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Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years

This study is currently recruiting participants.
Verified September 2016 by PETHEMA Foundation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376427
First Posted: June 20, 2011
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
PETHEMA Foundation
  Purpose

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


Condition Intervention
Acute Lymphoblastic Leukemia Ph Positive Drug: Dexamethasone Drug: Methotrexate Drug: Vincristine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PROTOCOL TREATMENT for Acute Lymphoblastic Leukemia Ph '(BCR / ABL) POSITIVE PATIENTS AGED> 55 YEARS

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Efficacy in terms of response rate [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination [ Time Frame: 1 year ]

Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dexamethasone
    Dexamethasone
    Drug: Methotrexate
    Methotrexate
    Drug: Vincristine
    Vincristine
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'positive (Bcr / Abl positive) and previously untreated

Exclusion Criteria:

  1. Other LAL negative for t (9; 22) and Bcr / Abl.
  2. biphenotypic acute leukemias or bilinear with t (9; 22).
  3. 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

  4. General condition affected (grades 3 and 4 WHO scale), not attributable to the LAL.
  5. Lack of consent by the patient to use their clinical d
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376427


Locations
Spain
Hospital Germans Trias i Pujol and all Hospital Pethema Recruiting
Badalona, Barcelona, Spain
Contact: Jose Mª Ribera, Dr       jribera@iconcologia.net   
Sponsors and Collaborators
PETHEMA Foundation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Josep m Ribera, Executive secretary of Pethema
ClinicalTrials.gov Identifier: NCT01376427     History of Changes
Other Study ID Numbers: LAL-07OPH
First Submitted: June 2, 2011
First Posted: June 20, 2011
Last Update Posted: April 25, 2017
Last Verified: September 2016

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Methotrexate
Vincristine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents