High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML

Acute Myeloid Leukemia Clinical Trial

Official title:

High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774046
• Other study ID #: 11884A
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2008
• Last updated: January 16, 2014
• Start date: December 2002
• Est. completion date: March 2011

Study information

• Verified date: January 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Patients must have received cytotoxic chemotherapy,radiation,or a drug known to affect the properties of DNA or cell growth for some condition other than acute myeloid leukemia prior to diagnosis.

• Patients must have t-MDS/t-AML

• To be eligible for allogeneic transplantation, patients must have a suitable donor who is HLA compatible.

• Patients must be over the age of 10.

• Patients must be reviewed and discussed at the Leukemia and Transplant Conferences of the Section of Hematology/Oncology.

Exclusion Criteria:

• Patients must not have any other serious medical condition(e.g.uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection)

• Psychiatric condition which would prevent compliance or possibly be worsened by treatment

Study Design

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Ara-C
Induction: 3000mg/m2 IV infusion for day 1 and day 5 Mobilization: within 2 weeks of end of induction therapy - 2000mg/m2 as 2 hour IV infusion once every 12 hours for 3 days (6 doses total)
• Mitoxantrone
Induction: 30mg/m2 after the end of HiDAC day 1 and day 5
• Etoposide
Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to Induction Chemotherapy (CR or PR)	Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made	Day 28-40	No
Primary	Overall Survival		Up to 2000 days	No
Primary	Relapse-free Survival	Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.	Up to 2000 days	No
Secondary	Feasibility of Stem Cell Collection	Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg	1-5 days from initiation of stem cell collection	No
Secondary	Numbers of Stem Cells Collected		1-5 days from initiation of stem cell collection	No
Secondary	Overall Survival in Patients Undergoing Autologous Stem Cell Transplant		Up to 817 days	No
Secondary	Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant		Up to 883 days	No