My-HyperCVAD in the Treatment of Relapsed Refractory Adult Acute Lymphoid Leukemia

Lymphoid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00801580
• Other study ID #: ALL0206
• Secondary ID: Eudract: 2007-00
• Status: Recruiting
• Phase: Phase 2
• First received: December 2, 2008
• Last updated: September 14, 2009
• Start date: March 2008
• Est. completion date: September 2010

Study information

• Verified date: September 2009
• Source: University of Bologna
• Contact: Giovanni Martinelli, MD
• Phone: +39 051 6363829
• Email: gmartino[@]alma.unibo.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoid Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• doxorubicin liposomal
Cyclophosphamide Mesna Methotrexate Doxorubicin liposomal Vincristine Dexamethasone Rituximab Cytarabine

Locations

Country	Name	City	State
Italy	Institute of Hematology "L. & A. Seragnoli"	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type, frequency, severity, timing and relatedness of adverse events (AE)		weekly	Yes
Primary	CR rate after any treatment cycle and at the end of the study		monthly	No
Secondary	The percentage of hematological responders after any treatment cycle		monthly	No
Secondary	The percentage of cytogenetic and molecular responders after any treatment cycle in patients for whom genetic markers of minimal residual disease are available		monthly	No
Secondary	Relapse free survival at month 6 and 12		every 6 months	No
Secondary	Overall survival at month 6 and 12		every 6 months	No
Secondary	The percentage of patients submitted to SCT after CR re-induction		every 6 months	No