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Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)

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ClinicalTrials.gov Identifier: NCT00114959
Recruitment Status : Terminated (Poor enrollment)
First Posted : June 21, 2005
Results First Posted : January 15, 2015
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( ChemGenex Pharmaceuticals )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myeloid Leukemia, Chronic
Myeloid Leukemia, Chronic, Accelerated-Phase
Blast Phase
Myeloid Leukemia, Chronic, Chronic-Phase
Interventions Drug: Homoharringtonine
Drug: Imatinib Mesylate
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Homoharringtonine + Imatinib Mesylate
Hide Arm/Group Description Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
Period Title: Overall Study
Started 15
Completed 7 [1]
Not Completed 8
Reason Not Completed
Lack of Efficacy             6
Physician Decision             1
Death             1
[1]
protocol definition of completed study is having received >= 4 cycles of treatment
Arm/Group Title Homoharringtonine + Imatinib Mesylate
Hide Arm/Group Description Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
55
(21 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
7
  46.7%
Male
8
  53.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants
Black 4
Caucasian 10
Hispanic 1
1.Primary Outcome
Title Proportion of Participants With Accelerated Phase or Blast Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response
Hide Description

Participants in accelerated or blast phase who converted to at least CML-chronic phase.

CML in accelerated phase meets one or more of the following criteria: >=15% - <30% blasts in peripheral blood or bone marrow, >=30% blasts + promyelocytes in peripheral blood or bone marrow, >=20% basophils in peripheral blood; platelet count <100*10^9/L unrelated to therapy or clonal evolution. CML in blast phase have >=30% blasts in the bone marrow or presence of extramedullary disease.

Meaningful responses include (in descending order of health)

  • Complete Hematologic Remission (CHR)
  • Partial Hematologic Remission (PHR)
  • Hematologic Improvement (HI)
  • Partial Response (PR)
  • Return to Chronic Phase (RCP). A return to chronic phase involves the disappearance of blastic phase features and a return to chronic phase CML picture, i.e., peripheral blasts <15%, peripheral blasts and promyelocytes <30%, peripheral basophils <20%, and platelets >100*10^9/L.
Time Frame up to month 4
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.
Arm/Group Title Homoharringtonine + Imatinib Mesylate
Hide Arm/Group Description:
Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Proportion of Participants With Chronic Phase Chronic Myeloid Leukemia (CML) Who Achieve a Meaningful Response
Hide Description

Participants who are not in complete hematologic remission (CHR) at study start must achieve at least a CHR, and participants who are in CHR at onset must demonstrate an improvement in their cytogenetics.

A Complete Hematologic Remission (CHR) involves normalization of the bone marrow (less than 5% blasts) and peripheral blood with white blood cells < 10*10^9/L, absolute neutrophil count >=1*10^9/L, platelets >=100*10^9/L and no peripheral blasts, promyelocytes or myelocytes. This is in addition to disappearance of all signs and symptoms of the disease.

Time Frame up to month 4
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.
Arm/Group Title Homoharringtonine + Imatinib Mesylate
Hide Arm/Group Description:
Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Number of Participants With Adverse Experiences (AEs)
Hide Description

Summary of participants who had adverse events (AEs), who discontinued treatment due to the AE, who had serious adverse events (SAEs), and who had SAEs that were related to treatments.

A serious adverse event is one that at any dose of the study drug or at any time during the period of observation:

  • Results in death;
  • Is life threatening;
  • Requires inpatient hospitalization or prolongation of existing hospitalization;
  • Results in persistent or significant disability/incapacity;
  • Is a congenital anomaly/birth defect;
  • Is medically important.

The Investigator assessed each AE for potential causal relationship between the event and study drug. An investigator assessment of possibly, probably or unknown relation is considered related.

Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants
Arm/Group Title Homoharringtonine + Imatinib Mesylate
Hide Arm/Group Description:
Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
AEs 15
Discontinued due to AE 2
Serious AEs 12
SAEs considered related 7
4.Secondary Outcome
Title Participants With Complete Hematologic Remission Suppression of the Philadelphia Chromosome
Hide Description

Complete hematologic remission was further classified according to the suppression of the Philadelphia chromosome (Ph) as:

No cytogenetic response - Ph positive 100% Minimal cytogenetic response - Ph positive 35-90% Partial cytogenetic response - Ph positive 1-34% Complete cytogenetic response - Ph positive 0%

Time Frame up to month 4
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed since the study was intended to follow a Simon two stage design to test 18 participants in each stratum (chronic, accelerated and blast phases) for efficacy. Enrollment was insufficient.
Arm/Group Title Homoharringtonine + Imatinib Mesylate
Hide Arm/Group Description:
Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Day 1 up to 3 years (30 days past last dose)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Homoharringtonine + Imatinib Mesylate
Hide Arm/Group Description Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
All-Cause Mortality
Homoharringtonine + Imatinib Mesylate
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Homoharringtonine + Imatinib Mesylate
Affected / at Risk (%)
Total   12/15 (80.00%) 
Blood and lymphatic system disorders   
Neutropenic fever  1  3/15 (20.00%) 
Febrile neutropenia  1  1/15 (6.67%) 
Cardiac disorders   
Atrial fibrillation  1  1/15 (6.67%) 
Gastrointestinal disorders   
Gastrointestinal bleeding  1  1/15 (6.67%) 
Hemorrhage, gastrointestinal  1  1/15 (6.67%) 
General disorders   
Fever  1  2/15 (13.33%) 
Infection  1  1/15 (6.67%) 
Weakness  1  1/15 (6.67%) 
Sudden death  1  1/15 (6.67%) 
Death  1  1/15 (6.67%) 
Injury, poisoning and procedural complications   
Fatal car accident  1  1/15 (6.67%) 
Investigations   
Leukocytosis  1  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/15 (6.67%) 
Pain, upper extremities  1  1/15 (6.67%) 
Pain, low back  1  1/15 (6.67%) 
Nervous system disorders   
Dizziness  1  1/15 (6.67%) 
Renal and urinary disorders   
Renal failure  1  1/15 (6.67%) 
Acute renal failure  1  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/15 (6.67%) 
Vascular disorders   
Cerebral vascular event (fatal)  1  1/15 (6.67%) 
Hypotension  1  2/15 (13.33%) 
Intra-cranial hemorrhage  1  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Homoharringtonine + Imatinib Mesylate
Affected / at Risk (%)
Total   15/15 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  9/15 (60.00%) 
Bruising  1  1/15 (6.67%) 
Abdominal bruising, secondary to SC injections  1  2/15 (13.33%) 
Decreased prothrombinemia  1  1/15 (6.67%) 
Ecchymoses, mouth and arms  1  1/15 (6.67%) 
Hematoma  1  1/15 (6.67%) 
Hepatitis A  1  1/15 (6.67%) 
Hypertriglyceridemia  1  1/15 (6.67%) 
Intermittent anemia  1  1/15 (6.67%) 
Myelosuppression  1  5/15 (33.33%) 
Neutropenia  1  8/15 (53.33%) 
Neutropenic fever  1  2/15 (13.33%) 
Nosebleed  1  2/15 (13.33%) 
Pancytopenia  1  3/15 (20.00%) 
Petechiae  1  2/15 (13.33%) 
Petechiae abdomen  1  1/15 (6.67%) 
Petechiae head, arms, neck, oral  1  1/15 (6.67%) 
Petechiae thigh  1  1/15 (6.67%) 
Thrombocytopenia  1  8/15 (53.33%) 
Thrombocytopenia, intermittent  1  5/15 (33.33%) 
Ear and labyrinth disorders   
Worsening otitis media  1  1/15 (6.67%) 
Eye disorders   
Conjunctival melanosis  1  1/15 (6.67%) 
Itchy eyes  1  1/15 (6.67%) 
Gastrointestinal disorders   
Fluid retention  1  2/15 (13.33%) 
Abdominal bloating  1  1/15 (6.67%) 
Abdominal discomfort intermittent  1  1/15 (6.67%) 
Abdominal pain  1  3/15 (20.00%) 
Abdominal pain, interrmittent left sided  1  1/15 (6.67%) 
Anorexia  1  1/15 (6.67%) 
Colon polyps  1  2/15 (13.33%) 
Constipation  1  2/15 (13.33%) 
Constipation, intermittent  1  1/15 (6.67%) 
Diarrhea  1  7/15 (46.67%) 
Dry heaves  1  1/15 (6.67%) 
Flatus  1  1/15 (6.67%) 
Gastritis  1  1/15 (6.67%) 
GERD  1  1/15 (6.67%) 
Hemorrhoids  1  1/15 (6.67%) 
Hepatic Dysfunction  1  1/15 (6.67%) 
Indigestion  1  1/15 (6.67%) 
Lack of appetite  1  1/15 (6.67%) 
Poor appetite  1  2/15 (13.33%) 
Suppressed appetite  1  1/15 (6.67%) 
Loose stools  1  3/15 (20.00%) 
Melena  1  1/15 (6.67%) 
Mild nausea  1  1/15 (6.67%) 
Nausea  1  8/15 (53.33%) 
Nausea, intermittent  1  1/15 (6.67%) 
Pandiverticulosis  1  1/15 (6.67%) 
Rectal bleeding  1  1/15 (6.67%) 
Renal failure  1  1/15 (6.67%) 
Stomach discomfort  1  1/15 (6.67%) 
Upset stomach  1  1/15 (6.67%) 
Vomiting  1  11/15 (73.33%) 
Vomiting, occasional  1  1/15 (6.67%) 
General disorders   
Allergies  1  1/15 (6.67%) 
Bacteremia  1  1/15 (6.67%) 
Bleeding at CVC site  1  1/15 (6.67%) 
Bleeding at PICC line insertion site  1  1/15 (6.67%) 
Bleeding at port site  1  1/15 (6.67%) 
Bruising  1  2/15 (13.33%) 
Chills  1  2/15 (13.33%) 
Chills, intermittent  1  1/15 (6.67%) 
Citrobacter freundii positive  1  1/15 (6.67%) 
Fatigue  1  7/15 (46.67%) 
Mild fatigue  1  4/15 (26.67%) 
Severe fatigue  1  1/15 (6.67%) 
Fever  1  2/15 (13.33%) 
Fibromyalgia syndrome  1  1/15 (6.67%) 
Generalized achiness  1  1/15 (6.67%) 
Intermittent fatigue  1  1/15 (6.67%) 
Intermittent fever  1  1/15 (6.67%) 
Mild fever  1  1/15 (6.67%) 
Pain, left flank  1  1/15 (6.67%) 
Pain, left upper quadrant  1  1/15 (6.67%) 
Pain, right hip  1  1/15 (6.67%) 
Pallor  1  1/15 (6.67%) 
Runny nose  1  1/15 (6.67%) 
Weakness  1  1/15 (6.67%) 
Mildly weak  1  1/15 (6.67%) 
Edema  1  2/15 (13.33%) 
Edema, intermittent  1  1/15 (6.67%) 
Edema, pedal  1  1/15 (6.67%) 
Edema, ankle  1  2/15 (13.33%) 
Edema, bilateral  1  1/15 (6.67%) 
Edema, bilateral pedal  1  1/15 (6.67%) 
Edema, bilateral legs + 2 pitting  1  1/15 (6.67%) 
Edema, bilateral lower extremity  1  3/15 (20.00%) 
Edema, lower extremity  1  2/15 (13.33%) 
Edema, peripheral  1  2/15 (13.33%) 
Edema, Intermittent trace peripheral  1  1/15 (6.67%) 
Palpitations  1  1/15 (6.67%) 
Periorbital edema  1  1/15 (6.67%) 
Right Arm Swelling  1  1/15 (6.67%) 
Right side face swelling  1  1/15 (6.67%) 
Swelling, hands and feet  1  1/15 (6.67%) 
Swelling, right arm  1  1/15 (6.67%) 
Bleeding gums  1  4/15 (26.67%) 
Gum soreness  1  1/15 (6.67%) 
Gum tenderness  1  1/15 (6.67%) 
Lip bleeding  1  1/15 (6.67%) 
Loss of taste  1  1/15 (6.67%) 
Malodor, secondary to right groin hematoma  1  1/15 (6.67%) 
Mucositis  1  1/15 (6.67%) 
Oral ulcer  1  1/15 (6.67%) 
Right Ear Pressure  1  1/15 (6.67%) 
Sinus drainage  1  1/15 (6.67%) 
Throat pain  1  1/15 (6.67%) 
Infections and infestations   
Infection, Staphylococcus aureus  1  1/15 (6.67%) 
Pseudomonas aeruginosa  1  1/15 (6.67%) 
Staph infection right nostril  1  1/15 (6.67%) 
Investigations   
Hemoglobin decreased  1  1/15 (6.67%) 
Leukocytosis  1  1/15 (6.67%) 
Severe thrombocytopenia  1  1/15 (6.67%) 
Elevated BUN  1  1/15 (6.67%) 
Elevated PTT  1  1/15 (6.67%) 
Decreased hemaglobin  1  1/15 (6.67%) 
Elevated creatinine  1  1/15 (6.67%) 
Elevated LDH  1  1/15 (6.67%) 
Metabolism and nutrition disorders   
Decreased appetite  1  2/15 (13.33%) 
Dehydration  1  1/15 (6.67%) 
Goiter, nodular  1  1/15 (6.67%) 
Hot flashes  1  1/15 (6.67%) 
Hyperglycemia  1  1/15 (6.67%) 
Hyperphosphatemia  1  2/15 (13.33%) 
Hypermagnesemia  1  1/15 (6.67%) 
Hypokalemia  1  4/15 (26.67%) 
Hypomagnesemia  1  4/15 (26.67%) 
Hypomagnesium  1  2/15 (13.33%) 
Uricemia  1  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders   
Aching all over  1  1/15 (6.67%) 
Bilateral upper pain - extremities  1  1/15 (6.67%) 
Cellulitis, left arm  1  1/15 (6.67%) 
Chest pain  1  1/15 (6.67%) 
Chest pressure  1  1/15 (6.67%) 
Cramps right leg, right arm  1  1/15 (6.67%) 
Cramps, muscle  1  1/15 (6.67%) 
Cramps, neck  1  1/15 (6.67%) 
Cramps, pedal muscle bilateral  1  1/15 (6.67%) 
Dental abscesses  1  1/15 (6.67%) 
Diffused bone pain  1  1/15 (6.67%) 
Left hip and leg pain, secondary to bone marrow aspiration  1  1/15 (6.67%) 
Leg muscle soreness  1  1/15 (6.67%) 
Leg trembling on standing  1  1/15 (6.67%) 
Pain, bilateral knee  1  1/15 (6.67%) 
Pain, bilateral shoulder  1  2/15 (13.33%) 
Pain, bone  1  2/15 (13.33%) 
Pain, knee  1  1/15 (6.67%) 
Pain, left knee  1  1/15 (6.67%) 
Pain, left great toe  1  1/15 (6.67%) 
Pain, low back  1  1/15 (6.67%) 
Pain, muscle  1  1/15 (6.67%) 
Pain, back and shoulder  1  1/15 (6.67%) 
Pain, neck  1  1/15 (6.67%) 
Pain, upper extremities  1  1/15 (6.67%) 
Teeth sensitivity  1  1/15 (6.67%) 
Tooth pain  1  1/15 (6.67%) 
Nervous system disorders   
Anxiety  1  1/15 (6.67%) 
Bad dreams  1  1/15 (6.67%) 
Confusion  1  1/15 (6.67%) 
Mild confusion  1  1/15 (6.67%) 
Dizziness  1  1/15 (6.67%) 
Dizziness, fentanyl  1  1/15 (6.67%) 
Dysphagia  1  1/15 (6.67%) 
Headache  1  6/15 (40.00%) 
Headache/migraine, intermittent right side  1  1/15 (6.67%) 
Headache, sinus  1  1/15 (6.67%) 
Insomnia  1  1/15 (6.67%) 
Light headed  1  2/15 (13.33%) 
Neuropathy, bipedal  1  1/15 (6.67%) 
Neuropathy, hands and feet  1  1/15 (6.67%) 
