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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297543
• Other study ID #: CLT008-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 11, 2011
• Last updated: June 29, 2016
• Start date: March 2011
• Est. completion date: January 2015

Study information

• Verified date: June 2016
• Source: Cellerant Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplasia
• Myelodysplastic Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Intervention

Biological:
• human myeloid progenitor cells
Single intravenous injection/infusion

Drug:
• G-CSF
Background therapy

Locations

Country	Name	City	State
United States	Indiana Blood and Marrow Transplantation, LLC	Beech Grove	Indiana
United States	Cleveland Clinic	Cleveland	Ohio
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Moores UCSD Cancer Center	La Jolla	California
United States	Loyola University Medical Center, Cardinal Bernardin Cancer Center	Maywood	Illinois
United States	University of Minnesota	Minneapolis	Minnesota
United States	The Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	University of California San Francisco Medical Center	San Francisco	California
United States	Stanford Hospital and Clinics	Stanford	California
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Cellerant Therapeutics	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse reactions		Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose	Yes
Secondary	Duration of neutropenia		Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose	No
Secondary	Duration of thrombocytopenia		Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose	No
Secondary	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	No
Secondary	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	No
Secondary	Incidence of mucositis		Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose	No
Secondary	Incidence of infections		Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose	No
Secondary	Duration of fever		Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose	No
Secondary	Duration of antibiotic use		Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose	No
Secondary	Incidence of hospitalization		Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose	No
Secondary	Duration of hospitalization		Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose	No

External Links

•   Cellerant Therapeutics, Inc.