E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with AML, MDS, ALL, CML in accelerated phase or blastic transformation, CLL, MM or aggressive lymphoma, who underwent a (non) myeloablative allo-SCT with an unrelated donor. |
Patienten met AML, MDS, ALL, CML in geaccelereerde fase of blastische transformatie, CLL, MM of agressief lymfoom, die een (non) myeloablatieve allo-SCT met een onverwante donor hebben ondergaan. |
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E.1.1.1 | Medical condition in easily understood language |
Hematological malignant diseases |
hematologische kwaadaardige aandoeningen |
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E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10007838 |
E.1.2 | Term | CD4 lymphocytes |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 evaluate whether CD4+ lymphocytes infusion given three months after T-cell depleted allogeneic stem cell transplantation (allo-SCT) improves immunological recovery (by increasing the number of circulating naïve CD4+ lymphocytes) |
- Evalueren of CD4 lymfocyteninfusie, gegeven op drie maanden na T-cel gedepleteerde allogene stamceltransplantatie, een verbeterde immuunreconstitutie geeft |
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E.2.2 | Secondary objectives of the trial |
• To evaluate whether CD4+ lymphocytes infusion given three months after T-cell depleted allogeneic stem cell transplantation (allo-SCT) increases donor chimerism in B and T lymphocyte compartment (lineage specific chimerism).
• To evaluate the effects of CD4+ lymphocytes infusion on the incidence of transplantation related complications during the first year after the transplantation. Transplantation related complications are defined as:
o CMV disease or CMV reactivation needing systemic treatment
o EBV reactivation needing systemic treatment
o VZV infection
o Other infections for which hospitalization is needed
o GVHD needing systemic treatment
o Auto-immune disorders needing systemic treatment.Please enter information in English and add any other language that is applicable |
- evalueren of CD4 lymfocyten infusie, gegeven op 3 maanden na allogene stamceltransplantatie, een verhoging van donor chimerisme in B en T lymfocyten geeft
- Evalueren wat de effecten van CD4 lymfocyten infusie op de incidentie van transplantatie gerelateerde complicaties gedurende de het eerste jaar na de transplantatie zijn. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age > 18 years
• Patients with AML, myelodysplasia , ALL, CML in accelerated phase or blastic transformation, CLL, MM or (non) Hodgkin lymphoma, who are definitely planned to undergo an allo-SCT with an unrelated donor who is matched for HLA-A, B, C, DR and DQ.
• Life expectation of > 3 months
• WHO performance status of 0, 1 or 2
• Written informed consent according to the rules and regulations of the Leiden University Medical Center. |
- > 18 jaar
- Patienten met AML, MDS, ALL, CML in geaccelereerde fase of blastische transformatie, CLL, MM of (non) Hodgkin lymfoom, die een allo-SCT zullen ondergaan met een 10/10 gematchte onverwante donor die gematched is voor HLA-A, B, C, DR en DQ.
- levensverwachting van > 3 maanden
- WHO performance status van 0, 1 of 2
- Schriftelijk informed consent |
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E.4 | Principal exclusion criteria |
• Use of systemic immunosuppressive treatment (due to GVHD)
• Acute GVHD of the skin > grade 2 or progressive acute GVHD
• Progressive disease needing cytoreductive treatment
• Any concomitant disease preventing the safe administration of donor lymphocytes
• Severe psychological disturbances
• Severely limited life expectation due to diseases other than the malignancy
• Very high risk disease preceding allo-SCT for which already unselected DLI is planned to be given 3 months after allo-SCT. |
- Gebruik van systemische immunosuppressieve behandeling
- Acute GVHD van de huid; >graad 2 of progressieve acute GVHD
- progressieve ziekte waarvoor cytoreductieve behandeling nodig is
- een bijkomende ziekte die een veilige toediening van donor lymfocyten in de weg staat
- ernstige psychologische afwijking
- Zeer hoog risicp ziekte na de allo-SCT waarvoor reeds een ongeselecteerde DLI gepland staat op 3 maanden na allo-SCT |
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E.5 End points |
E.5.1 | Primary end point(s) |
• The number of circulating naïve CD4+ lymphocytes 4.5 months after allo-SCT. |
- het aantal circulerende naieve CD4 lymfocyten, 4,5 maanden na allo-sct |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
4.5 months after allo-SCT |
4.5 maand na allo-SCT |
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E.5.2 | Secondary end point(s) |
- Lymphocyte chimerism status
- Transplantation related complications between 3 and 12 months after the transplantation (CMV disease or CMV reactivation needing systemic treatment, EBV reactivation needing systemic treatment, VZV infection, other infections for which hospitalization, GVHD needing systemic treatment, auto-immune disorders needing systemic treatment). |
- lymfocyten chimerisme status
- transplantatiegerelateerde complicaties tussen 3 en 12 maanden na transplantatie |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- 14, 20 and 26 weeks after allo-SCT
- 9, 12, 15, 18, 21, 24, 30, 36 months after allo-SCT |
- 14, 20 en 26 weken na allo-SCT
- 9, 12, 15, 18, 21, 24, 30, 36 maanden na allo-SCT |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 |
ongeselecteerde donor lymfocyten infusie |
Unselected Donor lymphocyte infusion |
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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
| 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
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last visit of last subject in the trial |
laatste follow-up bezoek van laatste patient in de studie |
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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 | 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 |