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A Phase II Study of Gemcitabine/ Mitoxantrone in Patients With AML in First Relapse

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Study of Gemcitabine/ Mitoxantrone in Patients With AML in First Relapse



- 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

- 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.

Inclusion Criteria


- 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


- ECOG Performance Status 0-2

- Liver enzymes (total bilirubin, 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

- 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate and incomplete blood count recovery

Outcome Description:

Assumptions/ hypothesis: A 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. Four weeks is anticipated for observation for response.Please refere to published Article in Clinical Lymphoma, Myeloma& leukemia December 2010

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Anjali Advani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • recurrent adult acute myeloid leukemia
  • adult acute minimally differentiated myeloid leukemia (M0)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute monocytic leukemia (M5b)
  • adult erythroleukemia (M6a)
  • adult pure erythroid leukemia (M6b)
  • adult acute megakaryoblastic leukemia (M7)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Duke Comprehensive Cancer Center Durham, North Carolina  27710
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195