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Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

NCT ID: NCT01474681

Last Updated: 2020-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-09

Study Completion Date

2016-10-03

Brief Summary

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

Detailed Description

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Conditions

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

Keywords

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hematologic malignancies leukemia lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HSC835

HSC835 infusion

Group Type EXPERIMENTAL

HSC835

Intervention Type BIOLOGICAL

Interventions

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HSC835

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=185

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

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CHSC835X2201

Identifier Type: -

Identifier Source: org_study_id