Number of Participants With a Major Molecular Response at 12 Months
Primary
· 12 months
Major Molecular Response (MMR) is BCR-ABL/ABL ratio \</= 0.05
| Group | Value | 95% CI |
|---|---|---|
| Dasatinib | 103 |
Last reviewed · How we verify
NCT00254423
Dasatinib in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia
Completed
Phase 2
Results posted
Last updated 15 January 2026
What this trial tests
Phase 2 trial testing Dasatinib in Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive in 150 participants. Completed in 14 March 2025.
Timeline
8 November 2005
Primary endpoint
14 March 2025
14 March 2025
14 March 2025
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 8 November 2005 |
| Primary completion | 14 March 2025 |
| Estimated completion | 14 March 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dasatinib (dasatinib) — full drug profile →
Conditions studied
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive — all drugs for Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive →
- Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia — all drugs for Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
16 and older, any sex, with Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive or Philadelphia Chromosome Positive, BCR-ABL1 Positive Chronic Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Survival
Secondary
· Up to 19 years, 4 months and 6 days
Time from date of treatment start until date of death due to any cause or last Follow-up.
| Group | Value | 95% CI |
|---|---|---|
| Dasatinib | NA | 0.3 – 232 |
Participants With Complete Cytogenic Response (CCR)
Secondary
· Up to 19 years, 4 months and 6 days
Complete Cytogenic Response (CCR) is Ph positive 0%
| Group | Value | 95% CI |
|---|---|---|
| Dasatinib | 140 |
Participants Who Developed the ABL Mutations
Secondary
· Up to 19 years, 4 months and 6 days
ABL mutations will be assesses during treatment through Quanitiative PCR (qPCR) (RT-qPCR) or ABM mutational analysis using Sanger Sequencing or next-Generation Sequencing (NGS).
| Group | Value | 95% CI |
|---|---|---|
| Dasatinib | 7 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 19 years, 4 months and 6 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dasatinib
Serious: 34/150 (23%)
Deaths: 4/150
Serious adverse events (40 terms)
| Reaction | System | Dasatinib |
|---|---|---|
| Abdominal Pain | General disorders | — |
| Cellulitis | Infections and infestations | — |
| Chest Pain | General disorders | — |
| Infection | Infections and infestations | — |
| Pancreatitis | Gastrointestinal disorders | — |
| Pneumonia | Infections and infestations | — |
| Cardiac ischemia/infarction | Cardiac disorders | — |
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | — |
| headache | Nervous system disorders | — |
| Pain | General disorders | — |
| Allergic reaction | Immune system disorders | — |
| Allergy-Other : Angioedema/allergic reaction to Enalapril | Immune system disorders | — |
| Allergy-Other : Study drug (Dasatinib) overdose | Immune system disorders | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Atrial Flutter | Cardiac disorders | — |
| Biventricular Heart Failure | Cardiac disorders | — |
| Cardiac Pain | Cardiac disorders | — |
| Cholecystitis | Hepatobiliary disorders | — |
| Congestive Heart Failure | Cardiac disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Encephalopathy | Nervous system disorders | — |
| Fever | General disorders | — |
| Fracture | Injury, poisoning and procedural complications | — |
| Gastritis | Gastrointestinal disorders | — |
| Left distal biceps tendon repair | Surgical and medical procedures | — |
Other adverse events (96 terms — click to expand)
| Reaction | System | Dasatinib |
|---|---|---|
| FATIGUE | General disorders | — |
| DIARRHEA | Gastrointestinal disorders | — |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | — |
| NAUSEA | Gastrointestinal disorders | — |
| PAIN (HEAD/HEADACHE) | Nervous system disorders | — |
| DIZZINESS | Nervous system disorders | — |
| OCULAR VISUAL (OTHER) | Eye disorders | — |
| PAIN (MUSCLE) | General disorders | — |
| CONSTIPATION | Gastrointestinal disorders | — |
| FEVER WITHOUT NEUTROPENIA | General disorders | — |
| VOMITING | Gastrointestinal disorders | — |
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | — |
