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LeukemiaPhase 2NCT00268242

Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia

A Phase 2 study testing Gemcitabine Hydrochloride and Mitoxantrone Hydrochloride in people with Leukemia, run by The Cleveland Clinic at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
Gemcitabine Hydrochloride and Mitoxantrone Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
Jan 2006to Jul 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: A Phase II Study of Gemcitabine/ Mitoxantrone in Patients With Acute Myeloid Leukemia in First Relapse

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.

Read the detailed description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Conditions
Leukemia
Being tested
Gemcitabine Hydrochloride, Mitoxantrone Hydrochloride
Keywords
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)
Medical subject headings
Leukemia, Congenital Abnormalities, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Monocytic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gemcitabine HydrochlorideDrug

    Also called Gemcitabine

    10 mg/m2/ min IV for 12 hours

  • Mitoxantrone HydrochlorideDrug

    Also called Mitoxantrone

    12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3

Study groups in NCT00268242
Study groupRoleWhat they receive
Gemcitabine + MitoxantroneExperimentalGemcitabine 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.
Receives: Drug: Gemcitabine Hydrochloride; Drug: Mitoxantrone Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Rate

    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).

    Measured: 4 Weeks

  2. Duration of the First Complete Response

    Measured: 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.

Secondary outcomes (4)

  1. Disease-free and Overall Survival

    Measured: 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.

  2. Laboratory Correlates: Immunohistochemistry

    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)

    Measured: Baseline

  3. White Blood Cell Count at Time of Relapse

    Measured: After a CR is achieved, patient will be followed at 3 month intervals for disease progression, typically for up to 5 years.

  4. Percentage of Patients Making it to Bone Marrow Transplant.

    Assessing the number of patients who were able to have protocol treatment and have a bone marrow transplant after treatment.

    Measured: After completion of protocol therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionAug 2010
  4. Study completionJul 2011

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00268242
Sponsor's protocol ID
CASE-CCF-7725
Other IDs
P30CA043703, CASE-CCF-7725
Status last verified
Aug 2015
First submitted
20 Dec 2005
Last updated
22 Feb 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine Hydrochloride and Mitoxantrone Hydrochloride in people with Leukemia, run by The Cleveland Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate (time frame: 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00268242.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.

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