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

Phase 2

Completed

• Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome
• Interventions: Drug: Ara-C; Drug: Mitoxantrone; Drug: Etoposide

• Registration Number: NCT00774046
• Lead Sponsor: University of Chicago

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-12-17
• Results First Submitted QC: 2013-06-20
• Results First Posted: 2013-06-24
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-16
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Induction chemotherapy followed by stem cell transplant	Ara-C	Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
Induction chemotherapy followed by stem cell transplant	Mitoxantrone	Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
Induction chemotherapy followed by stem cell transplant	Etoposide	Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant

Primary Outcome Measures

Name	Time	Method
Response to Induction Chemotherapy (CR or PR)	Day 28-40	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
Overall Survival	Up to 2000 days
Relapse-free Survival	Up to 2000 days	Relapse is defined as bone marrow blasts \>5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.

Secondary Outcome Measures

Name	Time	Method
Feasibility of Stem Cell Collection	1-5 days from initiation of stem cell collection	Feasibility is the ability to cryopreserve \>=2.0 x 10\^6 CD34+ cells/kg
Numbers of Stem Cells Collected	1-5 days from initiation of stem cell collection
Overall Survival in Patients Undergoing Autologous Stem Cell Transplant	Up to 817 days
Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant	Up to 883 days

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States