Clinical trial · Interventional
Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia
A Phase II Study of Gemcitabine/ Mitoxantrone in Patients With Acute Myeloid Leukemia in First Relapse
NCT00268242CI-TRIAL-00031764terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): If \</= 5 of the initial 18 patients had a CR, the study would be stopped. Only 5 patients (21%) of 24 enrolled patients had a CR so the study was terminated.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with mitoxantrone works in treating patients with relapsed acute myeloid 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
| Mitoxantrone Hydrochloride | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Mitoxantrone
- description
- Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m\^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m\^2/day I.V. on days 1, 2, and 3.
- interventionNames
- Drug: Gemcitabine Hydrochloride
- Drug: Mitoxantrone Hydrochloride
Primary outcomes (2)
- measure
- Complete Response Rate
- timeFrame
- 4 Weeks
- description
- Assumptions/ hypothesis: A Complete Response (CR) rate of 30% or less is unacceptable, and 50% or more is promising. A two-stage design will be used. Initially, 18 patients will be enrolled. If 5 or fewer achieve CR, the study will be stopped. Otherwise, an additional 22 patients will be accrued. Accrual was not halted while follow-up of the first 18 evaluable patients was under way. Therefore, 24 patients were enrolled. Four weeks is anticipated for observation for response. Only 5 patients (21%) achieved a CR and therefore, the study was terminated. Since response was assessed using the International Working Group criteria, a complete response was determined by Morphologic complete remission: A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of ≥ 100,000/μL, a cytogenic CR and a morphologic CR with incomplete blood count recovery (CRi).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Bone marrow examination or peripheral blood analysis confirming active acute myeloid leukemia by WHO criteria * No M3 acute myeloid leukemia * Not a candidate for allogenic bone marrow transplantation * Patient must be in first relapse after having received induction chemotherapy * Received 1 or 2 courses with remission lasting at least 1 month * Patients with chloromas or leukemia cutis are eligible * No evidence of leptomeningeal involvement PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Liver enzymes (total bilirubin, aspartate aminotransferase (AST) and ALT) ≤ 2.5 times the upper limits of normal * Liver enzymes ≥ 2.5 are acceptable if physician documents that it is secondary to the disease * Serum creatinine ≤ 3 mg/dL * No poorly controlled medical conditions that would seriously complicate compliance with this study * No other active primary malignancy other than carcinoma in situ of the cervix or basal cell carcinoma of the skin * No New York Heart Association grade III or IV cardiac problems, defined as congestive heart failure or myocardial infarction within 6 months prior to start of study * Pregnant or nursing women are ineligible * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No documented history of human immunodeficiency virus (HIV) infection * No history of chronic liver disease * Ejection fraction ≥ 45% * No significant history of non-compliance to medical regimens or inability to give reliable informed consent PRIOR CONCURRENT THERAPY: * Previous treatment related toxicities should be resolved to grade 1 or better * No other investigational agents within 14 days prior to the start of study * No chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to start of study * No major surgery within 2 weeks prior to start of study * At least two weeks must have elapsed since the conclusion of radiation therapy and the start of gemcitabine hydrochloride, provided the acute effects of radiation treatment have been resolved
References
Publications (0)
Data not yet available
No reference posted for this study.