Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects

NCT00529763 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CA180-160
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 14

Brief Summary

The primary objective of this study is to estimate the major cytogenetic response (MCyR) rate to Dasatinib in subjects with CP CML, complete and overall hematologic response (CHR and OHR) rate in subjects with AD CML or Ph+ ALL who have primary or acquired resistance to imatinib, or are intolerant of imatinib, when administered at 100 mg QD (Chronic CML) or 70mg BID (AP CML and Ph+ALL).

Conditions

Leukemia

Keywords

Chronic Phase, Advanced Phase chronic myeloid leukemia; Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Major Cytogenetic Response (MCyR)

  Major Cytogenetic Response (MCyR) is defined as Complete Cytogenetic Response (CCyR) or Partial Cytogenetic Response (PCyR). CCyR: 0% Ph-chromosome-positive cells in metaphase in bone marrow \[BM\] PCyR: 1-35% Ph-chromosome-positive cells in metaphase in \[BM\].

  From first dose up to approximately 12 months of follow up after dasatinib treatment (data cut-off date: 18-Jun-2010)

• Percentage of Participants With Complete, Major, and Overall Hematologic Response (CHR, MaHR, & OHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Blast Phase CML/Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

  Major hematologic response: (MaHR) = complete hematologic response (CHR) + no evidence of leukemia (NEL). CHR=white blood cells (WBC) ≤upper limit of normal (ULN); absolute neutrophil count (ANC) ≥1,000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes, \<20% basophils \& \<5% myelocytes+metamyelocytes in peripheral blood (PB); BM blasts ≤5%; no extra-medullary involvement/hepatomegaly/splenomegaly. NEL=CHR except platelets ≥20,000/mm3 \& \<100,000/mm3; ANC \>500/mm3 \& \<1,000/mm3. Overall hematologic response (OHR)=CHR+NEL+ return to chronic phase (RTC=\<15% blasts in BM and PB; \<30% blasts+promyelocytes in BM \& PB; \<20% basophils in PB; no extra-medullar disease other than spleen \& liver)

  From first dose up to approximately 12 months of follow up after dasatinib treatment (data cut-off date: 18-Jun-2010)

Secondary Outcomes (15)

• Percentage of Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants With Complete Hematologic Response (CHR)

  From first dose up to approximately 12 months of follow up after dasatinib treatment (data cut-off date: 18-Jun-2010)

• Time to Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants

  From first dose up to the day criteria were first met for CCyR or PCyR, whichever occurred first. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010])

• Duration of Major Cytogenetic Response (MCyR) in Chronic Phase Chronic Myeloid Leukemia (CP - CML) Participants

  From first dose until the date of progression or death. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010])

• Progression-free Survival Among CP CML Participants

  From first dosing date until the time progressive disease (PD) is first documented. (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010])

• Time to Complete and Major Hematologic Response (CHR and MaHR) in Advanced Disease Chronic Myeloid Leukemia (AD CML) and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Participants (Ph+ ALL)

  From first dose of Dasatinib until the first day CHR criteria are met (for all confirmed responses). (Up to approximately 12 months of follow up after dasatinib treatment [data cut-off date: 18-Jun-2010])

Study Arms (1)

1

EXPERIMENTAL

Drug: Dasatinib

Interventions

Dasatinib DRUG

Tablets, Oral, 70 mg BID (AD CML) or 100 mg QD (Chronic CML), once or twice daily dependent on disease stage, until subjects meet discontinuation (DC) criteria for study

Also known as: Sprycel, BMS-354825

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Written Informed Consent
• Men and women, ages 18 years of age or older
• Subjects with Chronic Phase (CP) or Advanced Disease (AD) chronic myeloid leukemia (CML)/Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)
• Subjects resistant/intolerant to imatinib
• Subjects presenting:
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2
• Adequate hepatic function
• Adequate renal function
• Sodium, Potassium, Magnesium, Phosphorus, Calcium higher or equal than the lower limit of normal range

You may not qualify if:

• Women of child bearing potential who are not using adequate birth control
• Women who are pregnant or breastfeeding
• Subjects eligible for stem cell transplantation
• Serious uncontrolled medical disorder or active infection
• Uncontrolled or significant cardiovascular disease
• Concurrent incurable malignancy other than CML
• Subjects who received imatinib, interferon, cytarabine within 7 days or other antineoplastic agents other than hydroxyurea within 14 days before dasatinib, Dasatinib in the past
• History of significant bleeding unrelated to CML

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (14)

Local Institution

Beijing, Beijing Municipality, 100044, China

Location

Local Institution - 0004

Fuzhou, Fujian, 350001, China

Location

Local Institution

Fuzhou, Fujian, 350001, China

Location

Local Institution

Guangzhou, Guangdong, 510515, China

Location

Local Institution

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 0008

Suzhou, Jiangsu, 215006, China

Location

Local Institution

Suzhou, Jiangsu, 215006, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200433, China

Location

Local Institution

Chengdou, Sichuan, 610041, China

Location

Local Institution

Chengdu, Sichuan, 610041, China

Location

Local Institution

Tianjin, Tianjin Municipality, 300020, China

Location

Local Institution - 0009

Hangzhou, Zhejiang, 310003, China

Location

Local Institution

Hangzhou, Zhejiang, 310003, China

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Leukemia

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: September 13, 2007
• First Posted: September 14, 2007
• Study Start: November 17, 2007
• Primary Completion: June 17, 2009
• Study Completion: April 20, 2022
• Last Updated: May 8, 2023
• Results First Posted: April 5, 2011

Record last verified: 2023-04

Locations

CN (14)