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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01297543

Enrollment

Registered

2011-02-16

Start date

2011-03-31

Completion date

2015-01-31

Last updated

2016-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Myelodysplasia

Keywords

Induction chemotherapy, Re-induction chemotherapy, Consolidation chemotherapy, Leukemia, Myelodysplasia

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.

Interventions

BIOLOGICALhuman myeloid progenitor cells

Single intravenous injection/infusion

DRUGG-CSF

Background therapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026