Acute Lymphoblastic Leukemia Ph PositiveNCT01376427
Treatment of Acute Lymphoblastic Leukemia Ph '(BCR / ABL) Positive Patients Aged > 55 Years
A study testing Dexamethasone, Methotrexate and Vincristine in people with Acute Lymphoblastic Leukemia Ph Positive, run by PETHEMA Foundation at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia Ph Positive
- What is being tested?
- Dexamethasone, Methotrexate and Vincristine
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2007to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'positive (Bcr / Abl positive) and previously untreated
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Germans Trias i Pujol and all Hospital Pethema
Badalona, Barcelona
Jose Mª Ribera, Dr, jribera@iconcologia.net
About this study
Official title: 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
Read the 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
- Conditions
- Acute Lymphoblastic Leukemia Ph Positive
- Being tested
- Dexamethasone, Methotrexate, Vincristine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone
MethotrexateDrug
Methotrexate
VincristineDrug
Vincristine
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in terms of response rate
Measured: 5 years
Secondary outcomes (1)
Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJan 2007
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia Ph PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376427
- Sponsor's protocol ID
- LAL-07OPH
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2011
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ribera JM, Garcia O, Fernandez-Abellan P, Lavilla E, Bernal MT, Gonzalez-Campos J, Brunet S, Monteserin MC, Montesinos P, Sarra J, Calbacho M, Alvarez-Larran A, Tormo M, Oriol A; PETHEMA Group. Lack of negative impact of Philadelphia chromosome in older patients with acute lymphoblastic leukaemia in the thyrosine kinase inhibitor era: comparison of two prospective parallel protocols. Br J Haematol. 2012 Nov;159(4):485-8. doi: 10.1111/bjh.12043. Epub 2012 Sep 12. No abstract available.
PubMed 22966847
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTOCOL TREATMENT for Acute Lymphoblastic Leukemia Ph '(BCR / ABL) POSITIVE PATIENTS AGED> 55 YEARS
- ClinicalTrials.gov ID
- NCT01376427
- Acronym / sponsor ID
- LAL-07OPH
- Conditions
- Acute Lymphoblastic Leukemia Ph Positive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Jan 2007 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults over 55 years diagnosed with acute lymphoblastic leukemia Ph 'positive (Bcr / Abl positive) and previously untreated
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneDexamethasone | Drug | – |
| MethotrexateMethotrexate | Drug | – |
| VincristineVincristine | Drug | – |
Primary outcome
Efficacy in terms of response rate
Time frame: 5 years
1 secondary outcome
Number of Participants with Adverse Events treated with chemotherapy and dasatinib combination
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 22966847Ribera JM, Garcia O, Fernandez-Abellan P, Lavilla E, Bernal MT, Gonzalez-Campos J, Brunet S, Monteserin MC, Montesinos P, Sarra J, Calbacho M, Alvarez-Larran A, Tormo M, Oriol A; PETHEMA Group. Lack of negative impact of Philadelphia chromosome in older patients with acute lymphoblastic leukaemia in the thyrosine kinase inhibitor era: comparison of two prospective parallel protocols. Br J Haematol. 2012 Nov;159(4):485-8. doi: 10.1111/bjh.12043. Epub 2012 Sep 12. No abstract available.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone, Methotrexate and Vincristine in people with Acute Lymphoblastic Leukemia Ph Positive, run by PETHEMA Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in terms of response rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01376427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.