Peripheral neuropathy, secondary to diabetes  1  1/15 (6.67%) 
Night sweats  1  2/15 (13.33%) 
Numbness, toe  1  1/15 (6.67%) 
Numbness/tingling in extremities  1  1/15 (6.67%) 
Syncope  1  1/15 (6.67%) 
Renal and urinary disorders   
Dark urine  1  1/15 (6.67%) 
Urinary tract infection  1  3/15 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  1/15 (6.67%) 
Cough  1  5/15 (33.33%) 
Dry throat  1  1/15 (6.67%) 
Dyspnea  1  3/15 (20.00%) 
Klebsiella pneumonia  1  1/15 (6.67%) 
Pleural effusion  1  1/15 (6.67%) 
Pneumonia  1  1/15 (6.67%) 
Pulmonary edema  1  1/15 (6.67%) 
Respiratory infection  1  1/15 (6.67%) 
Short of breath  1  2/15 (13.33%) 
Shortness of breath on exertion  1  1/15 (6.67%) 
Sinus congestion  1  2/15 (13.33%) 
Sinus pain  1  1/15 (6.67%) 
Nasal congestion intermittent, secondary to allergies  1  2/15 (13.33%) 
Sore throat  1  2/15 (13.33%) 
Upper respiratory infection  1  2/15 (13.33%) 
Upper respiratory infection nasal allergies  1  1/15 (6.67%) 
Allergic rhinitis  1  1/15 (6.67%) 
Skin and subcutaneous tissue disorders   
Acanthosis nigricans  1  1/15 (6.67%) 
Bruising skin  1  1/15 (6.67%) 
Dry skin  1  1/15 (6.67%) 
Erythema, left foot  1  1/15 (6.67%) 
Erythema, tonsils  1  1/15 (6.67%) 
Hypopigmentation facial  1  1/15 (6.67%) 
Itching due to transfusion  1  1/15 (6.67%) 
Itching impaired  1  1/15 (6.67%) 
Generalized skin itching  1  2/15 (13.33%) 
Itchy ears  1  1/15 (6.67%) 
Keratoderma, pedal  1  1/15 (6.67%) 
Pedal calluses  1  1/15 (6.67%) 
Mild rash  1  1/15 (6.67%) 
Mouth sores  1  1/15 (6.67%) 
Mouth sores, intermittent  1  1/15 (6.67%) 
Mouth ulcerations  1  1/15 (6.67%) 
Oral white patches  1  1/15 (6.67%) 
Peeling skin, groin  1  1/15 (6.67%) 
Plantar surface skin sensitive  1  1/15 (6.67%) 
Rash  1  1/15 (6.67%) 
Painful, red, swollen rash  1  1/15 (6.67%) 
Rash abdomen  1  1/15 (6.67%) 
Rash, macular / facial  1  1/15 (6.67%) 
Seborrheic keratosis, upper extremity  1  1/15 (6.67%) 
Skin nodule  1  1/15 (6.67%) 
Swelling, face  1  1/15 (6.67%) 
Tinea  1  1/15 (6.67%) 
Punctate lesion right foot dorsom  1  1/15 (6.67%) 
Vesicular lesions, right buttock  1  1/15 (6.67%) 
Yeast infection, buttock  1  1/15 (6.67%) 
Surgical and medical procedures   
Dental extraction  1  1/15 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
This study was intended to follow a Simon two stage design to test 18 patients in each stratum (chronic, accelerated and blast phase) for efficacy. Only 15 were enrolled, an insufficient number for a formal statistical analysis of efficacy.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
EMail: ustevatrials@tevapharm.com
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries ( ChemGenex Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00114959    
Other Study ID Numbers: CGX-635-CML-201
MDACC protocol #2005-0067 ( Other Identifier: M.D. Anderson Cancer Center )
First Submitted: June 20, 2005
First Posted: June 21, 2005
Results First Submitted: January 8, 2015
Results First Posted: January 15, 2015
Last Update Posted: January 15, 2015