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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consolidation Group A | Experimental | Low dose CLT-008 (human myeloid progenitor cells) |
|
| Consolidation Group B | Experimental | Intermediate dose CLT-008 (human myeloid progenitor cells) |
|
| Consolidation Group C | Experimental | Intermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF |
|
| Consolidation Group D | Experimental | High dose CLT-008 (human myeloid progenitor cells) |
|
| Induction Group A1 (cytarabine 7+3) | Active Comparator | G-CSF |
|
| Induction Group A2 (cytarabine 7+3) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human myeloid progenitor cells | Biological | Single intravenous injection/infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious adverse reactions | Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of neutropenia | Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose | |
| Duration of thrombocytopenia | Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose |
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Key Inclusion Criteria:
Hematological malignancy, including:
Planned treatment with cytarabine-based chemotherapy regimen
Adequate hepatic, renal, hematologic, cardiac and respiratory function
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores UCSD Cancer Center | La Jolla | California | 92037 | United States | ||
| University of California San Francisco Medical Center |
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| Label | URL |
|---|---|
| Cellerant Therapeutics, Inc. | View source |
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Intermediate dose CLT-008 (human myeloid progenitor cells) |
|
| Induction Group A3 (cytarabine 7+3) | Experimental | High dose CLT-008 (human myeloid progenitor cells) |
|
| Induction Group B1 (cytarabine HIDAC) | Active Comparator | G-CSF |
|
| Induction Group B2 (cytarabine HIDAC) | Experimental | Intermediate dose CLT-008 (human myeloid progenitor cells) |
|
| Induction Group B3 (cytarabine HIDAC) | Experimental | High dose CLT-008 (human myeloid progenitor cells) |
|
|
| G-CSF | Drug | Background therapy |
|
|
| 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 |
| Incidence of infections | 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 |
| San Francisco |
| California |
| 94143 |
| United States |
| Stanford Hospital and Clinics | Stanford | California | 94305 | United States |
| Loyola University Medical Center, Cardinal Bernardin Cancer Center | Maywood | Illinois | 60153 | United States |
| Indiana Blood and Marrow Transplantation, LLC | Beech Grove | Indiana | 46107 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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