Clinical trial · Interventional
Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
A Phase II Randomized Trial of Immunologic and Chemotherapeutic Agents for Treatment of Patients With Relapsed or Refractory Acute Myelogenous Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining more than one drug or combining monoclonal antibody with chemotherapy may kill more cancer cells. It is not yet known which treatment regimen is more effective for acute myelogenous leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of three treatment regimens in treating patients who have relapsed or refractory acute myelogenous leukemia.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
| liposomal daunorubicin citrate | Drug | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven acute myelogenous leukemia of one of the following types:
* Acute myeloblastic leukemia (FAB type M0, M1, or M2)
* Acute promyelocytic leukemia (FAB type M3) allowed if ineligible for an ECOG M3 protocol or if no tretinoin or arsenic trioxide therapy is planned
* Acute myelomonocytic leukemia (FAB type M4)
* Acute monocytic leukemia (FAB type M5)
* Acute erythroleukemia (FAB type M6)
* Acute megakaryocytic leukemia (FAB type M7)
* Must meet 1 of the following criteria:
* Relapse less than 6 months after first complete remission (CR)
* Relapse 6-12 months after first CR
* Refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course)
* Must have marrow documentation of residual leukemia after chemotherapy (for at least 2 weeks duration)
* Second or greater relapse
* No relapse greater than 1 year after achieving first CR
* Blast cells must be CD33 positive
* Prior CNS leukemia allowed if there is currently documentation of no CNS involvement on CSF examination (i.e., negative CSF by lumbar puncture)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin no greater than 2.0 mg/dL\*
* SGOT less than 2 times upper limit of normal\* NOTE: \*Unless due to leukemia infiltration
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* See Chemotherapy
* No myocardial infarction within the past 3 months
* No significant congestive heart failure
* No significant cardiac arrhythmia
* Cardiac ejection fraction normal by MUGA scan or echocardiogram
* Resting ejection fraction at least 50% or at least 5% increase with exercise
* Shortening fraction at least 24% or normal by echocardiogram
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No concurrent organ damage or other medical problems that would precludestudy therapy
* No concurrent evidence (including positive blood or deep tissue cultures or stains) of invasive fungal infection
* No hypersensitivity to ingredients of gemtuzumab ozogamicin or daunorubicin liposomal
* No other active tumor that would interfere with study therapy or increase risk
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior gemtuzumab ozogamicin
Chemotherapy:
* See Disease Characteristics
* See Biologic therapy
* No prior daunorubicin liposomal or topotecan
* Prior doxorubicin (no greater than 300 mg/m2), daunorubicin (no greater than 300 mg/m2), idarubicin (no greater than 100 mg/m2), or mitoxantrone (no greater than 100 mg/m2) allowed if left ventricular function is adequate
* At least 4 weeks since prior chemotherapy except patients who are refractory to conventional initial induction chemotherapy
* Prior hydroxyurea allowed within 4 weeks prior to beginning study
* Hydroxyurea must be discontinued at least 24 hours prior to beginning study
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 4 weeks since prior radiotherapy except patients who are refractory to conventional initial induction chemotherapy
Surgery:
* Not specifiedReferences
Publications (2)
- RESULTLitzow MR, Othus M, Cripe LD, Gore SD, Lazarus HM, Lee SJ, Bennett JM, Paietta EM, Dewald GW, Rowe JM, Tallman MS; Eastern Cooperative Oncology Group Leukemia Committee. Failure of three novel regimens to improve outcome for patients with relapsed or refractory acute myeloid leukaemia: a report from the Eastern Cooperative Oncology Group. Br J Haematol. 2010 Jan;148(2):217-25. doi: 10.1111/j.1365-2141.2009.07917.x. Epub 2009 Oct 5. PMID 19804455
- RESULTLitzow MR, Goloubeva O, Rowe J, et al.: A randomized phase II trial of gemtuzumab ozogamicin vs. liposomal daunorubicin vs. cyclophosphamide plus topotecan, each combined with intermediate dose Ara-C for the treatment of patients with relapsed or refractory acute myelogenous leukemia . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2359, 2003.