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Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia

This study is currently recruiting participants.
Verified May 2013 by Cellerant Therapeutics
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Cellerant Therapeutics
ClinicalTrials.gov Identifier:
NCT01297543
First received: February 11, 2011
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

Ex vivo expanded human myeloid progenitor cells (hMPCs; CLT-008) have the potential to accelerate neutrophil recovery and decrease the risk of febrile neutropenia and infection in patients receiving chemotherapy for acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic myeloid leukemia (CML), or high-risk myelodysplasia (MDS). In this study, the safety, tolerability and activity of CLT-008 administered after "standard of care" cytarabine-based consolidation or induction/re-induction chemotherapy will be determined by monitoring for adverse reactions, infusion reactions, graft-versus host disease (GVHD), neutrophil and platelet recovery, hMPC persistence, infections and complications.


Condition Intervention Phase
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Myeloid Leukemia
Myelodysplasia
 Biological: human myeloid progenitor cells
Drug: G-CSF
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cellerant Therapeutics:

Primary Outcome Measures:
  • Incidence of serious adverse reactions [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of neutropenia [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
  • Duration of thrombocytopenia [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
  • Duration of presence of CLT-008 derived cells in blood [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
  • Duration of presence of CLT-008 derived cells in bone marrow [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
  • Incidence of mucositis [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
  • Incidence of infections [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
  • Duration of fever [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
  • Duration of antibiotic use [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
  • Incidence of hospitalization [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]
  • Duration of hospitalization [ Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: March 2011
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Consolidation Group A
Low dose CLT-008 (human myeloid progenitor cells)
 Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
  • CLT-008
  • hMPC
Drug: G-CSF
Background therapy
Other Names:
  • filgrastim
  • granulocyte colony stimulating factor
Experimental: Consolidation Group B
Intermediate dose CLT-008 (human myeloid progenitor cells)
 Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
  • CLT-008
  • hMPC
Drug: G-CSF
Background therapy
Other Names:
  • filgrastim
  • granulocyte colony stimulating factor
Experimental: Consolidation Group C
Intermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF
 Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
  • CLT-008
  • hMPC
Experimental: Consolidation Group D
High dose CLT-008 (human myeloid progenitor cells)
 Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
  • CLT-008
  • hMPC
Drug: G-CSF
Background therapy
Other Names:
  • filgrastim
  • granulocyte colony stimulating factor
Active Comparator: Induction Group A1 (cytarabine 7+3)
G-CSF
 Drug: G-CSF
Background therapy
Other Names:
  • filgrastim
  • granulocyte colony stimulating factor
Experimental: Induction Group A2 (cytarabine 7+3)
Intermediate dose CLT-008 (human myeloid progenitor cells)
 Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
  • CLT-008
  • hMPC
Drug: G-CSF
Background therapy
Other Names:
  • filgrastim
  • granulocyte colony stimulating factor
Experimental: Induction Group A3 (cytarabine 7+3)
High dose CLT-008 (human myeloid progenitor cells)
 Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
  • CLT-008
  • hMPC
Drug: G-CSF
Background therapy
Other Names:
  • filgrastim
  • granulocyte colony stimulating factor
Active Comparator: Induction Group B1 (cytarabine HIDAC)
G-CSF
 Drug: G-CSF
Background therapy
Other Names:
  • filgrastim
  • granulocyte colony stimulating factor
Experimental: Induction Group B2 (cytarabine HIDAC)
Intermediate dose CLT-008 (human myeloid progenitor cells)
 Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
  • CLT-008
  • hMPC
Drug: G-CSF
Background therapy
Other Names:
  • filgrastim
  • granulocyte colony stimulating factor
Experimental: Induction Group B3 (cytarabine HIDAC)
High dose CLT-008 (human myeloid progenitor cells)
 Biological: human myeloid progenitor cells
Single intravenous injection/infusion
Other Names:
  • CLT-008
  • hMPC
Drug: G-CSF
Background therapy
Other Names:
  • filgrastim
  • granulocyte colony stimulating factor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Hematological malignancy, including:

    • AML, ALL or MDS
  • Planned treatment with cytarabine-based chemotherapy regimen
  • Adequate hepatic, renal, hematologic, cardiac and respiratory function

Key Exclusion Criteria:

  • Prior allograft or history of active GVHD within 3 years
  • Pregnant or nursing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297543

Contacts
Contact: Nancy Vinh 650-232-5433 nvinh@cellerant.com

Locations
United States, California
Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92037
Principal Investigator: Matthew Wieduwilt, MD, PhD            
University of California Medical Center Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Charalambos Andreadis, MD            
United States, Illinois
Loyola University Medical Center, Cardinal Bernardin Cancer Center Recruiting
Maywood, Illinois, United States, 60153
Principal Investigator: Danielle Shafer, DO            
United States, Indiana
Indiana Blood and Marrow Transplantation, LLC Recruiting
Beech Grove, Indiana, United States, 46107
Principal Investigator: Luke P Akard, MD            
United States, Massachusetts
University of Massachusetts Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Principal Investigator: Jan Cerny, MD            
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Celalettin Ustun, MD            
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Brian T Hill, MD, PhD            
United States, Pennsylvania
The Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Principal Investigator: James Rossetti, DO            
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Farhad Ravandi-Kashani, MD            
Sponsors and Collaborators
Cellerant Therapeutics
Department of Health and Human Services
  More Information

Additional Information:
Cellerant Therapeutics, Inc.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Cellerant Therapeutics
ClinicalTrials.gov Identifier: NCT01297543     History of Changes
Other Study ID Numbers: CLT008-02
Study First Received: February 11, 2011
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cellerant Therapeutics:
Induction chemotherapy
Re-induction chemotherapy
Consolidation chemotherapy
Leukemia
Myelodysplasia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013