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

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]).

Study Overview

• Status: Unknown
• Conditions: Lymphoid Leukemia
• Intervention / Treatment: Drug: doxorubicin liposomal

• Study Type: Interventional
• Enrollment (Anticipated): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Institute of Hematology "L. & A. Seragnoli"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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]).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Type, frequency, severity, timing and relatedness of adverse events (AE)	weekly
CR rate after any treatment cycle and at the end of the study	monthly

Secondary Outcome Measures

Outcome Measure	Time Frame
The percentage of hematological responders after any treatment cycle	monthly
The percentage of cytogenetic and molecular responders after any treatment cycle in patients for whom genetic markers of minimal residual disease are available	monthly
Relapse free survival at month 6 and 12	every 6 months
Overall survival at month 6 and 12	every 6 months
The percentage of patients submitted to SCT after CR re-induction	every 6 months

Collaborators and Investigators

• Sponsor: University of Bologna

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): September 1, 2010
• Study Completion (Anticipated): September 1, 2010

Study Registration Dates

• First Submitted: December 2, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (Estimate): December 3, 2008

Study Record Updates

• Last Update Posted (Estimate): September 15, 2009
• Last Update Submitted That Met QC Criteria: September 14, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: relapsed ALL; refractory ALL; relapsed adult acute lymphoid leukemia
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: ALL0206; Eudract: 2007-003884-30