NCT00012259

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of troxacitabine in treating patients who have blast phase chronic myelogenous leukemia.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline
Completed

Started Dec 2000

Shorter than P25 for phase_2 leukemia

Geographic Reach
2 countries

20 active sites

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

December 11, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2001

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2002

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

February 26, 2004

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

March 3, 2001

Last Update Submit

June 7, 2021

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic myelogenous leukemia, BCR-ABL1 positive

Outcome Measures

Primary Outcomes (16)

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 4

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 8

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 12

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 16

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 20

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 24

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 28

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 32

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 36

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 40

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 44

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 48

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 52

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 56

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 60

  • Conventional Response Rate

    Conventional Response Rate defined as the achievement of complete hematologic remission (CHR), partial hematologic remission (PHR), hematologic improvement (HI), partial response (PR), or back to chronic phase (BCP).

    Week 64

Secondary Outcomes (3)

  • Percent of Patients Returning to Chronic Phase

    Throughout the study period of approximately 15 months.

  • Toxicity Profile

    Every 4 weeks throughout the study period of approximately 15 months.

  • Survival Duration

    Throughout the study period of approximately 15 months.

Study Arms (1)

troxacitabine

EXPERIMENTAL
Drug: troxacitabine

Interventions

troxacitabineDRUG
Also known as: 8 mg/m2 administered IV over 30 minutes per day for 5 consecutive days
troxacitabine

Eligibility Criteria

Age16 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of Philadelphia chromosome-positive blastic phase chronic myelogenous leukemia (CML) with blasts of non-lymphoid origin Blastic phase defined as: At least 30% blasts in the blood or bone marrow OR Presence of extramedullary infiltration outside the liver or spleen No leukemic CNS involvement PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL AST or ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine less than 1.8 mg/dL if creatinine clearance at least 45 mL/min Other: No known hypersensitivity to troxacitabine or its analogues No active uncontrolled serious infection No other severe medical condition that would preclude study No neurologic or psychiatric disorders that would preclude informed consent No uncontrolled underlying medical condition or underlying condition that could be aggrevated by treatment Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 24 hours since prior hydroxyurea Prior STI571 for blastic phase chronic myelogenous leukemia allowed No other prior chemotherapy for blastic phase disease Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 14 days since prior investigational agents and recovered No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (20)

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Cedars-Sinai Comprehensive Cancer Center

Los Angeles, California, 90048, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

Northwestern University Medical Center

Chicago, Illinois, 60611, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231-2410, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Royal Victoria Hospital - Montreal

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

LeukemiaBlast CrisisLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

troxacitabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2001

First Posted

February 26, 2004

Study Start

December 11, 2000

Primary Completion

March 27, 2002

Study Completion

March 27, 2002

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations

US(15)CA(5)