Phase IB/II of CPX-351 as Maintenance Therapy in AML Patients Ineligible for Bone Marrow Transplantation

Who is this study for? Patients with acute myeloid leukemia ineligible for bone marrow transplantation
What treatments are being studied? CPX-351
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a phase IB/II study with a 3+3 dose de-escalation study design. Patients will continue maintenance treatment with CPX-351 for 6 cycles on D1 and D3, as long as patient remains in CR. The dose de-escalation will be one dose given on D1 only, every 28 days pending toxicity. The maximum tolerated dose will be used for the phase II expansion portion of the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Newly diagnosed patients \> 18 years of age

• Patients must be in CR or CRh (complete remission with partial count recovery).

• Must have received ANY induction treatment with standard consolidation or hypomethylating agent (HMA) + venetoclax, for up to 6 cycles or no more than one year of treatment.

• Must be able to start therapy within 3 months of last documented CR

• De novo or secondary AML/treatment related AML (non-M3) including AML with myelodysplasia-related changes (MRC), histologically confirmed

• Patients must be ineligible for allogeneic BMT (for any reason including poor performance status, patient's preference, favorable AML not a candidate for transplant, or comorbidities and age precluding from transplant etc)

• Cardiac ejection fraction ≥ 50% by transthoracic echocardiography or MUGA scan

• Adequate hepatic and renal function defined as:

‣ Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN)

⁃ Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3 is permissible if due to disease.

⁃ Bilirubin ≤3 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)

⁃ Estimated Creatinine Clearance ≥30 ml/min (Cockcroft-Gault based on actual weight) (See Appendix A)

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3 (Appendix A)

• Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry.

• Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices \[IUDs\], sexual abstinence, or sterilized partner) during the period of therapy and for at least 6 months after the last dose of study drug

Locations
United States
Washington, D.c.
Georgetown Lombardi Comprehensive Cancer Center
RECRUITING
Washington D.c.
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING
Hackensack
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Time Frame
Start Date: 2023-05-22
Estimated Completion Date: 2025-12
Participants
Target number of participants: 24
Treatments
Experimental: CPX-351
Dose Level 1: CPX-351 administered through intravenou infusion on Day 1 and Day 3 of 28 day cycle for 6 cycles or Dose Level -1: CPX-351 administered through intravenous infusion on Day 1 of each 28 day cycle for 6 cycles.
Authors
Catherine Lai
Sponsors
Collaborators: Jazz Pharmaceuticals, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Georgetown University

This content was sourced from clinicaltrials.gov

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