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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
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

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

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 15, 2008
Last Updated
January 16, 2014
Sponsor
University of Chicago
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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

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

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