NCT01822015 is a EARLY_PHASE1 clinical trial of Sirolimus in Adult Acute Megakaryoblastic Leukemia (M7), sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

What drugs are being tested in NCT01822015?

Interventions in NCT01822015: Sirolimus, Idarubicin, Cytarabine.

What condition does NCT01822015 study?

NCT01822015 studies Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Untreated Adult Acute Myeloid Leukemia.

Is NCT01822015 still recruiting?

NCT01822015 is currently completed. Last updated 29 April 2025.

Last reviewed 2025-04-29 · How we verify

NCT01822015

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

Sirolimus, Idarubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed EARLY_PHASE1 Last updated 29 April 2025

What this trial tests

EARLY_PHASE1 trial testing Sirolimus in Adult Acute Megakaryoblastic Leukemia (M7) in 55 participants. Completed in 12 December 2019.

Timeline

15 March 2013

Primary endpoint
12 December 2019

12 December 2019

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	15 March 2013
Primary completion	12 December 2019
Estimated completion	12 December 2019
Sites	1 location across United States

Drugs / interventions tested

Sirolimus (sirolimus) — full drug profile →
Idarubicin (IDARUBICIN) — full drug profile →
Cytarabine — full drug profile →

Conditions studied

Adult Acute Megakaryoblastic Leukemia (M7) — all drugs for Adult Acute Megakaryoblastic Leukemia (M7) →
Adult Acute Monoblastic Leukemia (M5a) — all drugs for Adult Acute Monoblastic Leukemia (M5a) →
Adult Acute Monocytic Leukemia (M5b) — all drugs for Adult Acute Monocytic Leukemia (M5b) →
Adult Acute Myeloblastic Leukemia With Maturation (M2) — all drugs for Adult Acute Myeloblastic Leukemia With Maturation (M2) →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Who can join

18 and older, any sex, with Adult Acute Megakaryoblastic Leukemia (M7) or Adult Acute Monoblastic Leukemia (M5a). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot clinical trial studies sirolimus, idarubicin, and cytarabine in treating patients with newly diagnosed acute myeloid leukemia. Sirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sirolimus together with idarubicin and cytarabine may kill more cancer cells.

Publications & conference data

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

Targeting PI3K/Akt/mTOR in AML: Rationale and Clinical Evidence.
Darici S, Alkhaldi H, Horne G, Jørgensen HG, et al · · 2020 · cited 87× · PMID 32932888 · DOI 10.3390/jcm9092934
Molecular therapeutic approaches for pediatric acute myeloid leukemia.
Tasian SK, Pollard JA, Aplenc R. · · 2014 · cited 29× · PMID 24672775 · DOI 10.3389/fonc.2014.00055
Update on acute myeloid leukemia stem cells: New discoveries and therapeutic opportunities.
Stahl M, Kim TK, Zeidan AM. · · 2016 · cited 15× · PMID 27822339 · DOI 10.4252/wjsc.v8.i10.316
Acute Myeloid Leukemia: Advancements in Diagnosis and Treatment.
Yu MG, Zheng HY. · · 2017 · cited 8× · PMID 28091414 · DOI 10.4103/0366-6999.198004
A Phase I Trial of Sirolimus with "7&3" Induction Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia.
Palmisiano N, Jeschke G, Wilde L, Alpdogan O, et al · · 2023 · cited 1× · PMID 37958304 · DOI 10.3390/cancers15215129
Exploring the Bone Marrow Microenvironment as a Therapeutic Barrier and Targetable Source of Crosstalk in Acute Myeloid Leukemia
Kolosova A, Mould I, Pepper C, Mitchell S, et al · · 2026
Implementation of Natural Products and Derivatives in Acute Myeloid Leukemia Management: Current Treatments, Clinical Trials and Future Directions.
Merhi F, Dauzonne D, Bauvois B. · · 2026 · PMID 41595108 · DOI 10.3390/cancers18020185

Verify or expand the search:

Other trials of Sirolimus

Trials testing the same drug.

NCT07542314 — Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a · Phase 4 · not yet recruiting
NCT06876142 — Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma · Phase 1, PHASE2 · suspended
NCT07052929 — Study of ASP2957 in Male Participants With X-linked Myotubular Myopathy Who Need Ventilators · Phase 1, PHASE2 · recruiting
NCT04370795 — Matched Related and Unrelated Donor Stem Cell Transplantation for Severe Combined Immune Deficiency (SCID): Busulfan-bas · Phase 1, PHASE2 · withdrawn
NCT07162038 — Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA- · Phase 1 · recruiting

Other Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University trials

Trials by the same sponsor.

NCT06974981 — Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry · recruiting
NCT03796884 — Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer · Phase 2 · active not recruiting
NCT03712904 — Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma · Phase 2 · terminated
NCT03807492 — Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR) · completed
NCT03477864 — Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progres · Phase 1 · withdrawn

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 NCT01822015 (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 Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Last refreshed: 29 April 2025

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/NCT01822015.

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