Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00268242|
Recruitment Status : Terminated (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.)
First Posted : December 22, 2005
Results First Posted : October 5, 2015
Last Update Posted : February 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Gemcitabine Hydrochloride Drug: Mitoxantrone Hydrochloride||Phase 2|
- Determine the complete response (CR) rate (CR and incomplete blood count recovery (CRi)) of patients with acute myeloid leukemia in first relapse treated with gemcitabine hydrochloride and mitoxantrone hydrochloride.
- Evaluate disease free and overall survival of patients with acute myeloid leukemia in first relapse treated with this particular chemotherapy regimen.
- Assess hematologic and non-hematologic toxicity associated with this regimen.
- Assess laboratory correlates of drug resistance in patients with relapsed acute myeloid leukemia.
- Assess the percentage of patients receiving subsequent bone marrow transplantation.
OUTLINE: This is an open-label, multicenter study.
Patients receive gemcitabine hydrochloride IV over 12 hours on day 1 and mitoxantrone hydrochloride IV over 30-60 minutes on days 1, 2, and 3. After completion of a single course of therapy, patients who achieve a complete response may receive 1 additional course of therapy at the discretion of the treating physician.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Gemcitabine/ Mitoxantrone in Patients With Acute Myeloid Leukemia in First Relapse|
|Study Start Date :||January 2006|
|Primary Completion Date :||August 2010|
|Study Completion Date :||July 2011|
Experimental: Gemcitabine + Mitoxantrone
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.
Drug: Gemcitabine Hydrochloride
10 mg/m2/ min IV for 12 hours
Other Name: GemcitabineDrug: Mitoxantrone Hydrochloride
12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3
Other Name: Mitoxantrone
- Complete Response Rate [ Time Frame: 4 Weeks ]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).
- Duration of the First Complete Response [ Time Frame: After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years. ]
- Disease-free and Overall Survival [ Time Frame: After a CR is achieved, patients are followed at 3 month intervals for disease progression and survival. If a patient has disease progression after achieving a CR, survival will be captured at 6 month intervals, typically for up to 5 years. ]
- Laboratory Correlates: Immunohistochemistry [ Time Frame: Baseline ]
Percentage of patients who had a moderate-strong (2-3+) expression of multidrug resistance (MDR) genes by immunohistochemistry.
- Multidrug resistance gene 1 (MDR1)
- Equilibrative nucleoside transporter 2(SLC29A2)
- White Blood Cell Count at Time of Relapse [ Time Frame: After a CR is achieved, patient will be followed at 3 month intervals for disease progression, typically for up to 5 years. ]
- Percentage of Patients Making it to Bone Marrow Transplant. [ Time Frame: After completion of protocol therapy ]Assessing the number of patients who were able to have protocol treatment and have a bone marrow transplant after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268242
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Anjali Advani, MD||The Cleveland Clinic|