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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Bologna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00801580
First received: December 2, 2008
Last updated: September 14, 2009
Last verified: September 2009

December 2, 2008
September 14, 2009
March 2008
September 2010   (final data collection date for primary outcome measure)
  • Type, frequency, severity, timing and relatedness of adverse events (AE) [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
  • CR rate after any treatment cycle and at the end of the study [ Time Frame: monthly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00801580 on ClinicalTrials.gov Archive Site
  • The percentage of hematological responders after any treatment cycle [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Relapse free survival at month 6 and 12 [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • Overall survival at month 6 and 12 [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • The percentage of patients submitted to SCT after CR re-induction [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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]).

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoid Leukemia
Drug: doxorubicin liposomal
  • Cyclophosphamide
  • Mesna
  • Methotrexate
  • Doxorubicin liposomal
  • Vincristine
  • Dexamethasone
  • Rituximab
  • Cytarabine
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]).
Intervention: Drug: doxorubicin liposomal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Giovanni Martinelli, MD +39 051 6363829 gmartino@alma.unibo.it
Italy
 
NCT00801580
ALL0206, Eudract: 2007-003884-30
Not Provided
Giovanni Martinelli, Institute of Hematology "L. & A. Seragnoli" - University of Bologna
University of Bologna
Not Provided
Not Provided
University of Bologna
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP