Clinical trial NCT01297543: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Myeloid Leukemia
Myelodysplasia
Keywords: Induction chemotherapy
Re-induction chemotherapy
Consolidation chemotherapy
Leukemia
Myelodysplasia
Lead sponsor: Cellerant Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2011-02-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Incidence of serious adverse reactions
timeFrame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Secondary outcomes:
measure: Duration of neutropenia
timeFrame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
measure: Duration of thrombocytopenia
timeFrame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
measure: Duration of presence of CLT-008 derived cells in blood
timeFrame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
measure: Duration of presence of CLT-008 derived cells in bone marrow
timeFrame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
measure: Incidence of mucositis
timeFrame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
measure: Incidence of infections
timeFrame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
measure: Duration of fever
timeFrame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
measure: Duration of antibiotic use
timeFrame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
measure: Incidence of hospitalization
timeFrame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
measure: Duration of hospitalization
timeFrame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center, Cardinal Bernardin Cancer Center
state: Illinois
city: Beech Grove
country: United States
facility: Indiana Blood and Marrow Transplantation, LLC
state: Indiana
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: The Western Pennsylvania Hospital
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: