NCT00016016

Brief Summary

Phase II trial to study the effectiveness of combining flavopiridol and cytarabine with mitoxantrone in treating patients who have acute leukemia. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

5.8 years

First QC Date

May 6, 2001

Last Update Submit

October 7, 2013

Conditions

Recurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaSecondary Acute Myeloid LeukemiaUntreated Adult Acute Lymphoblastic LeukemiaUntreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity (DLT) as assessed by NCI CTC version 2.0

    Up to 35 days

  • Complete remission (CR)

    Up to 6 years

Study Arms (1)

Treatment (flavopiridol, cytarabine, mitoxantrone)

EXPERIMENTAL

Patients receive flavopiridol IV over 1 hour on days 1-3 and cytarabine IV continuously on days 6-9 followed by mitoxantrone IV over 30-150 minutes on day 9. Patients achieving a partial or complete response after the first course of therapy may receive an additional course of therapy beginning 35 ± 7 days after blood count recovery.

Drug: cytarabineDrug: mitoxantrone hydrochlorideDrug: alvocidibOther: pharmacological studyOther: laboratory procedure

Interventions

cytarabineDRUG

Given IV

Treatment (flavopiridol, cytarabine, mitoxantrone)
mitoxantrone hydrochlorideDRUG

Given IV

Treatment (flavopiridol, cytarabine, mitoxantrone)
alvocidibDRUG

Given IV

Treatment (flavopiridol, cytarabine, mitoxantrone)
pharmacological studyOTHER

Correlative studies

Treatment (flavopiridol, cytarabine, mitoxantrone)
laboratory procedureOTHER

Correlative studies

Treatment (flavopiridol, cytarabine, mitoxantrone)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established diagnoses of poor-risk hematologic malignancies will be considered eligible for this Phase I/II study
  • Pathological confirmation of the diagnosis of AML or ALL
  • ECOG performance status 0,1,2
  • Patients must be able to give informed consent
  • Female patients of childbearing age must have negative pregnancy test
  • AST and ALT =\< 2.5 x normal
  • Alkaline phosphatase =\< 2.5 x normal
  • Bilirubin =\< 1.5 x normal
  • Serum creatinine =\< 2.0 mg/dl
  • Left ventricular ejection fraction must \>= 45% by MUGA or Echocardiogram
  • Acute Myelogenous Leukemia (AML)
  • AML arising from MDS
  • Secondary AML
  • Relapsed or refractory AML, including primary induction failure
  • Acute Lymphoblastic Leukemia (ALL)
  • +4 more criteria

You may not qualify if:

  • Hyperleukocytosis with \>= 50,000 leukemic blasts/mm\^3
  • Active, uncontrolled infection
  • Disseminated intravascular coagulation
  • Active CNS leukemia
  • Concomitant chemotherapy, radiation therapy or immunotherapy
  • Intrinsic impaired cardiac function (MI within the preceding 3 months or history of severe coronary artery disease, cardiomyopathy, CHF \> Class II)
  • History of congestive heart disease, or arrhythmia without regard to time, severity or resolution
  • Women who are pregnant or lactating will not be eligible for this trial, as the investigational agent may be harmful to the developing fetus or nursing infant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287-8936, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Interventions

CytarabineMitoxantronealvocidib

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic Compounds

Study Officials

  • Judith Karp

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2001

First Posted

January 27, 2003

Study Start

February 1, 2001

Primary Completion

November 1, 2006

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)