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

C

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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