Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

Phase 2CompletedNCT01474681

Novartis Pharmaceuticals27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myelocytic Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Myelodysplastic Syndrome Chronic Lymphocytic Leukemia Marginal Zone Lymphoma

Eligibility

Sex: ALLMin age: 10 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT.

The safety and tolerability of HSC835 for clinical use were measured by infusional toxicity and absence of graft failure in excess of that currently observed with UCBT. Infusional toxicity - AE from transplant until first 48 hours. Administration of the HSC835 expanded CD34-positive cell product, infused over a period of approximately 15 minutes may theoretically cause adverse reactions based on hemodynamic effects, the release of factors like cytokines through administration into the systemic circulation, or acute hypersensitivity, among others.

Time frame: 32 days

Secondary Outcomes

Incidence of Neutrophil Recovery Within 42 Days

Neutrophil recovery (engraftment) is defined as the first of three consecutive days with ANC \> 0.5 x 109/L which occurred for all patients before 42 days post transplant.

Time frame: 42 days

Incidence of Platelet Recovery Within Six Months

Incidence of platelet recovery within six months. Number of participants recovering platelet to ≥50,000 × 109/L for at least one week without transfusion in the prior 7 days to the first measurement.

Time frame: 6 months

Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only)

Frequency of expanded unit predominance at day 100 (DUCBT recipients only) unit predominance was assessed by differences in microsatellite patterns between the recipient, HSC835 and the unmanipulated cord blood unit. Evaluation of sorted CD15-positive/CD33-positive myeloid and CD3-positive T cells in the peripheral blood, revealed three patterns: predominance of HSC835, Mixed dominance an unique chimerism pattern was observed with the CD15/CD33 population predominantly derived from HSC835 and the CD3 population almost exclusively derived from the unmanipulated unit, and predominance of the unmanipulated unit

Time frame: Day 100

Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year

Number of participants with incidence of transplant related mortality (TRM) within 100 days and one year

Time frame: Day 100 and Month 12

Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year

Number of participants with incidence of Acute Graft Versus Host Disease (aGVHD) within 100 days and Chronic Graft Versus Host Disease (cGVHD) within 1 year

Time frame: Day 100 and Monnth 12

Incidence of Relapse Within One Year

Number of participants with Incidence of relapse within one year

Time frame: Month 12

Overall Survival (OS) Within One Year

Number of participants with Overall survival (OS) within one year

Time frame: Month 12

Disease Free Survival (DFS) Within One Year

Number of participants with Disease Free Survival (DFS) within one year. Patients are considered to have achieved DFS or relapse-free survival if they had not experienced either relapse or death (of any cause)

Time frame: Month 12

Data from ClinicalTrials.gov

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Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes