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A Phase II Study of BMS-354825 in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia, Blast Crisis

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Trial Information

A Phase II Study of BMS-354825 in Subjects With Myeloid Blast Phase Chronic Myeloid Leukemia Resistant to or Intolerant of Imatinib Mesylate


Inclusion Criteria:



- Subjects with myeloid blast phase chronic myeloid leukemia

- Subjects who are either resistant or intolerant of imatinib mesylate

Exclusion Criteria:

- Subjects who are eligible and willing to undergo transplantation

- Serious uncontrolled medical disorder or active infection

- Uncontrolled or significant heart problems, such as congestive heart failure, recent
heart attack, etc

- Subjects receiving medications that may affect heart rhythm

- Other malignancy/cancer other than CML

- History of significant bleeding disorder unrelated to CML

- Pregnant or breastfeeding women (subjects must avoid becoming pregnant)

- Subjects received imatinib within 7 days, interferon or cytarabine within 14 days, a
targeted anticancer medication within 14 days, an antineoplastic agent (other than
hydroxyurea or anagrelide) within 28 days, or any other investigation medication in
28 days

- Subject is receiving medications that affect platelet function or an anticoagulant

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Major and Overall Hematologic Response (MaHR and OHR)

Outcome Description:

MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR are specified in Outcome Measure 2. OHR=best confirmed response of MaHR or minor HR (MiHR). MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts + promyelocytes in bone marrow and <30% blasts + promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea.

Outcome Time Frame:

Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-006

NCT ID:

NCT00101816

Start Date:

December 2004

Completion Date:

March 2008

Related Keywords:

  • Chronic Myeloid Leukemia
  • Blast Crisis
  • Myeloid blast phase Chronic Myeloid Leukemia (CML)
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Local InstitutionChicago, Illinois  
Local InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionPortland, Oregon  
Local InstitutionVancouver, Washington  
Local InstitutionBirmingham, Alabama  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionNew Brunswick, New Jersey  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionAustin, Texas  
Local InstitutionRome, Georgia  
Local InstitutionChattanooga, Tennessee  
Local InstitutionColumbia, Missouri  
Local InstitutionDetroit, Michigan