Clinical trial · Interventional
CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia
A Phase Ib Trial With Dose Expansion Evaluating CPX-351 Plus Gemtuzumab Ozogamicin for Relapsed Acute Myelogenous Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
This phase Ib trial studies the best dose of gemtuzumab ozogamicin when given together with CPX-351 in treating patients with acute myeloid leukemia that has come back after it was previously in remission. CPX-351 is a chemotherapy, which works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to chemotherapy called calicheamicin. Gemtuzumab attaches to CD33 (transmembrane receptor) positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving CPX-351 and gemtuzumab ozogamicin may work better in treating patients with acute myeloid leukemia, compared to giving only one of these therapies alone.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemtuzumab Ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
| Liposome-encapsulated Daunorubicin-Cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (CPX-351, gemtuzumab ozogamicin)
- description
- INDUCTION: Patients receive liposome-encapsulated daunorubicin 44mg/m2 - cytarabine 100mg/m2 IV over 90 minutes on days 1, 3, and 5, and gemtuzumab ozogamicin 3 mg/m2 (max 4.5 mg) IV over 120 minutes on day 7, or days 4 and 7, or days 1, 4, and 7 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive consolidation therapy at the discretion of the treating physician and/or proceed to allogeneic HSCT.
- interventionNames
- Drug: Gemtuzumab Ozogamicin
- Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Up to day 42
- description
- MTD is defined as the cohort of participants one cohort below the cohort that develop dose-limiting toxicity (DLT) in at least 2 participants.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Bone marrow blasts \>= 5% that develops after remission, no restriction on prior number of relapses or regimens * Eastern Cooperative Oncology Group (ECOG) 0-2 * At least a 3-month duration of remission prior to relapse * Participants with relapse after allogeneic transplantation are included * Up to 1 cycle of hypomethylating agent monotherapy at time of relapse is allowed, must be discontinued at least 14 days prior to start of salvage induction * Serum total bilirubin =\< 2.0 mg/dL, unless considered due to Gilbert?s disease or leukemia involvement * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 times the upper limit of normal, unless considered due to leukemia involvement * Alkaline phosphatase =\< 3 times the upper limit of normal, unless considered due to leukemia involvement * Serum creatinine =\< 2.0 mg/dL, or creatinine clearance \> 40 mL/min based on Cockcroft-Gault glomerular filtration rate (GFR) * Ability to give full informed consent on their own * Females of reproductive potential (postmenopausal for less than 24 consecutive months) must have a negative pregnancy Exclusion Criteria: * Currently receiving targeted therapy for FLT3 (cytokine receptor tyrosine kinase class III), IDH1, or IDH2 (isocitrate dehydrogenase, 1, 2) mutations and intent to continue use; prior use of targeted therapy for such mutations is allowed, but agents should be discontinued 1 week prior to enrollment * Acute promyelocytic leukemia * Second malignancy that would limit survival by less than 2 years * New York Heart Association class III or VI * Left ventricular ejection fraction \< 50% * History of coronary stent placement that requires mandatory continuation of dual-antiplatelet therapy * History of Wilson?s disease or other copper handling disorders * Hypersensitivity to cytarabine, daunorubicin, or liposomal products * Active invasive fungal infection * Active bacterial or viral infection manifesting as fevers or hemodynamic instability within the past 72 hours * Lifetime cumulative daunorubicin-equivalent anthracycline dose \> 368 mg/m\^2
References
Publications (1)
- DERIVEDJentzsch M, Grimm J, Bill M, Brauer D, Backhaus D, Goldmann K, Schulz J, Niederwieser D, Platzbecker U, Schwind S. ELN risk stratification and outcomes in secondary and therapy-related AML patients consolidated with allogeneic stem cell transplantation. Bone Marrow Transplant. 2021 Apr;56(4):936-945. doi: 10.1038/s41409-020-01129-1. Epub 2020 Nov 19. PMID 33208914