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

Cellerant Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Myelodysplasia; Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

Treatments: Drug: G-CSF; Biological: human myeloid progenitor cells

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01297543

CLT008-02

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 10 patient groups

Consolidation Group A

Experimental group

Description:

Low dose CLT-008 (human myeloid progenitor cells)

Treatment:

Biological: human myeloid progenitor cells

Drug: G-CSF

Consolidation Group B

Experimental group

Description:

Intermediate dose CLT-008 (human myeloid progenitor cells)

Treatment:

Biological: human myeloid progenitor cells

Drug: G-CSF

Consolidation Group C

Experimental group

Description:

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

Treatment:

Biological: human myeloid progenitor cells

Consolidation Group D

Experimental group

Description:

High dose CLT-008 (human myeloid progenitor cells)

Treatment:

Biological: human myeloid progenitor cells

Drug: G-CSF

Induction Group A1 (cytarabine 7+3)

Active Comparator group

Description:

G-CSF

Treatment:

Drug: G-CSF

Induction Group A2 (cytarabine 7+3)

Experimental group

Description:

Intermediate dose CLT-008 (human myeloid progenitor cells)

Treatment:

Biological: human myeloid progenitor cells

Drug: G-CSF

Induction Group A3 (cytarabine 7+3)

Experimental group

Description:

High dose CLT-008 (human myeloid progenitor cells)

Treatment:

Biological: human myeloid progenitor cells

Drug: G-CSF

Induction Group B1 (cytarabine HIDAC)

Active Comparator group

Description:

G-CSF

Treatment:

Drug: G-CSF

Induction Group B2 (cytarabine HIDAC)

Experimental group

Description:

Intermediate dose CLT-008 (human myeloid progenitor cells)

Treatment:

Biological: human myeloid progenitor cells

Drug: G-CSF

Induction Group B3 (cytarabine HIDAC)

Experimental group

Description:

High dose CLT-008 (human myeloid progenitor cells)

Treatment:

Biological: human myeloid progenitor cells

Drug: G-CSF