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
  Purpose

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]).


Condition Intervention Phase
Lymphoid Leukemia
Drug: doxorubicin liposomal
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3
Study Start Date: March 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801580

Contacts
Contact: Giovanni Martinelli, MD +39 051 6363829 gmartino@alma.unibo.it

Locations
Italy
Institute of Hematology "L. & A. Seragnoli" Recruiting
Bologna, Italy, 40138
Sponsors and Collaborators
University of Bologna
  More Information

No publications provided

Responsible Party: Giovanni Martinelli, Institute of Hematology "L. & A. Seragnoli" - University of Bologna
ClinicalTrials.gov Identifier: NCT00801580     History of Changes
Other Study ID Numbers: ALL0206, Eudract: 2007-003884-30
Study First Received: December 2, 2008
Last Updated: September 14, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:
relapsed ALL
refractory ALL
relapsed adult acute lymphoid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
BB 1101
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Liposomal doxorubicin
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014