Donation of enriched donor T-cells after stem cell transplantation, which are specificly directed against multiple target structures and which confer protection against viral infections and anti-leukemic activity against leukemia cells.

• Conditions: patients with hematological malignancies after T cell depleted allo-SCT; MedDRA version: 18.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: PTClassification code 10000846Term: Acute lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: PTClassification code 10028576Term: Myeloproliferative disorderSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: LLTClassification code 10025311Term: Lymphoma (non-Hodgkin's)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: PTClassification code 10035226Term: Plasma cell myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2014-003171-39-DE
• Lead Sponsor: niversity Hospital Wuerzburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-17
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male or female patients with planned T-cell depleted allo-SCT aged >= 18 with AML in first CR
Male or female patients with planned T-cell depleted allo-SCT aged >60 years or pa-tients 18-60 years with comorbidity score (Sorror) >3 with one of these diagnoses:
- Acute Lymphoblastic Leukemia in CR after prephase and first induction and consolidation therapy and WBC < 30 x 109/l in B-ALL or < 100 x 109/l in T-ALL at initial diagnosis. ALL with t(9;22), t(4;11), complex karyotype or 11q23 abnormalities will be excluded.
- Acute Myeloid Leukemia in CR or blast free aplasia
- Multiple myeloma at least in stable PR (no treatment foreseen in first 6 months after allo-SCT)
- Non high grade B-NHL (B-CLL, Mantle cell lymphoma, Follicular Lymphoma, MALT, LPL) at least in stable PR (no treatment foreseen in first 6 months after allo-SCT)
- Myeloprolypherative disorder at least in stable PR (no treatment foreseen in first 6 months after allo-SCT), excluding CML blastic phase
- Myelodysplastic syndrome at least in stable PR (no treatment foreseen in first 6 months after allo-SCT)
HLA type A*0201.
Written informed consent of the patient
Availability of a stem cell donor who meets the following inclusion criteria:
-HLA type A*0201
-CMV and/ or EBV seropositivity
-Negative HIV testing (negartivity for viral infections such as hepatitis B or others are are not required, as long as a transplant indication is given)
-Written informed consent of donor

Inclusion criteria after allo-SCT: Stable engraftment of the allogeneic graft (platelets >20 *109/L, granulocytes > 0.5 *109/L)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

Exclusion Criteria before allo-SCT:
Disease specific treatment foreseen in the first 6 months after SCT
Pregnant or lactating women.
Severe psychological disturbances.
Life expectation < 12 weeks.
End stage irreversible multi-system organ failure
Forseen participation in another clinical trial during or within 4 weeks before study en-try

Exclusion Criteria after allo-SCT:
Disease specific treatment foreseen in the first 6 months after SCT
Pregnant or lactating women.
Severe psychological disturbances.
Histologically proven acute GVHD > grade I for which immune suppressive treatment is given
Progressive disease for which therapy is needed
Use of > 20 mg prednisone a day
Life expectation < 12 weeks.
End stage irreversible multi-system organ failure
Participation in another clinical trial during or within 4 weeks before study entry

Exclusion criteria at time of infusion of multiantigen-specific T cells:
Acute GVHD (preferentially histologically proven) GVHD > grade I for which immune
suppressive treatment is given
Progressive disease for which therapy is needed
Use of > 20 mg prednisone a day
Life expectation < 12 weeks.
End stage irreversible multi-system organ failure
Uncontrolled bacterial or fungal infection.
Evidence of rejection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified