High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML
Primary Purpose
Myelodysplastic Syndrome, Acute Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ara-C
Mitoxantrone
Etoposide
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia, Myelodysplastic syndrome, Acute myeloid leukemia
Eligibility Criteria
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
Sites / Locations
- The University of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Induction chemotherapy followed by stem cell transplant
Arm Description
Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
Outcomes
Primary Outcome Measures
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
Overall Survival
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.
Secondary Outcome Measures
Feasibility of Stem Cell Collection
Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg
Numbers of Stem Cells Collected
Overall Survival in Patients Undergoing Autologous Stem Cell Transplant
Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant
Full Information
NCT ID
NCT00774046
First Posted
October 15, 2008
Last Updated
January 16, 2014
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00774046
Brief Title
High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML
Official Title
High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for Therapy-Related Myelodysplastic Syndrome/Therapy -Related Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome, Acute Myeloid Leukemia
Keywords
Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia, Myelodysplastic syndrome, Acute myeloid leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Induction chemotherapy followed by stem cell transplant
Arm Type
Experimental
Arm Description
Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
Intervention Type
Drug
Intervention Name(s)
Ara-C
Other Intervention Name(s)
Cytarabine, HiDAC
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Intervention Description
Induction: 30mg/m2 after the end of HiDAC day 1 and day 5
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VP-16
Intervention Description
Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days
Primary Outcome Measure Information:
Title
Response to Induction Chemotherapy (CR or PR)
Description
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
Time Frame
Day 28-40
Title
Overall Survival
Time Frame
Up to 2000 days
Title
Relapse-free Survival
Description
Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality.
Time Frame
Up to 2000 days
Secondary Outcome Measure Information:
Title
Feasibility of Stem Cell Collection
Description
Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg
Time Frame
1-5 days from initiation of stem cell collection
Title
Numbers of Stem Cells Collected
Time Frame
1-5 days from initiation of stem cell collection
Title
Overall Survival in Patients Undergoing Autologous Stem Cell Transplant
Time Frame
Up to 817 days
Title
Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant
Time Frame
Up to 883 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy Godley, M.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High-dose Cytarabine/Mitoxantrone Followed by Autotransplantation for t-MDS/t-AML
We'll reach out to this number within 24 hrs