E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Low grade, intermediate and high grade non Hodgkin lymphoma (NHL), M.Hodgkin, Chronic Lymphocytic Leukemia (CLL), Chronic Myeloid Leukemia (CML), Acute Lymphoblastic Leukemia (ALL), Myelodysplasia (MDS). |
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E.1.1.1 | Medical condition in easily understood language |
Hematological malignacy, cancers of the blood, bone marrow and lymphatic organs. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 |
The objective of the study is to improve the T cell killing by treating the patient with in the laboratory cultured professional antigen presenting cells (DCs) which are loaded with specific antigens that are only present on blood and cancer cells of the patient (hematopoietic restricted) and absent on the healthy organ cells of the patient.
Primary endpoints are toxicity and efficacy |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are the effect of mHag vaccination on the immune status of the patient |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with low grade, intermediate and high grade non Hodgkin lymphoma (NHL), M.Hodgkin, Chronic Lymphocytic Leukemia (CLL), Chronic Myeloid Leukemia (CML), Acute Lymphoblastic Leukemia (ALL), Myelodysplasia (MDS) and proven residual disease (including as determined by disease specific of patient specific PCR) minimally 6 months after Allogeneic Stem Cell transplantation (Allo-SCT) and subsequent persistent disease after a first pre-emptive DLI or patients with relapsed haematological disease after Allo-SCT and persistent disease after a first therapeutic DLI. |
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E.4 | Principal exclusion criteria |
1. WHO performance 3-4
2. Presence of severe cardiac hepatic, renal, metabolic disease
3. Rapidly progressive disease
4. No measurable disease
5. Life expectancy > 3 months
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints are the evaluation of safety and efficacy, the occurance of GvHD and the induction of a positive response to the combined DLI and DC treatment
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Timepoints are during the infusion period every two weeks. After the infusion every 4 weeks untill progression or reaching the stopping rules |
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E.5.2 | Secondary end point(s) |
The secondary endpoint is the effect of mHag vaccination on the immune status of the patient including the development of specific mHag responses |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoints are during the infusion period every two weeks. After the infusion every 4 weeks untill progression or reaching the stopping rules |
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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) | Yes |
E.7.1.1 | First administration to humans | Yes |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 3 |
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 | Yes |
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
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The trial will end after treatment of 30 patients which is expected 3 years after start of the study |
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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 |