Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells

Eberhard Karls University of Tübingen

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Childhood Solid Tumor; Acute Leukemias; Aplastic Anemia

Treatments: Other: Transplantation of CD3/CD19 depleted stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01919866

1075/01 PEI

Details and patient eligibility

About

Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with primary refractory or relapsed disease (including relapse after previous SCT and active disease)
• AML in complete remission of refractory
• MDS RAEB-t/secondary AML
• ALL
• CML
• Non-Hodgkin Lymphoma / Hodgkin Lymphoma
• non malignant diseases (aplastic anemia, thalassemia, SCID)
• relapsed Neuroblastoma
• relapsed soft tissue sarcoma (Rhabdomyosarcoma, Ewing sarcoma, PNET
• soft tissue sarcoma with primary bone metastases or bone marrow
• in whom no matched donor was available,

Exclusion criteria

• < 6 months after previous HSCT
• active cerebral seizure conditions
• massive progression of leukemias or solid tumours before planned trp.
• left ventricular ejection fraction <25%
• creatinine clearance <40ml/min before conditioning
• respiratory insufficiency with oxygen demand or DLCO <30%
• Bilirubin >4mg/dl, GOT/GPT >400
• severe infection (HIV, Aspergillosis)
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Transplantation of CD3/CD19 depleted stem cells

Experimental group

Description:

Patients receive a minimum dosage of 10x10E6/kg bodyweight CD3/CD19 depleted CD34+ stem cells. Maximum dosage of residual T cells will be 1x10E5/kg BW

Treatment:

Other: Transplantation of CD3/CD19 depleted stem cells