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

NCT00801580 | Unknown Phase 2

• 2 other identifiers: ALL0206Eudract: 2007-003884-30
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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 \[cytarabine\]).

Conditions

Lymphoid Leukemia

Keywords

relapsed ALL; refractory ALL; relapsed adult acute lymphoid leukemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

doxorubicin liposomal DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Institute of Hematology "L. & A. Seragnoli"

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Giovanni Martinelli, MD

CONTACT

+39 051 6363829; gmartino@alma.unibo.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

IT (1)