Lymphoid LeukemiaPhase 2NCT00801580
My-HyperCVAD in the Treatment of Relapsed Refractory Adult Acute Lymphoid Leukemia
A Phase 2 study testing doxorubicin liposomal in people with Lymphoid Leukemia, run by University of Bologna at 1 site in Italy.
Trial summary
The patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoid Leukemia
- What is being tested?
- doxorubicin liposomal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2008to Sep 2010
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ALL (any type included), in patients who:
- have relapsed after conventional chemotherapy* or,
- are refractory to at least 1 cycle of chemotherapy*
- ECOG Performance score of 0-3
- Adequate hepatic and renal function, as defined by serum transaminases <2.5x ULN, bilirubin <1.5xULN, and creatinine <1.5x ULN.
- Age 18 years or greater.
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- Documentation of written informed consent to participate in the trial.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- at least 3 weeks from prior chemotherapy or other investigational anticancer therapy with full recovery from prior toxicities.
- either men or women, accepting to practice effective contraception during the entire study period unless documentation of infertility exists.
Who cannot join
- Treatment with any investigational agent within 3 weeks prior to study therapy.
- Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
- Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to:
- Presence of central nervous system (CNS) leukemia.
- Active uncontrolled bacterial infection.
- Known human immunodeficiency virus (HIV) infection.
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- Significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months.
- Pregnancy or breast-feeding.
- Malabsorption syndromes
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute of Hematology "L. & A. Seragnoli"
Bologna, 40138
About this study
Official title: Open Label, Non-randomized, Phase II Study on Fractioned Cyclophosphamide, Vincristine, Liposomal Doxorubicin or Doxorubicin, and Dexamethasone (MY HYPER-CVAD) in the Treatment of Relapsed Refractory Adult Acute Lymphoid Leukemia
The patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The second combination will consist of another intensive chemotherapy regimen (methotrexate and Ara-C [cytarabine]).
- Conditions
- Lymphoid Leukemia
- Being tested
- doxorubicin liposomal
- Keywords
- relapsed ALL, refractory ALL, relapsed adult acute lymphoid leukemia
- Medical subject headings
- Leukemia, Lymphoid, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxorubicin liposomalDrug
- Cyclophosphamide
- Mesna
- Methotrexate
- Doxorubicin liposomal
- Vincristine
- Dexamethasone
- Rituximab
- Cytarabine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The second combination will consist of another intensive chemotherapy regimen (methotrexate and Ara-C [cytarabine]). Receives: Drug: doxorubicin liposomal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, frequency, severity, timing and relatedness of adverse events (AE)
Measured: weekly
CR rate after any treatment cycle and at the end of the study
Measured: monthly
Secondary outcomes (5)
The percentage of hematological responders after any treatment cycle
Measured: monthly
The percentage of cytogenetic and molecular responders after any treatment cycle in patients for whom genetic markers of minimal residual disease are available
Measured: monthly
Relapse free survival at month 6 and 12
Measured: every 6 months
Overall survival at month 6 and 12
Measured: every 6 months
The percentage of patients submitted to SCT after CR re-induction
Measured: every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoid 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801580
- Sponsor's protocol ID
- ALL0206
- Other IDs
- Eudract: 2007-003884-30
- Status last verified
- Sep 2009
- First submitted
- 2 Dec 2008
- Last updated
- 15 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Non-randomized, Phase II Study on Fractioned Cyclophosphamide, Vincristine, Liposomal Doxorubicin or Doxorubicin, and Dexamethasone (MY HYPER-CVAD) in the Treatment of Relapsed Refractory Adult Acute Lymphoid Leukemia
- ClinicalTrials.gov ID
- NCT00801580
- Acronym / sponsor ID
- ALL0206
- Conditions
- Lymphoid Leukemia
- Keywords
- relapsed ALL, refractory ALL, relapsed adult acute lymphoid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 3 Dec 2008 (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 patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The second combination will consist of another intensive chemotherapy regimen (methotrexate and Ara-C [cytarabine]).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: doxorubicin liposomalThe patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The second combination will consist of another intensive chemotherapy regimen (methotrexate and Ara-C [cytarabine]). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of ALL (any type included), in patients who:
- ECOG Performance score of 0-3
- Adequate hepatic and renal function, as defined by serum transaminases <2.5x ULN, bilirubin <1.5xULN, and creatinine <1.5x ULN.
- Age 18 years or greater.
- Documentation of written informed consent to participate in the trial.
Key exclusion criteria (9 listed)
- Treatment with any investigational agent within 3 weeks prior to study therapy.
- Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
- Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to:
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 |
|---|---|---|
| doxorubicin liposomal* Cyclophosphamide * Mesna * Methotrexate * Doxorubicin liposomal * Vincristine * Dexamethasone * Rituximab * Cytarabine | Drug | 1 |
Primary outcome
Type, frequency, severity, timing and relatedness of adverse events (AE)
Time frame: weekly
CR rate after any treatment cycle and at the end of the study
Time frame: monthly
5 secondary outcomes
The percentage of hematological responders after any treatment cycle
Time frame: monthly
The percentage of cytogenetic and molecular responders after any treatment cycle in patients for whom genetic markers of minimal residual disease are available
Time frame: monthly
Relapse free survival at month 6 and 12
Time frame: every 6 months
Overall survival at month 6 and 12
Time frame: every 6 months
The percentage of patients submitted to SCT after CR re-induction
Time frame: every 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
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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 2 study testing doxorubicin liposomal in people with Lymphoid Leukemia, run by University of Bologna at 1 site in Italy.
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 10 inclusion and 9 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 Sep 2009. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Giovanni Martinelli, MD (+39 051 6363829, gmartino@alma.unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, frequency, severity, timing and relatedness of adverse events (AE) (time frame: weekly). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2009.