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Status unknownNCT00801580Updated Sep 15, 2009

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

A Phase 2 interventional study of doxorubicin liposomal in Lymphoid Leukemia, sponsored by University of Bologna. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-09-15.

Sponsored by University of Bologna · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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]).

02

Conditions studied

  • Lymphoid Leukemia

Keywords

  • relapsed ALL
  • refractory ALL
  • relapsed adult acute lymphoid leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 3 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

University of Bologna is the lead sponsor of 153 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (estimated)

Study arms

  • 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

Interventions

  • Drugdoxorubicin liposomal

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

06

What researchers measure

Primary outcomes

  1. Type, frequency, severity, timing and relatedness of adverse events (AE)

    Time frame: weekly

  2. CR rate after any treatment cycle and at the end of the study

    Time frame: monthly

Secondary outcomes

  1. The percentage of hematological responders after any treatment cycle

    Time frame: monthly

  2. 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

  3. Relapse free survival at month 6 and 12

    Time frame: every 6 months

  4. Overall survival at month 6 and 12

    Time frame: every 6 months

  5. The percentage of patients submitted to SCT after CR re-induction

    Time frame: every 6 months

07

Study locations

1 of 1 sites recruiting
  • Institute of Hematology "L. & A. Seragnoli"
    Bologna, 40138, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00801580
Lead sponsor
University of Bologna
First posted
Dec 3, 2008
Start date
Mar 2008
Primary completion
Sep 2010 (estimated)
Completion
Sep 2010 (estimated)
Last update
Sep 15, 2009

Study contacts

Giovanni Martinelli, MD
Contact
gmartino@alma.unibo.it
+39 051 6363829
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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