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Completed

NCT Number: NCT01474681

Safety and Tolerability of HSC835 in Patients With Hematological Malignancies

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

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Key information

Conditions

Acute Myelocytic Leukemia Acute Lymphocytic Leukemia Bone Marrow Diseases Burkitt Lymphoma Burkitt's Lymphoma Chronic Disease Chronic Lymphocytic Leukemia Chronic Myelogenous Leukemia DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Disease Attributes Epstein-Barr Virus Infections Follicular Lymphomas Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Herpesviridae Infections High Grade Lymphomas Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Infections Large-cell Lymphoma Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoblastic Lymphoma Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoplasmacytic Lymphoma Lymphoproliferative Disorders Mantle-Cell Lymphoma Marginal Zone Lymphoma Myelodysplastic Syndrome Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Tumor Virus Infections Virus Diseases

Age range

10 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigative Site

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HSC835

Biological

Primary outcomes

  1. 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.

    Time frame: 32 days

    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.

Secondary outcomes

  1. Incidence of Neutrophil Recovery Within 42 Days

    Time frame: 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.

  2. Incidence of Platelet Recovery Within Six Months

    Time frame: 6 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.

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

    Time frame: Day 100

    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

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

    Time frame: Day 100 and Month 12

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

  5. 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

    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

  6. Incidence of Relapse Within One Year

    Time frame: Month 12

    Number of participants with Incidence of relapse within one year

  7. Overall Survival (OS) Within One Year

    Time frame: Month 12

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

  8. Disease Free Survival (DFS) Within One Year

    Time frame: Month 12

    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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A First-in-human, Single-arm, Single-center, Open-label, Proof-of-concept Study to Evaluate the Safety and Tolerability of Infusing HSC835 (LFU835-expanded Umbilical Cord Blood Hematopoietic Stem Cells) in Patients With Hematological Malignancies

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2011
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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