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

Primary Purpose

Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
human myeloid progenitor cells
G-CSF
Sponsored by
Cellerant Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Myeloid Leukemia focused on measuring Induction chemotherapy, Re-induction chemotherapy, Consolidation chemotherapy, Leukemia, Myelodysplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moores UCSD Cancer Center
  • University of California San Francisco Medical Center
  • Stanford Hospital and Clinics
  • Loyola University Medical Center, Cardinal Bernardin Cancer Center
  • Indiana Blood and Marrow Transplantation, LLC
  • University of Massachusetts Memorial Medical Center
  • University of Minnesota
  • Cleveland Clinic
  • The Western Pennsylvania Hospital
  • The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Consolidation Group A

Consolidation Group B

Consolidation Group C

Consolidation Group D

Induction Group A1 (cytarabine 7+3)

Induction Group A2 (cytarabine 7+3)

Induction Group A3 (cytarabine 7+3)

Induction Group B1 (cytarabine HIDAC)

Induction Group B2 (cytarabine HIDAC)

Induction Group B3 (cytarabine HIDAC)

Arm Description

Low dose CLT-008 (human myeloid progenitor cells)

Intermediate dose CLT-008 (human myeloid progenitor cells)

Intermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF

High dose CLT-008 (human myeloid progenitor cells)

G-CSF

Intermediate dose CLT-008 (human myeloid progenitor cells)

High dose CLT-008 (human myeloid progenitor cells)

G-CSF

Intermediate dose CLT-008 (human myeloid progenitor cells)

High dose CLT-008 (human myeloid progenitor cells)

Outcomes

Primary Outcome Measures

Incidence of serious adverse reactions

Secondary Outcome Measures

Duration of neutropenia
Duration of thrombocytopenia
Duration of presence of CLT-008 derived cells in blood
Duration of presence of CLT-008 derived cells in bone marrow
Incidence of mucositis
Incidence of infections
Duration of fever
Duration of antibiotic use
Incidence of hospitalization
Duration of hospitalization

Full Information

First Posted
February 11, 2011
Last Updated
June 29, 2016
Sponsor
Cellerant Therapeutics
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT01297543
Brief Title
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
Official Title
A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellerant Therapeutics
Collaborators
Department of Health and Human Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Myelodysplasia
Keywords
Induction chemotherapy, Re-induction chemotherapy, Consolidation chemotherapy, Leukemia, Myelodysplasia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Consolidation Group A
Arm Type
Experimental
Arm Description
Low dose CLT-008 (human myeloid progenitor cells)
Arm Title
Consolidation Group B
Arm Type
Experimental
Arm Description
Intermediate dose CLT-008 (human myeloid progenitor cells)
Arm Title
Consolidation Group C
Arm Type
Experimental
Arm Description
Intermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF
Arm Title
Consolidation Group D
Arm Type
Experimental
Arm Description
High dose CLT-008 (human myeloid progenitor cells)
Arm Title
Induction Group A1 (cytarabine 7+3)
Arm Type
Active Comparator
Arm Description
G-CSF
Arm Title
Induction Group A2 (cytarabine 7+3)
Arm Type
Experimental
Arm Description
Intermediate dose CLT-008 (human myeloid progenitor cells)
Arm Title
Induction Group A3 (cytarabine 7+3)
Arm Type
Experimental
Arm Description
High dose CLT-008 (human myeloid progenitor cells)
Arm Title
Induction Group B1 (cytarabine HIDAC)
Arm Type
Active Comparator
Arm Description
G-CSF
Arm Title
Induction Group B2 (cytarabine HIDAC)
Arm Type
Experimental
Arm Description
Intermediate dose CLT-008 (human myeloid progenitor cells)
Arm Title
Induction Group B3 (cytarabine HIDAC)
Arm Type
Experimental
Arm Description
High dose CLT-008 (human myeloid progenitor cells)
Intervention Type
Biological
Intervention Name(s)
human myeloid progenitor cells
Other Intervention Name(s)
CLT-008, hMPC
Intervention Description
Single intravenous injection/infusion
Intervention Type
Drug
Intervention Name(s)
G-CSF
Other Intervention Name(s)
filgrastim, granulocyte colony stimulating factor
Intervention Description
Background therapy
Primary Outcome Measure Information:
Title
Incidence of serious adverse reactions
Time Frame
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Secondary Outcome Measure Information:
Title
Duration of neutropenia
Time Frame
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Title
Duration of thrombocytopenia
Time Frame
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Title
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
Title
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
Title
Incidence of mucositis
Time Frame
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Title
Incidence of infections
Time Frame
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Title
Duration of fever
Time Frame
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Title
Duration of antibiotic use
Time Frame
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Title
Incidence of hospitalization
Time Frame
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Title
Duration of hospitalization
Time Frame
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Loyola University Medical Center, Cardinal Bernardin Cancer Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana Blood and Marrow Transplantation, LLC
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cellerant.com
Description
Cellerant Therapeutics, Inc.

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

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