Chronic lymphocytic leukaemia (CLL) unrelated and related allogeneic transplantation in very high risk disease for leukaemia eradication trial

A phase III study on the value of allogeneic stem cell transplantation in poor-risk chronic lymphocytic leukaemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87956640

Enrollment

206

Registered

2009-11-05

Start date

2010-01-01

Completion date

Unknown

Last updated

2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk and very high-risk chronic lymphocytic leukaemia (CLL) Cancer Lymphoid leukaemia

Interventions

Stratum 1: Patients achieving complete remission (CR)/partial remission (PR) after three cycles of salvage and having an HLA-identical donor at 3 months landmark (LM) are randomised 1:1 to RIC allo-SC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 - 65 years, either sex 2. World Health Organization performance status (WHO PS) grade 0 - 1 3. Active and measurable high risk CLL (Stratum 1) or very high risk CLL (Stratum 2)

Exclusion criteria

Exclusion criteria: 1. Patients unable to withstand RIC allo-SCT 2. Participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
EFS 2 years after randomisation, in comparison with conventional treatment.	—

Secondary

Measure	Time frame
Measured at patient recruitment and then at 12 and 24 months after randomisation: 1. 5-year overall survival (OS) from randomisation; 5-year OS from registration (Stratum 2 only) 2. Clinical response 3. Safety from any cause 4. Non-relapse mortality 5. Morbidity 6. Chronic graft-versus-host disease 7. Quality of life, measured using the EORTC questionnaire	—

Countries

Austria, Canada, Germany, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026