Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia
1 other identifier
interventional
45
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2011
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 16, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJuly 1, 2016
June 1, 2016
3.7 years
February 11, 2011
June 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of serious adverse reactions
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Secondary Outcomes (10)
Duration of neutropenia
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of thrombocytopenia
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
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
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of mucositis
Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
- +5 more secondary outcomes
Study Arms (10)
Consolidation Group A
EXPERIMENTALLow dose CLT-008 (human myeloid progenitor cells)
Consolidation Group B
EXPERIMENTALIntermediate dose CLT-008 (human myeloid progenitor cells)
Consolidation Group C
EXPERIMENTALIntermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF
Consolidation Group D
EXPERIMENTALHigh dose CLT-008 (human myeloid progenitor cells)
Induction Group A1 (cytarabine 7+3)
ACTIVE COMPARATORG-CSF
Induction Group A2 (cytarabine 7+3)
EXPERIMENTALIntermediate dose CLT-008 (human myeloid progenitor cells)
Induction Group A3 (cytarabine 7+3)
EXPERIMENTALHigh dose CLT-008 (human myeloid progenitor cells)
Induction Group B1 (cytarabine HIDAC)
ACTIVE COMPARATORG-CSF
Induction Group B2 (cytarabine HIDAC)
EXPERIMENTALIntermediate dose CLT-008 (human myeloid progenitor cells)
Induction Group B3 (cytarabine HIDAC)
EXPERIMENTALHigh dose CLT-008 (human myeloid progenitor cells)
Interventions
Single intravenous injection/infusion
Background therapy
Eligibility Criteria
You may qualify if:
- Hematological malignancy, including:
- AML, ALL or MDS
- Planned treatment with cytarabine-based chemotherapy regimen
- Adequate hepatic, renal, hematologic, cardiac and respiratory function
You may not qualify if:
- Prior allograft or history of active GVHD within 3 years
- Pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cellerant Therapeuticslead
- Department of Health and Human Servicescollaborator
Study Sites (10)
Moores UCSD Cancer Center
La Jolla, California, 92037, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Loyola University Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153, United States
Indiana Blood and Marrow Transplantation, LLC
Beech Grove, Indiana, 46107, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2011
First Posted
February 16, 2011
Study Start
March 1, 2011
Primary Completion
November 1, 2014
Study Completion
January 1, 2015
Last Updated
July 1, 2016
Record last verified: 2016-06