Trial Outcomes & Findings for Therapy of Early Chronic Phase CML With Higher-Dose Gleevec, Alpha Interferon, and Low-Dose Ara-C (NCT NCT00038649)
NCT ID: NCT00038649
Last Updated: 2018-10-09
Results Overview
Complete Hematologic Remission (CHR): normalization \>4 weeks of bone marrow (\<5% blasts), peripheral blood with White Blood Cells (WBC) \<10 x 109/L \& no peripheral blasts, promyelocytes or myelocytes; disappearance all signs/symptoms disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly \< 50% of pretreatment, or thrombocytosis \>450x109/L but \<50% of pretreatment. Hematologic surveys twice per year with bone aspirations at discretion of treating physician.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
117 participants
Primary outcome timeframe
Response to imatinib mesylate evaluated after completing 3 - 12 months of therapy.
Results posted on
2018-10-09
Participant Flow
Recruitment Period: June 11, 2001 to April 25, 2003. All recruitment done in medical settings at University of Texas (UT) MD Anderson Cancer Center.
Of the 117 participants enrolled, three were excluded before starting: two (2) withdrew from the study prior to initiation of treatment and one (1) was ineligible.
Participant milestones
| Measure |
Gleevec
Gleevec 400 mg orally twice daily.
|
|---|---|
|
Overall Study
STARTED
|
114
|
|
Overall Study
COMPLETED
|
105
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Gleevec
Gleevec 400 mg orally twice daily.
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
Baseline Characteristics
Therapy of Early Chronic Phase CML With Higher-Dose Gleevec, Alpha Interferon, and Low-Dose Ara-C
Baseline characteristics by cohort
| Measure |
Gleevec
n=114 Participants
Gleevec 400 mg orally twice daily.
|
|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Response to imatinib mesylate evaluated after completing 3 - 12 months of therapy.Complete Hematologic Remission (CHR): normalization \>4 weeks of bone marrow (\<5% blasts), peripheral blood with White Blood Cells (WBC) \<10 x 109/L \& no peripheral blasts, promyelocytes or myelocytes; disappearance all signs/symptoms disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly \< 50% of pretreatment, or thrombocytosis \>450x109/L but \<50% of pretreatment. Hematologic surveys twice per year with bone aspirations at discretion of treating physician.
Outcome measures
| Measure |
Gleevec
n=114 Participants
Gleevec 400 mg orally twice daily.
|
|---|---|
|
Number of Participants With Molecular Response of Complete or Partial Hematologic Remission
CHR
|
110 participants
|
|
Number of Participants With Molecular Response of Complete or Partial Hematologic Remission
PHR
|
0 participants
|
SECONDARY outcome
Timeframe: Response to imatinib mesylate evaluated after completing 3 - 12 months of therapy.Population: Analysis was of the 110 participants who achieved a CHR with a cytogenetic response as described in the outcome measure descriptions.
Number of participants with Complete Hematologic Remission (CHR): normalization \>4 weeks of bone marrow (\<5% blasts), peripheral blood with WBC \<10 x 109/L \& no peripheral blasts, promyelocytes or myelocytes; disappearance all signs/symptoms disease. CHR further classified according to suppression of Philadelphia chromosome (Ph) by cytogenetics or i Fluorescence In Situ Hybridization (FISH): No cytogenetic response - Ph positive 100% of pretreatment value; Minor cytogenetic response - Ph positive 35-90% of pretreatment value; Partial cytogenetic response - Ph positive 1-34% of pretreatment value; Complete cytogenetic response - Ph positive 0%. Hematologic surveys twice per year with bone aspirations at discretion of treating physician.
Outcome measures
| Measure |
Gleevec
n=110 Participants
Gleevec 400 mg orally twice daily.
|
|---|---|
|
Participant Complete Hematologic Remission (CHR) Classified
No cytogenetic response
|
0 participants
|
|
Participant Complete Hematologic Remission (CHR) Classified
Minor cytogenetic response
|
1 participants
|
|
Participant Complete Hematologic Remission (CHR) Classified
Partial cytogenetic response
|
4 participants
|
|
Participant Complete Hematologic Remission (CHR) Classified
Complete cytogenetic response
|
105 participants
|
Adverse Events
Gleevec
Serious events: 45 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gleevec
n=114 participants at risk
Gleevec 400 mg orally twice daily.
|
|---|---|
|
General disorders
Death
|
3.5%
4/114 • Number of events 4 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Arthritis
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Blood and lymphatic system disorders
Bleeding
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Cardiac Arrythmia
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Cardiac; NOS
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Cardiovascular Accident
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Chest Pain
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Diarrhea/Vomiting
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Eye disorders
Eye Irritation
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Renal and urinary disorders
Hematuria
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Musculoskeletal and connective tissue disorders
Hip Replacement Surgery
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Hepatobiliary disorders
Increased Liver Enzymes
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Nausea
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Pericarditis
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Prolapse Colon
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Insufficiency
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Surgical and medical procedures
Rotator cuff Repair
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Reproductive system and breast disorders
Ruptured Ovarian Cyst
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Nervous system disorders
Somnolence
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Surgical and medical procedures
Surgery
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Surgical and medical procedures
Surgery Abdominal Mass
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Nervous system disorders
Syncope
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Vomiting
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Gallbladder disorder - Cholecystectomy
|
1.8%
2/114 • Number of events 2 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Congestive Heart Failure
|
1.8%
2/114 • Number of events 2 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Dehydration
|
1.8%
2/114 • Number of events 2 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Investigations
Fever
|
1.8%
2/114 • Number of events 2 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Left Ventricular Diastolic Dysfunction
|
0.88%
1/114 • Number of events 2 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.88%
1/114 • Number of events 2 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Reproductive system and breast disorders
Pregnancy
|
1.8%
2/114 • Number of events 2 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Atrial Fibrallation
|
2.6%
3/114 • Number of events 3 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Nervous system disorders
Depression
|
2.6%
3/114 • Number of events 3 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
3/114 • Number of events 3 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Gastroenteritis
|
2.6%
3/114 • Number of events 3 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Injury, poisoning and procedural complications
Fall
|
3.5%
4/114 • Number of events 4 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Surgical and medical procedures
Elective Surgery
|
4.4%
5/114 • Number of events 6 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
General disorders
Pain
|
6.1%
7/114 • Number of events 7 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
General disorders
Secondary Malignancy
|
6.1%
7/114 • Number of events 8 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Infections and infestations
Infection
|
7.9%
9/114 • Number of events 10 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Angioplasty
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Cardiac disorders
Coronary artery bypass grafting (CABG) required
|
0.88%
1/114 • Number of events 1 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
Other adverse events
| Measure |
Gleevec
n=114 participants at risk
Gleevec 400 mg orally twice daily.
|
|---|---|
|
Cardiac disorders
Chest Pain
|
7.9%
9/114 • Number of events 9 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
6/114 • Number of events 6 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
6/114 • Number of events 6 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Infections and infestations
Infection
|
7.9%
9/114 • Number of events 10 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
Surgical and medical procedures
Elective Surgery
|
5.3%
6/114 • Number of events 7 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
General disorders
Pain
|
6.1%
7/114 • Number of events 7 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
|
General disorders
Secondary Malignancy
|
6.1%
7/114 • Number of events 8 • Total duration of therapy anticipated to be 15-20 years. Adverse events were collected from initiation of treatment, every 6 months yearly. Overall study period was June 2001 to August 2013.
|
Additional Information
Jorge Cortes, MD/Professor, Leukemia Department
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-794-5783
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place