- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01376427
Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years
PROTOCOL TREATMENT for Acute Lymphoblastic Leukemia Ph '(BCR / ABL) POSITIVE PATIENTS AGED> 55 YEARS
This study proposes to provide adequate treatment and is based on current scientific evidence for elderly patients with ALL Bcr / Abl positive.
To determine whether low-dose chemotherapy associated with imatinib or dasatinib has acceptable tolerability in elderly patients.
To determine whether this association can increase the rate and quality of referrals to the results of the literature of imatinib as monotherapy for elderly patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day EV for 5 days (-5 to -1).
Intrathecal treatment (diagnosis and prophylactic / therapeutic) -5 days:
Methotrexate 12 mg
Systemic treatment:
- Imatinib 400 mg daily and continuous VO.
- Vincristine (VCR) 1 mg (absolute dose) EV 1, 8, 15 and 22.
- Dexamethasone (DEX): 10 mg/m2 EV, IM or PO days 1-2, 8-9 days 15-16, 22-23. .
Intrathecal chemotherapy:
Triple therapy was administered with methotrexate (MTX), cytosine arabinoside (ARA-C) and hydrocortisone, days 1, 8, 15 and 22 (five doses total prophylactic between prophase and induction):
MTX 12 mg ARA-C 40 mg Dexamethasone 4 mg
Maintenance during the first year will start after full recovery after induction and after complete reassessment of the disease (including mielograma and Bcr-Abl/Abl or Bcr-Abl/Gus ratio in peripheral blood) and will last until one year from the time of complete remission.
The basic treatment included imatinib 400 mg / day (or dasatinib), mercaptopurine at doses of 50 mg/m2 PO day and methotrexate 20 mg/m2 IM weekly.
One week every 3 months maintenance treatment added a "mini-reinduction" consisting
- VCR: 1 mg (absolute dose), i.v., day 1.
- Dexamethasone 40 mg / day, i.v. or p.o., days 1-2.
- not considered more doses of triple intrathecal therapy. Reinduction only be practiced during the first year after remission, so a total of 4 quarterly.
Maintenance treatment of second year
After the first year of maintenance will perform a complete reassessment of the disease (including myelogram) and if the patient remains in complete remission maintenance will continue (without reinduction) until two years from the time of diagnosis.
Maintenance treatment of third year During the third year after complete remission imatinib administered alone (or dasatinib
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Barcelona
-
Badalona, Barcelona, Spain
- Recruiting
- Hospital Germans Trias i Pujol and all Hospital Pethema
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'positive (Bcr / Abl positive) and previously untreated
Exclusion Criteria:
- Other LAL negative for t (9; 22) and Bcr / Abl.
- biphenotypic acute leukemias or bilinear with t (9; 22).
blast crisis of chronic myeloid leukemia progression during or after polychemotherapy treatment (including allo-BMT) or with inhibitors of tyrosine kinases.
The criteria for exclusion from treatment (but not patient record) any of the following
- General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.
- Lack of consent by the patient to use their clinical d
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy in terms of response rate
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Phytogenic
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Dexamethasone
- Methotrexate
- Vincristine
Other Study ID Numbers
- LAL-07OPH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Lymphoblastic Leukemia Ph Positive
-
EDDC (Experimental Drug Development Centre), A*STAR...Chiltern International Inc.WithdrawnPh+ Acute Lymphoblastic Leukemia (Ph+ALL) | Ph- Acute Lymphoblastic Leukemia (Ph-ALL) | Chronic Myeloid Leukemia Accelerated Phase (CML-AP, Ph+) | Chronic Myeloid Leukemia Blast Crisis (CML-BC, Ph+)United States, Singapore
-
TakedaActive, not recruitingPediatric Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL) | Ph+ Mixed Phenotype Acute Leukemia (MPAL) | Philadelphia Chromosome-Like ALL (Ph-like ALL)United States, France, Korea, Republic of, China, Spain, United Kingdom, Czechia, Portugal, Brazil, Argentina, Italy, Australia, Mexico, Netherlands, Poland
-
PETHEMA FoundationRecruitingAcute Lymphoblastic Leukemia Ph PositiveSpain
-
Stanford UniversityNational Cancer Institute (NCI)CompletedB-cell Adult Acute Lymphoblastic Leukemia (ALL) | Ph-positive Adult Acute Lymphoblastic Leukemia (ALL) | Recurrent Adult Acute Lymphoblastic Leukemia (ALL) | T-cell Adult Acute Lymphoblastic Leukemia (ALL)United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent B Acute Lymphoblastic Leukemia | Refractory B Acute Lymphoblastic Leukemia | Recurrent Ph-Like Acute Lymphoblastic Leukemia | Refractory Ph-Like Acute Lymphoblastic LeukemiaUnited States
-
University of ChicagoRecruitingAcute Lymphoblastic Leukemia | Lymphoblastic Leukemia | ph+ Acute Lymphoblastic LeukemiaUnited States
-
Renato MelaragnoSuspendedAcute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)
-
TakedaActive, not recruitingPhiladelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)United States, China, Spain, Australia, Canada, Argentina, Korea, Republic of, Brazil, Japan, Italy, Mexico, France, Greece, Poland, Russian Federation, Austria, Taiwan, Bulgaria, Finland, Turkey
-
The First Affiliated Hospital of Soochow UniversityNot yet recruitingB Acute Lymphoblastic Leukemia | High Risk Acute Lymphoblastic Leukemia | Ph-Negative ALL
-
Ariad PharmaceuticalsCompletedChronic Myeloid Leukemia | Ph+ Acute Lymphoblastic LeukemiaFrance, Belgium, Australia, Singapore, Germany, Spain, United Kingdom, Netherlands, Italy, Korea, Republic of, Sweden
Clinical Trials on Vincristine
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); Spectrum Pharmaceuticals, IncTerminatedVincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid LeukemiaRecurrent Adult Acute Myeloid LeukemiaUnited States
-
ECOG-ACRIN Cancer Research GroupRecruitingRecurrent Adult Acute Lymphoblastic Leukemia | Recurrent Childhood Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | Refractory Acute Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | Lymphoblasts 5 Percent or More of Bone Marrow Nucleated CellsUnited States
-
Centre Oscar LambretSFCECompleted
-
M.D. Anderson Cancer CenterInex PharmaceuticalsCompletedSoft Tissue Sarcoma | Lymphoma | Leukemia | Osteosarcoma | Wilms' TumorUnited States
-
Nanjing Luye Sike Pharmaceutical Co., Ltd.China Medical University, China; Xijing Hospital; The Second Hospital of Hebei... and other collaboratorsUnknownAdult Acute Lymphoblastic LeukemiaChina
-
Spectrum Pharmaceuticals, IncParexelCompletedAcute Lymphoblastic Leukemia (ALL)United States, Canada, Germany, Israel, United Kingdom
-
Spectrum Pharmaceuticals, IncTerminatedAcute Lymphoblastic Leukemia (ALL)United States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedIntraocular RetinoblastomaUnited States, Canada, Australia, New Zealand, India
-
Dartmouth-Hitchcock Medical CenterTerminatedChronic Lymphocytic Leukemia (CLL)United States
-
Societe Internationale d'Oncologie PediatriqueCompletedPrimary Central Nervous System NeoplasmsFrance, United Kingdom, Italy, Germany, Switzerland, Belgium, Denmark, Norway, Austria, Croatia, Poland, Portugal