E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute myeloid or acute lymphoblastic leukaemia |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000880 |
E.1.2 | Term | Acute myeloid leukaemia |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000844 |
E.1.2 | Term | Acute lymphoblastic leukaemia |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to determine whether adoptive immunotherapy with CD25/71 allodepleted donor T-cells can be safely used to improve T-cell reconstitution after unrelated donor SCT. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient inclusion criteria: 1. Age ≥16 years 2. Underlying acute myeloid or acute lymphoblastic leukaemia 3. Planned allogeneic peripheral blood stem cell transplantation from a 9/10 or 10/10 HLA-matched unrelated donor, using an Alemtuzumab-based conditioning protocol 4. Written Informed consent
Donor inclusion criteria: 1. Donors must be unrelated to and HLA-matched (10/10) or a single antigenic/allelic mismatch with the recipient (9/10) 2. Donors must be healthy and pass a medical examination determining they are fit to donate peripheral blood stem cells 3. Donors must sign an informed consent form indicating that they are aware their additional donation of peripheral blood or leucapheresis is for research purposes
|
|
E.4 | Principal exclusion criteria |
Patient exclusion criteria: 1.Life expectancy < 6 weeks 2. Female patients who are pregnant and lactating 3. Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT
Donor exclusion criteria: 1. Donor registry determines contraindication to donate mobilised peripheral blood stem cells, 500ml peripheral blood draw or unstimulated leucapheresis for generation of PBMC.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Circulating CD3 count at 4 months post-SCT |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From date of transplant to 4 months post transplant |
|
E.5.2 | Secondary end point(s) |
1.Incidence of grade II-IV acute and chronic graft versus host disease (GVHD) 2.Time to recovery of normal T-cell (>700/μL) and CD4 (>300/μL) counts and normal T-cell receptor (TCR) diversity as assessed by VB spectratyping 3.In vitro anti-viral responses of circulating peripheral blood mononuclear cells (PBMCs) 4.Transplant related mortality and disease-free survival at 1 year post-SCT
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The incidence of GVHD will be assessed in follow-up visits to clinic until 12 months post-SCT. TRM and DFS will be analysed until 1 year post-transplant through regular visits to clinic. The immunological end points will be assessed from peripheral blood samples obtained monthly until 6 months post-transplant and then bi-monthly until 1 year post-SCT. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of trial will be 1 year after the last registered patient undergoes SCT (at which time they will have completed follow-up) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |