Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Marginal Zone Lymphoma; Chronic Myelogenous Leukemia; Mantle-cell Lymphoma; Lymphoplasmacytic Lymphoma; Burkitt's Lymphoma; Large-cell Lymphoma; Acute Myelocytic Leukemia; Acute Lymphocytic Leukemia; High Grade Lymphomas; Lymphoblastic Lymphoma; Follicular Lymphomas; Chronic Lymphocytic Leukemia; Myelodysplastic Syndrome

Treatments: Biological: HSC835

Study type: Interventional

Funder types: Industry

Identifiers

NCT01474681

CHSC835X2201

Details and patient eligibility

About

This study evaluated the safety and tolerability of using HSC835 in patients with hematological malignancies.

Enrollment: 27 patients

Sex: All

Ages: 10 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis that qualifies them for a DUCBT
• Absence of recent active mold infection
• Adequate organ function
• Availability of eligible donor material

Exclusion criteria

• Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used
• Human immunodeficiency virus (HIV) infection
• Active infection
• Extensive prior chemotherapy
• Prior myeloablative allotransplantation or autologous transplant.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

HSC835

Experimental group

Description:

HSC835 infusion

Treatment:

Biological: HSC835