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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


Phase 1/Phase 2
10 Years
55 Years
Open (Enrolling)
Both
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

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability: Safety and tolerability will be measured by occurrence of infusional toxicity or occurrence of graft failure

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CHSC835X2201

NCT ID:

NCT01474681

Start Date:

January 2012

Completion Date:

December 2014

Related Keywords:

  • 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
  • hematologic malignancies
  • leukemia
  • lymphoma
  • Burkitt Lymphoma
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell
  • Hematologic Neoplasms

Name

Location
Novartis Investigative Site Minneapolis, Minnesota  55455