E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement |
|
E.1.1.1 | Medical condition in easily understood language |
mature B cell neoplasm with blood and/or bone marrow involvement |
rijpcellig B-cel neoplasie met bloed en/of beenmerg betrokkenheid |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
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 |
- To investigate the feasibility and safety of administration of donor leukemia-reactive T cells. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the persistence of leukemia-reactive T cells after administration.
- To evaluate whether administration of leukemia-reactive T cells leads to complete remission (CR), partial remission (PR) or mixed response (MR) within 12 weeks after last infusion.
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|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- allo-SCT patient with a sibling or unrelated stem cell donor matched for at least HLA-A, -B, -C, and –DR alleles (8/8).
- Age 18-75 years.
- WHO performance score 0-2.
- Persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement at least 3 months after allo-SCT or DLI.
- Possibility to collect > 5 x 10^7 mononuclear cells containing > 25% malignant B cells from blood or bone marrow of patient, or availability of patient malignant B cells cryopreserved at a GMP-facility.
- Donor willing to donate PBMC, or cryopreserved donor PBMC available in an amount of ≥1 x 10^9 MNC/ total.
- Written informed consent |
|
E.4 | Principal exclusion criteria |
- Life expectation < 3 months.
- End stage irreversible multi-system organ failure.
- Acute GvHD overall grade ≥ II.
- Treatment with corticosteroids in an equivalent dose of >0.5 mg/kg prednisone.
- Pregnant or lactating women.
- Severe psychological disturbances. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- The number of acute GvHD, other serious adverse events and deaths within 12 weeks after last infusion of leukemia-reactive T cells.
- The feasibility of generation of leukemia-reactive T cells for administration. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
- weekly until 12 weeks after last infusion |
|
E.5.2 | Secondary end point(s) |
- Increase in number of leukemia-reactive T cells in blood and/or bone marrow at different time points after infusion of leukemia-reactive T cells.
- CR, PR and MR rate 12 weeks after last infusion of leukemia-reactive T cells.
- Time to next leukemia/lymphoma treatment. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- weekly until 12 weeks after last infusion |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
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 |