Who is sponsoring NCT01297543?

NCT01297543 is sponsored by Cellerant Therapeutics.

What drugs are being tested in NCT01297543?

Interventions in NCT01297543: human myeloid progenitor cells, G-CSF.

What condition does NCT01297543 study?

NCT01297543 studies Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Myelodysplasia.

Is NCT01297543 still recruiting?

NCT01297543 is currently completed. Last updated 29 June 2016.

Last reviewed 2016-06-29 · How we verify

NCT01297543

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1/Phase 2 Last updated 29 June 2016

What this trial tests

Phase 1/Phase 2 trial testing human myeloid progenitor cells in Acute Myeloid Leukemia in 45 participants. Completed in 1 January 2015.

Timeline

1 March 2011

Primary endpoint
1 November 2014

1 January 2015

Quick facts

Lead sponsor	Cellerant Therapeutics
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	45
Start date	1 March 2011
Primary completion	1 November 2014
Estimated completion	1 January 2015
Sites	10 locations across United States

Drugs / interventions tested

human myeloid progenitor cells — full drug profile →
G-CSF (g-csf) — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
Chronic Myeloid Leukemia — all drugs for Chronic Myeloid Leukemia →
Myelodysplasia — all drugs for Myelodysplasia →

Sponsor

Cellerant Therapeutics — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Incidence of serious adverse reactions
Time frame: Consolidation patients-43 days post dose and Induction/re-induction patients-40 days post dose

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Neutrophils Derived from Genetically Modified Human Induced Pluripotent Stem Cells Circulate and Phagocytose Bacteria In Vivo.
Trump LR, Nayak RC, Singh AK, Emberesh S, et al · · 2019 · cited 39× · PMID 30793529 · DOI 10.1002/sctm.18-0255
In Vitro Human Haematopoietic Stem Cell Expansion and Differentiation.
Bozhilov YK, Hsu I, Brown EJ, Wilkinson AC. · · 2023 · cited 38× · PMID 36980237 · DOI 10.3390/cells12060896
Alternative blood products and clinical needs in transfusion medicine.
Whitsett C, Vaglio S, Grazzini G. · · 2012 · cited 6× · PMID 22567025 · DOI 10.1155/2012/639561

Verify or expand the search:

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

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NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01297543 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cellerant Therapeutics
Last refreshed: 29 June 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01297543.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing