Acute Myeloid LeukemiaPhase 1/2NCT01297543
Safety Study of Human Myeloid Progenitor Cells (CLT-008) After Chemotherapy for Leukemia
A Phase 1/2 study testing human myeloid progenitor cells and G-CSF in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Cellerant Therapeutics at 10 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia
- What is being tested?
- human myeloid progenitor cells and G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2011to Jan 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hematological malignancy, including:
- AML, ALL or MDS
- Planned treatment with cytarabine-based chemotherapy regimen
- Adequate hepatic, renal, hematologic, cardiac and respiratory function
Who cannot join
- Prior allograft or history of active GVHD within 3 years
- Pregnant or nursing
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Indiana Blood and Marrow Transplantation, LLC
Beech Grove, Indiana, 46107
Cleveland Clinic
Cleveland, Ohio, 44195
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Moores UCSD Cancer Center
La Jolla, California, 92037
Loyola University Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, 60153
University of Minnesota
Minneapolis, Minnesota, 55455
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
University of California San Francisco Medical Center
San Francisco, California, 94143
Stanford Hospital and Clinics
Stanford, California, 94305
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia
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.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Myelodysplasia
- Being tested
- human myeloid progenitor cells, G-CSF
- Keywords
- Induction chemotherapy, Re-induction chemotherapy, Consolidation chemotherapy, Leukemia, Myelodysplasia
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Anemia, Refractory, with Excess of Blasts, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human myeloid progenitor cellsBiological
Also called CLT-008, hMPC
Single intravenous injection/infusion
G-CSFDrug
Also called filgrastim, granulocyte colony stimulating factor
Background therapy
| Study group | Role | What they receive |
|---|---|---|
| Consolidation Group A | Experimental | Low dose CLT-008 (human myeloid progenitor cells) Receives: Biological: human myeloid progenitor cells; Drug: G-CSF |
| Consolidation Group B | Experimental | Intermediate dose CLT-008 (human myeloid progenitor cells) Receives: Biological: human myeloid progenitor cells; Drug: G-CSF |
| Consolidation Group C | Experimental | Intermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF Receives: Biological: human myeloid progenitor cells |
| Consolidation Group D | Experimental | High dose CLT-008 (human myeloid progenitor cells) Receives: Biological: human myeloid progenitor cells; Drug: G-CSF |
| Induction Group A1 (cytarabine 7+3) | Active comparator | G-CSF Receives: Drug: G-CSF |
| Induction Group A2 (cytarabine 7+3) | Experimental | Intermediate dose CLT-008 (human myeloid progenitor cells) Receives: Biological: human myeloid progenitor cells; Drug: G-CSF |
| Induction Group A3 (cytarabine 7+3) | Experimental | High dose CLT-008 (human myeloid progenitor cells) Receives: Biological: human myeloid progenitor cells; Drug: G-CSF |
| Induction Group B1 (cytarabine HIDAC) | Active comparator | G-CSF Receives: Drug: G-CSF |
| Induction Group B2 (cytarabine HIDAC) | Experimental | Intermediate dose CLT-008 (human myeloid progenitor cells) Receives: Biological: human myeloid progenitor cells; Drug: G-CSF |
| Induction Group B3 (cytarabine HIDAC) | Experimental | High dose CLT-008 (human myeloid progenitor cells) Receives: Biological: human myeloid progenitor cells; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse reactions
Measured: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Secondary outcomes (10)
Duration of neutropenia
Measured: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of thrombocytopenia
Measured: 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
Measured: 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
Measured: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of mucositis
Measured: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of infections
Measured: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of fever
Measured: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of antibiotic use
Measured: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of hospitalization
Measured: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of hospitalization
Measured: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellerant Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297543
- Sponsor's protocol ID
- CLT008-02
- Status last verified
- Jun 2016
- First submitted
- 11 Feb 2011
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of CLT-008 Myeloid Progenitor Cells in Patients Receiving Chemotherapy for Leukemia or Myelodysplasia
- ClinicalTrials.gov ID
- NCT01297543
- Acronym / sponsor ID
- CLT008-02
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Myelodysplasia
- Keywords
- Induction chemotherapy, Re-induction chemotherapy, Consolidation chemotherapy, Leukemia, Myelodysplasia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cellerant TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- Mar 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Consolidation Group A | Experimental | Biological: human myeloid progenitor cells, Drug: G-CSFLow dose CLT-008 (human myeloid progenitor cells) |
| Consolidation Group B | Experimental | Biological: human myeloid progenitor cells, Drug: G-CSFIntermediate dose CLT-008 (human myeloid progenitor cells) |
| Consolidation Group C | Experimental | Biological: human myeloid progenitor cellsIntermediate dose CLT-008 (human myeloid progenitor cells), no G-CSF |
| Consolidation Group D | Experimental | Biological: human myeloid progenitor cells, Drug: G-CSFHigh dose CLT-008 (human myeloid progenitor cells) |
| Induction Group A1 (cytarabine 7+3) | Active comparator | Drug: G-CSFG-CSF |
| Induction Group A2 (cytarabine 7+3) | Experimental | Biological: human myeloid progenitor cells, Drug: G-CSFIntermediate dose CLT-008 (human myeloid progenitor cells) |
| Induction Group A3 (cytarabine 7+3) | Experimental | Biological: human myeloid progenitor cells, Drug: G-CSFHigh dose CLT-008 (human myeloid progenitor cells) |
| Induction Group B1 (cytarabine HIDAC) | Active comparator | Drug: G-CSFG-CSF |
| Induction Group B2 (cytarabine HIDAC) | Experimental | Biological: human myeloid progenitor cells, Drug: G-CSFIntermediate dose CLT-008 (human myeloid progenitor cells) |
| Induction Group B3 (cytarabine HIDAC) | Experimental | Biological: human myeloid progenitor cells, Drug: G-CSFHigh dose CLT-008 (human myeloid progenitor cells) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hematological malignancy, including:
- Planned treatment with cytarabine-based chemotherapy regimen
- Adequate hepatic, renal, hematologic, cardiac and respiratory function
Key exclusion criteria (2 listed)
- Prior allograft or history of active GVHD within 3 years
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human myeloid progenitor cellsAlso: CLT-008, hMPCSingle intravenous injection/infusion | Biological | Consolidation Group A, Consolidation Group B, Consolidation Group C, Consolidation Group D, Induction Group A2 (cytarabine 7+3), Induction Group A3 (cytarabine 7+3), Induction Group B2 (cytarabine HIDAC), Induction Group B3 (cytarabine HIDAC) |
| G-CSFAlso: filgrastim, granulocyte colony stimulating factorBackground therapy | Drug | Consolidation Group A, Consolidation Group B, Consolidation Group D, Induction Group A1 (cytarabine 7+3), Induction Group A2 (cytarabine 7+3), Induction Group A3 (cytarabine 7+3), Induction Group B1 (cytarabine HIDAC), Induction Group B2 (cytarabine HIDAC), Induction Group B3 (cytarabine HIDAC) |
Primary outcome
Incidence of serious adverse reactions
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
10 secondary outcomes
Duration of neutropenia
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of thrombocytopenia
Time frame: 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
Time frame: 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
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of mucositis
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of infections
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of fever
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of antibiotic use
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Incidence of hospitalization
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Duration of hospitalization
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Cellerant Therapeutics, Inc.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing human myeloid progenitor cells and G-CSF in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Cellerant Therapeutics at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse reactions (time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.