NCT01820624

Lithium Carbonate and Tretinoin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed Phase 1 Last updated 27 April 2017

What this trial tests

Phase 1 trial testing tretinoin in Adult Acute Megakaryoblastic Leukemia (M7) in 12 participants. Completed in 13 November 2015.

Timeline

30 April 2013

Primary endpoint
9 October 2015

13 November 2015

Quick facts

Lead sponsor	Paolo Caimi, MD
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	30 April 2013
Primary completion	9 October 2015
Estimated completion	13 November 2015
Sites	1 location across United States

Drugs / interventions tested

• tretinoin (TRETINOIN) — full drug profile →
• lithium carbonate (lithium carbonate) — full drug profile →
• laboratory biomarker analysis — 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

Paolo Caimi, MD

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 phase I trial studies the side effects and best dose of tretinoin when given together with lithium carbonate in treating patients with relapsed or refractory acute myeloid leukemia. Lithium carbonate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Tretinoin may help \[type of cancer\] cells become more like normal cells, and to grow and spread more slowly. Giving lithium carbonate together with tretinoin may kill more cancer cells

Publications & conference data

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

1. Glycogen synthesis and beyond, a comprehensive review of GSK3 as a key regulator of metabolic pathways and a therapeutic target for treating metabolic diseases.
   Wang L, Li J, Di LJ, Di LJ. · · 2022 · cited 148× · PMID 34729791 · DOI 10.1002/med.21867
2. An ATRActive future for differentiation therapy in AML.
   Johnson DE, Redner RL. · · 2015 · cited 45× · PMID 25631637 · DOI 10.1016/j.blre.2015.01.002
3. GSK-3 Inhibition Sensitizes Acute Myeloid Leukemia Cells to 1,25D-Mediated Differentiation.
   Gupta K, Stefan T, Ignatz-Hoover J, Moreton S, et al · · 2016 · cited 35× · PMID 26964622 · DOI 10.1158/0008-5472.can-15-2290
4. Therapeutic Modulation of Autophagy in Leukaemia and Lymphoma.
   Djavaheri-Mergny M, Giuriato S, Tschan MP, Humbert M. · · 2019 · cited 34× · PMID 30704144 · DOI 10.3390/cells8020103
5. Lithium: A Promising Anticancer Agent.
   Villegas-Vázquez EY, Quintas-Granados LI, Cortés H, González-Del Carmen M, et al · · 2023 · cited 19× · PMID 36836894 · DOI 10.3390/life13020537
6. Phase I Trial of Lithium and Tretinoin for Treatment of Relapsed and Refractory Non-promyelocytic Acute Myeloid Leukemia.
   Ueda M, Stefan T, Stetson L, Ignatz-Hoover JJ, et al · · 2020 · cited 10× · PMID 32211336 · DOI 10.3389/fonc.2020.00327
7. Novel Insights into the Role of Kras in Myeloid Differentiation: Engaging with Wnt/β-Catenin Signaling.
   Yokoyama N, Nakayama H, Iwabuchi K. · · 2023 · cited 4× · PMID 36672256 · DOI 10.3390/cells12020322