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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00801580
• Date of registration: 02/12/2008
• Prospective Registration: No
• Primary sponsor: University of Bologna
• Public title: My-HyperCVAD in the Treatment of Relapsed Refractory Adult Acute Lymphoid Leukemia
• Scientific 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
• Date of first enrolment: March 2008
• Target sample size: 3
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00801580
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Italy

Contacts

• Name: Giovanni Martinelli, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoid Leukemia

Intervention(s)

Drug: doxorubicin liposomal

Primary Outcome(s)

CR rate after any treatment cycle and at the end of the study [Time Frame: monthly]

Type, frequency, severity, timing and relatedness of adverse events (AE) [Time Frame: weekly]

Secondary Outcome(s)

Overall survival at month 6 and 12 [Time Frame: every 6 months]

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]

The percentage of patients submitted to SCT after CR re-induction [Time Frame: every 6 months]

Relapse free survival at month 6 and 12 [Time Frame: every 6 months]

The percentage of hematological responders after any treatment cycle [Time Frame: monthly]

Secondary ID(s)

ALL0206

Eudract: 2007-003884-30

Source(s) of Monetary Support

Please refer to primary and secondary sponsors