Clinical trial NCT00801580: My-HyperCVAD in the Treatment of Relapsed Refractory Adult Acute Lymphoid Leukemia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoid Leukemia
Keywords: relapsed ALL
refractory ALL
relapsed adult acute lymphoid leukemia
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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). The second combination will consist of another intensive chemotherapy regimen (methotrexate and Ara-C \[cytarabine\]).


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
  * 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

Primary outcomes:
measure: Type, frequency, severity, timing and relatedness of adverse events (AE)
timeFrame: weekly
measure: CR rate after any treatment cycle and at the end of the study
timeFrame: monthly
Secondary outcomes:
measure: The percentage of hematological responders after any treatment cycle
timeFrame: monthly
measure: The percentage of cytogenetic and molecular responders after any treatment cycle in patients for whom genetic markers of minimal residual disease are available
timeFrame: monthly
measure: Relapse free survival at month 6 and 12
timeFrame: every 6 months
measure: Overall survival at month 6 and 12
timeFrame: every 6 months
measure: The percentage of patients submitted to SCT after CR re-induction
timeFrame: every 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Institute of Hematology "L. & A. Seragnoli"
Study officials:
References: