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

June 29, 2016 updated by: Cellerant Therapeutics

A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Moores UCSD Cancer Center
      • San Francisco, California, United States, 94143
        • University of California San Francisco Medical Center
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center, Cardinal Bernardin Cancer Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Indiana Blood and Marrow Transplantation, LLC
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • The Western Pennsylvania Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious adverse reactions
Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of neutropenia
Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of thrombocytopenia
Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
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
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
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
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of mucositis
Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of infections
Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of fever
Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of antibiotic use
Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of hospitalization
Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of hospitalization
Time Frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellerant Therapeutics

Collaborators

Department of Health and Human Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 15, 2011

First Posted (ESTIMATE)

February 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 1, 2016

Last Update Submitted That Met QC Criteria

June 29, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLT008-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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