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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Biological: human myeloid progenitor cells
* Drug: G-CSF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Consolidation Group A<br>Low dose CLT-008 (human myeloid progenitor cells) | Biological: human myeloid progenitor cells<br>* Single intravenous injection/infusion<br>* Other names: hMPC;Drug: G-CSF<br>* Background therapy<br>* Other names: granulocyte colony stimulating factor;|
| Experimental: Consolidation Group B<br>Intermediate dose CLT-008 (human myeloid progenitor cells) | Biological: human myeloid progenitor cells<br>* Single intravenous injection/infusion<br>* Other names: hMPC;Drug: G-CSF<br>* Background therapy<br>* Other names: granulocyte colony stimulating factor;|
| Experimental: Consolidation Group C<br>Intermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF | Biological: human myeloid progenitor cells<br>* Single intravenous injection/infusion<br>* Other names: hMPC;|
| Experimental: Consolidation Group D<br>High dose CLT-008 (human myeloid progenitor cells) | Biological: human myeloid progenitor cells<br>* Single intravenous injection/infusion<br>* Other names: hMPC;Drug: G-CSF<br>* Background therapy<br>* Other names: granulocyte colony stimulating factor;|
| Active Comparator: Induction Group A1 (cytarabine 7+3)<br>G-CSF | Drug: G-CSF<br>* Background therapy<br>* Other names: granulocyte colony stimulating factor;|
| Experimental: Induction Group A2 (cytarabine 7+3)<br>Intermediate dose CLT-008 (human myeloid progenitor cells) | Biological: human myeloid progenitor cells<br>* Single intravenous injection/infusion<br>* Other names: hMPC;Drug: G-CSF<br>* Background therapy<br>* Other names: granulocyte colony stimulating factor;|
| Experimental: Induction Group A3 (cytarabine 7+3)<br>High dose CLT-008 (human myeloid progenitor cells) | Biological: human myeloid progenitor cells<br>* Single intravenous injection/infusion<br>* Other names: hMPC;Drug: G-CSF<br>* Background therapy<br>* Other names: granulocyte colony stimulating factor;|
| Active Comparator: Induction Group B1 (cytarabine HIDAC)<br>G-CSF | Drug: G-CSF<br>* Background therapy<br>* Other names: granulocyte colony stimulating factor;|
| Experimental: Induction Group B2 (cytarabine HIDAC)<br>Intermediate dose CLT-008 (human myeloid progenitor cells) | Biological: human myeloid progenitor cells<br>* Single intravenous injection/infusion<br>* Other names: hMPC;Drug: G-CSF<br>* Background therapy<br>* Other names: granulocyte colony stimulating factor;|
| Experimental: Induction Group B3 (cytarabine HIDAC)<br>High dose CLT-008 (human myeloid progenitor cells) | Biological: human myeloid progenitor cells<br>* Single intravenous injection/infusion<br>* Other names: hMPC;Drug: G-CSF<br>* Background therapy<br>* Other names: granulocyte colony stimulating factor;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induction chemotherapy, Re-induction chemotherapy, Consolidation chemotherapy, Leukemia, Myelodysplasia