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NCT Number: NCT01297543

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Chronic Disease Chronic Myeloid Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Myelodysplasia Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Moores UCSD Cancer Center, La Jolla, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human myeloid progenitor cells

Biological

Single intravenous injection/infusion

Other names: CLT-008, hMPC

G-CSF

Drug

Background therapy

Other names: filgrastim, granulocyte colony stimulating factor

Primary outcomes

  1. Incidence of serious adverse reactions

    Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

Secondary outcomes

  1. Duration of neutropenia

    Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

  2. Duration of thrombocytopenia

    Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

  3. Duration of presence of CLT-008 derived cells in blood

    Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

  4. Duration of presence of CLT-008 derived cells in bone marrow

    Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

  5. Incidence of mucositis

    Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

  6. Incidence of infections

    Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

  7. Duration of fever

    Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

  8. Duration of antibiotic use

    Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

  9. Incidence of hospitalization

    Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

  10. Duration of hospitalization

    Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

Sponsors and collaborators

Lead sponsor

Cellerant Therapeutics

Industry

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Feb 16, 2011
Registry last updated
Jul 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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