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

NCT ID: NCT00801580

Last Updated: 2009-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2010-09-30

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]).

Conditions

Lymphoid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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 \[cytarabine\]).

Group Type: EXPERIMENTAL

doxorubicin liposomal

Intervention Type: DRUG

• Cyclophosphamide
• Mesna
• Methotrexate
• Doxorubicin liposomal
• Vincristine
• Dexamethasone
• Rituximab
• Cytarabine

Interventions

doxorubicin liposomal

• Cyclophosphamide
• Mesna
• Methotrexate
• Doxorubicin liposomal
• Vincristine
• Dexamethasone
• Rituximab
• Cytarabine

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Institute of Hematology "L. & A. Seragnoli" - University of Bologna

Locations

Institute of Hematology "L. & A. Seragnoli"

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giovanni Martinelli, MD

Role: CONTACT

gmartino@alma.unibo.it

+39 051 6363829

Other Identifiers

Eudract: 2007-003884-30

Identifier Type: -

Identifier Source: secondary_id

ALL0206

Identifier Type: -

Identifier Source: org_study_id