| EDEMA: LIMB | General disorders | — |
| MUSCULOSKELETAL (OTHER) | Musculoskeletal and connective tissue disorders | — |
| MEMORY IMPAIRMENT | Nervous system disorders | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — |
| GASTROINTESTINAL (OTHER) | Gastrointestinal disorders | — |
| NEUROLOGY (OTHER) | Nervous system disorders | — |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | — |
| DERMATOLOGY/SKIN (OTHER) | Skin and subcutaneous tissue disorders | — |
| HEMOGLOBIN | Blood and lymphatic system disorders | — |
| NEUROPATHY: SENSORY | Nervous system disorders | — |
| BLURRED VISION | Eye disorders | — |
| PLATELETS | Investigations | — |
| CONSTITUTIONAL SYMPTOMS (OTHER) | General disorders | — |
| PAIN (OTHER) | General disorders | — |
| WATERY EYE | Eye disorders | — |
| WATERY EYES | Eye disorders | — |
| ANEMIA | Blood and lymphatic system disorders | — |
| AST SGOT | Investigations | — |
| INSOMNIA | Psychiatric disorders | — |
| MOOD ALTERATION (ANXIETY) | Psychiatric disorders | — |
| PAIN (BONE) | Musculoskeletal and connective tissue disorders | — |
| HYPERTENSION | Vascular disorders | — |
| PAIN (BACK) | Musculoskeletal and connective tissue disorders | — |
| INFECTION (OTHER) | Infections and infestations | — |
| PAIN (ABDOMEN NOS) | Gastrointestinal disorders | — |
| MOOD ALTERATION (DEPRESSION) | Psychiatric disorders | — |
| PAIN (ORAL CAVITY) | Gastrointestinal disorders | — |
| PERIORBITAL EDEMA | Eye disorders | — |
Most-reported serious reactions: Abdominal Pain, Cellulitis, Chest Pain, Infection, Pancreatitis, Pneumonia, Cardiac ischemia/infarction, Gastrointestinal Hemorrhage.
Data from ClinicalTrials.gov NCT00254423 adverse events section.
Sponsor's own description
The goal of this clinical research study is to learn if BMS-354825 (dasatinib) can help to control CML in chronic phase. The safety of this drug will also be studied.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Relative survival in patients with chronic-phase chronic myeloid leukaemia in the tyrosine-kinase inhibitor era: analysis of patient data from six prospective clinical trials.
Sasaki K, Strom SS, O'Brien S, Jabbour E, et al · · 2015 · cited 239× · PMID 26688093 · DOI 10.1016/s2352-3026(15)00048-4 -
Results of dasatinib therapy in patients with early chronic-phase chronic myeloid leukemia.
Cortes JE, Jones D, O'Brien S, Jabbour E, et al · · 2010 · cited 175× · PMID 20008620 · DOI 10.1200/jco.2009.25.4920 -
Early responses predict better outcomes in patients with newly diagnosed chronic myeloid leukemia: results with four tyrosine kinase inhibitor modalities.
Jain P, Kantarjian H, Nazha A, O'Brien S, et al · · 2013 · cited 106× · PMID 23620574 · DOI 10.1182/blood-2013-03-490128 -
Analysis of cardiovascular and arteriothrombotic adverse events in chronic-phase CML patients after frontline TKIs.
Jain P, Kantarjian H, Boddu PC, Nogueras-González GM, et al · · 2019 · cited 89× · PMID 30885996 · DOI 10.1182/bloodadvances.2018025874 -
BCR-ABL1 mutation development during first-line treatment with dasatinib or imatinib for chronic myeloid leukemia in chronic phase.
Hughes TP, Saglio G, Quintás-Cardama A, Mauro MJ, et al · · 2015 · cited 59× · PMID 26118315 · DOI 10.1038/leu.2015.168 -
Clonal chromosomal abnormalities appearing in Philadelphia chromosome-negative metaphases during CML treatment.
Issa GC, Kantarjian HM, Gonzalez GN, Borthakur G, et al · · 2017 · cited 47× · PMID 28835440 · DOI 10.1182/blood-2017-07-792143 -
A prospective analysis of symptom burden for patients with chronic myeloid leukemia in chronic phase treated with frontline second- and third-generation tyrosine kinase inhibitors.
Zulbaran-Rojas A, Lin HK, Shi Q, Williams LA, et al · · 2018 · cited 30× · PMID 30318751 · DOI 10.1002/cam4.1808 -
Conditional survival in patients with chronic myeloid leukemia in chronic phase in the era of tyrosine kinase inhibitors.
Sasaki K, Kantarjian HM, Jain P, Jabbour EJ, et al · · 2016 · cited 28× · PMID 26479889 · DOI 10.1002/cncr.29745
Verify or expand the search:
- PubMed search for NCT00254423
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT00254423 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 15 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00254423.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing