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

University College London (UCL)

Status and phase: Completed; Phase 2

Conditions: Acute Lymphoblastic Leukaemia

Treatments: Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01616238

UCL/11/0532

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 60 with Acute Lymphoblastic Leukaemia (ALL) OR ≥ 55 with Acute Lymphoblastic Leukaemia (ALL) unsuitable for the UKALL14 or HOVON 100 trial
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 5 patient groups

Philadelphia Positive Patients

Experimental group

Description:

All patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen

Treatment:

Drug: Chemotherapy

Philadelphia -ve Patients- Intensive

Experimental group

Description:

Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group.

Treatment:

Drug: Chemotherapy

Philadelphia -ve Patients- Intensive +

Experimental group

Description:

Patients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group

Treatment:

Drug: Chemotherapy

Philadelphia -ve Patients- Non Intensive

Experimental group

Description:

Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group

Treatment:

Drug: Chemotherapy

Registration only

No Intervention group

Description:

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.