Acute Lymphoblastic LeukemiaPhase 4NCT01366898
Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)
A Phase 4 study testing Dexamethasona, Idarubicine, ARA-C, Methotrexate in people with Acute Lymphoblastic Leukemia, run by PETHEMA Foundation at 1 site in Spain.
Trial summary
The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Dexamethasona, Idarubicine, ARA-C, Methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2007to Dec 2022
- Phase
- Phase 4
- 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 ALL with chromosome Ph 'negative and naïve
Who cannot join
- L3 ALL with mature B phenotype or cytogenetic abnormalities ALL characteristics of Burkitt type (t [8, 14], t [2, 8], t [8, 22]).
- Biphenotypic acute leukemias and bilinear
- Acute undifferentiated leukemia
- The criteria for exclusion from treatment (but not patient record) any of the following:
- Patients with a history of severe and uncontrolled disease, including:
- Coronary artery disease, valvular or hypertensive heart disease.
Show all 13Show fewer
- Chronic liver disease (active viral or alcoholic).
- Chronic respiratory failure.
- Renal failure not due to the ALL.
- Serious neurological disorder not due to the ALL. f. Improperly controlled diabetes.
- General condition affected (grades 3 and 4 of the WHO scale, see Appendix II), not attributable to the LAL.
- LAL chromosome Ph 'positive (must register even if you follow a specific protocol).
- Lack of consent by the patient to use their medical records.
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
José Mª Ribera, Dr, jribera@iconcologia.net
About this study
Official title: PROTOCOL FOR THE TREATMENT Acute Lymphoblastic Leukemia With Ph 'NEGATIVE IN ELDERLY PATIENTS (> 55 Years)
The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of age or associated diseases). Provide results of a treatment to consider standard against which to compare the results of phase II trials of experimental drugs that undoubtedly will be activated in the coming years
Read the detailed description
Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day IV for 5 days (-5 to -1). Supplementary treatment: hydration minimum 2000 ml/day, allopurinol 300 mg / day, gastric protection (as center), daily monitoring of blood glucose, daily monitoring of renal function. Intrathecal treatment (diagnosis and prophylactic) day -5: 12 mg were administered intrathecal methotrexate. The morphological study of the CSF will be defining initial CNS involvement by LAL. Although it is recommended immunophenotypic study of CSF, the definition of CNS involvement by LAL (and its therapeutic consequences) based on morphological observation of blasts in CSF cytocentrifuge.
Remission induction:
Tolerance prephase period can be used to establish the final indication of treatment (standard protocol or frail patients). Day 0 is free of treatment and is considered as +1 the first day of induction. The total duration of the induction is 30 days, consists of two phases (Phase I, days +1 to +14 and phase II, days +15 to +30). Mandatory testing is considered counting the percentage of blasts in peripheral blood +8 day of induction, a myelogram to day +14 to assess early response and a day +35 to assess the complete remission
(days +1 to +14)
- Vincristine (VCR) 1 mg (absolute dose) IV 1 and 8.
- Idarubicin (IDA): 10 mg (absolute dose) IV 1, 2, 8 and 9.
- Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 IV, 8 to 11 days +15 to +30)
- cyclophosphamide (CFM): 300 mg / m 2 iV in 1 hour 15 to 17. (3 total doses).
- Cytarabine (ARAC): 60 mg / m 2 iV in 1 hour 16 to 19, 23 to 26. (8 total doses).
- Vincristine (VCR) 1 mg (absolute dose) iV 1 and 8.
- Idarubicin (IDA): 10 mg (absolute dose) iV 1, 2, 8 and 9.
- Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 iV, 8 to 11
Consolidation:
Cycles 1, 3, 5 MTX: 1,000 mg/m2, IV infusion of 24 hours day 1 L-ASA. 10,000 IU / m 2 IV or IM Day 2 Cycles 2, 4, 6 ARAC: 1,000 mg/m2, IV in 3 hours on days 1, 3 and 5
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Dexamethasona, Idarubicine, ARA-C, Methotrexate
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasona, Idarubicine, ARA-C, MethotrexateDrug
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Not described Receives: Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate |
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 (2)
Efficacy in terms disease free survival
Measured: 5 years
Efficacy in terms of global survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study start30 Jun 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 LeukemiaStudies 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 4
- 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
- NCT01366898
- Sponsor's protocol ID
- LAL-07OLD
- Status last verified
- Jan 2022
- First submitted
- 2 Jun 2011
- Last updated
- 19 Jan 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 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTOCOL FOR THE TREATMENT Acute Lymphoblastic Leukemia With Ph 'NEGATIVE IN ELDERLY PATIENTS (> 55 Years)
- ClinicalTrials.gov ID
- NCT01366898
- Acronym / sponsor ID
- LAL-07OLD
- Conditions
- Acute Lymphoblastic Leukemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- 30 Jun 2007 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 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.
The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of age or associated diseases). Provide results of a treatment to consider standard against which to compare the results of phase II trials of experimental drugs that undoubtedly will be activated in the coming years
Detailed description
Prephase (days -5 to -1) Dexamethasone 10 mg/m2 bolus day IV for 5 days (-5 to -1). Supplementary treatment: hydration minimum 2000 ml/day, allopurinol 300 mg / day, gastric protection (as center), daily monitoring of blood glucose, daily monitoring of renal function. Intrathecal treatment (diagnosis and prophylactic) day -5: 12 mg were administered intrathecal methotrexate. The morphological study of the CSF will be defining initial CNS involvement by LAL. Although it is recommended immunophenotypic study of CSF, the definition of CNS involvement by LAL (and its therapeutic consequences) based on morphological observation of blasts in CSF cytocentrifuge.
Remission induction:
Tolerance prephase period can be used to establish the final indication of treatment (standard protocol or frail patients). Day 0 is free of treatment and is considered as +1 the first day of induction. The total duration of the induction is 30 days, consists of two phases (Phase I, days +1 to +14 and phase II, days +15 to +30). Mandatory testing is considered counting the percentage of blasts in peripheral blood +8 day of induction, a myelogram to day +14 to assess early response and a day +35 to assess the complete remission
(days +1 to +14)
- Vincristine (VCR) 1 mg (absolute dose) IV 1 and 8.
- Idarubicin (IDA): 10 mg (absolute dose) IV 1, 2, 8 and 9.
- Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 IV, 8 to 11 days +15 to +30)
- cyclophosphamide (CFM): 300 mg / m 2 iV in 1 hour 15 to 17. (3 total doses).
- Cytarabine (ARAC): 60 mg / m 2 iV in 1 hour 16 to 19, 23 to 26. (8 total doses).
- Vincristine (VCR) 1 mg (absolute dose) iV 1 and 8.
- Idarubicin (IDA): 10 mg (absolute dose) iV 1, 2, 8 and 9.
- Dexamethasone (DEX): 10 mg/m2 bolus days 1 and 2 iV, 8 to 11
Consolidation:
Cycles 1, 3, 5 MTX: 1,000 mg/m2, IV infusion of 24 hours day 1 L-ASA. 10,000 IU / m 2 IV or IM Day 2 Cycles 2, 4, 6 ARAC: 1,000 mg/m2, IV in 3 hours on days 1, 3 and 5
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Dexamethasona, Idarubicine, ARA-C, Methotrexate |
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 ALL with chromosome Ph 'negative and naïve
Key exclusion criteria (13 listed)
- L3 ALL with mature B phenotype or cytogenetic abnormalities ALL characteristics of Burkitt type (t [8, 14], t [2, 8], t [8, 22]).
- Biphenotypic acute leukemias and bilinear
- Acute undifferentiated leukemia
- Patients with a history of severe and uncontrolled disease, including:
- General condition affected (grades 3 and 4 of the WHO scale, see Appendix II), 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 |
|---|---|---|
| Dexamethasona, Idarubicine, ARA-C, Methotrexate | Drug | Chemotherapy |
Primary outcome
Efficacy in terms of response rate
Time frame: 5 years
2 secondary outcomes
Efficacy in terms disease free survival
Time frame: 5 years
Efficacy in terms of global survival
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 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 Phase 4 study testing Dexamethasona, Idarubicine, ARA-C, Methotrexate in people with Acute Lymphoblastic Leukemia, 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 13 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 19 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT01366898, 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 19 Jan 2022.