Study Summary
This trial is testing a combination of drugs to treat leukemia and measure any side effects.
Eligible Conditions
- Chronic Myelogenous Leukemia (CML)
- Chronic Myeloid Leukemia (CML)
- Acute Lymphoblastic Leukemia
- Adult Acute Lymphoblastic Leukemia in Complete Remission
- Philadelphia Chromosome Positive
Treatment Effectiveness
Phase-Based Effectiveness
Phase 2
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Up to 24 months
Month 24
Event-free survival
Up to 24 months
Incidence of grade 3-4 toxicity according to the M.D. Anderson Leukemia-specific Adverse Event Recording and Reporting Guidelines
Month 24
Complete response rate
Disease-specific survival
Overall survival
Trial Safety
Phase-Based Safety
This is further along than 68% of similar trials
Side Effects for
Saline
47%Anemia
41%Nausea
31%Lymphocyte count decreased
28%Fatigue
28%Neutrophil count decreased
28%White blood cell decreased
13%Headache
13%Hypoatremia
13%Platelet count decreased
13%Constipation
13%Paresthesia
9%Cough
9%Alanine aminotransferase increased
9%Hypocalcemia
9%Hypokalemia
9%Myalgia
9%Vomiting
9%Hypoalbuminemia
6%Febrile neutropenia
6%Hypernatremia
6%Mucositis oral
6%Pain
6%Chills
6%Dyspnea
6%Edema Limbs
6%Flank Pain
6%Insomnia
3%Fibrinogen decreased
3%Gastritis
3%Depression
3%Hypomagnesemia
3%Hypotension
3%Non-cardiac chest pain
3%Pain in extremity
3%Palpitations
3%Pruritus
3%Sore Throat
3%Vaginal Infection
3%Wheezing
3%Blurred Vision
3%MRSA positive infection in toe
3%Alkaline phosphatase increased
3%Blood bilirubin increased
3%Allergic rhinitis
3%Anorexia
3%Lung Infection
3%Arthralgia
3%Dermatitis
3%Creatinine increased
3%Diarrhea
3%Esophageal Spasms
3%Hemorrhoids
3%Hyperglycemia
3%Lip Infection
3%Muscle weakness upper limb
3%Rash maculo-papular
3%Urinary Frequency
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
Trial Design
1 Treatment Group
Treatment (combination chemotherapy, ponatinib hydrochloride)
1 of 1
Experimental Treatment
100 Total Participants · 1 Treatment Group
Primary Treatment: Cyclophosphamide · No Placebo Group · Phase 2
Treatment (combination chemotherapy, ponatinib hydrochloride)Experimental Group · 13 Interventions: Dexamethasone, Ponatinib Hydrochloride, Cytarabine, Ponatinib, Doxorubicin, Vincristine Sulfate, Cyclophosphamide, Laboratory Biomarker Analysis, Doxorubicin Hydrochloride, Methotrexate, Prednisone, Vincristine, Rituximab · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Other, Drug, Drug, Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Ponatinib
FDA approved
Cytarabine
FDA approved
Ponatinib
FDA approved
Daunorubicin
FDA approved
Vincristine
FDA approved
Cyclophosphamide
FDA approved
Doxorubicin
FDA approved
Methopterin
Not yet FDA approved
Cortisone
Not yet FDA approved
Vincristine
FDA approved
Rituximab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,849 Previous Clinical Trials
1,793,425 Total Patients Enrolled
Elias JabbourPrincipal InvestigatorM.D. Anderson Cancer Center
15 Previous Clinical Trials
970 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Jabbour, Elias, Nicholas J Short, Farhad Ravandi, Xuelin Huang, Naval Daver, Courtney D DiNardo, Marina Konopleva, et al.. 2018. “Combination of Hyper-cvad with Ponatinib as First-line Therapy for Patients with Philadelphia Chromosome-positive Acute Lymphoblastic Leukaemia: Long-term Follow-up of a Single-centre, Phase 2 Study”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(18)30176-5.
- Jabbour, Elias, Hagop Kantarjian, Farhad Ravandi, Deborah Thomas, Xuelin Huang, Stefan Faderl, Naveen Pemmaraju, et al.. 2015. “Combination of Hyper-cvad with Ponatinib as First-line Therapy for Patients with Philadelphia Chromosome-positive Acute Lymphoblastic Leukaemia: A Single-centre, Phase 2 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)00207-7.
- Jabbour, Elias, Hagop Kantarjian, Farhad Ravandi, Deborah Thomas, Xuelin Huang, Stefan Faderl, Naveen Pemmaraju, et al.. 2015. “Combination of Hyper-cvad with Ponatinib as First-line Therapy for Patients with Philadelphia Chromosome-positive Acute Lymphoblastic Leukaemia: A Single-centre, Phase 2 Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(15)00207-7.
- 2011. "Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01424982.