Nederland
  More Information

No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01616238     History of Changes
Other Study ID Numbers: UCL/11/0532
Study First Received: June 7, 2012
Last Updated: June 8, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014