CClinicalTrials.gg
Sign In
CompletedNCT00774046Updated Feb 11, 2014Results posted

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

A Phase 2 interventional study of Ara-C and Mitoxantrone in Myelodysplastic Syndrome and Acute Myeloid Leukemia, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2014-02-11.

Sponsored by University of Chicago · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
10 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia

Keywords

  • Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia
  • Myelodysplastic syndrome
  • Acute myeloid leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 32 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Induction chemotherapy followed by stem cell transplant

    Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant

    Drug: Ara-C · Drug: Mitoxantrone · Drug: Etoposide

Interventions

  • DrugAra-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)

    Also known as: Cytarabine, HiDAC

  • DrugMitoxantrone

    Induction: 30mg/m2 after the end of HiDAC day 1 and day 5

  • DrugEtoposide

    Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days

    Also known as: VP-16

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 28-40

  2. Overall Survival

    Time frame: Up to 2000 days

  3. 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.

    Time frame: Up to 2000 days

Secondary outcomes

  1. Feasibility of Stem Cell Collection

    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

  2. Numbers of Stem Cells Collected

    Time frame: 1-5 days from initiation of stem cell collection

  3. Overall Survival in Patients Undergoing Autologous Stem Cell Transplant

    Time frame: Up to 817 days

  4. Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant

    Time frame: Up to 883 days

07

Results

Posted Jun 24, 2013

Participant flow

Screening
Participant flow — Screening
MilestoneInduction Chemotherapy Followed by Stem Cell Transplant
Started116
Completed60
Not completed56
Withdrew: Not eligible56
Enrollment
Participant flow — Enrollment
MilestoneInduction Chemotherapy Followed by Stem Cell Transplant
Started60
Completed32
Not completed28
Withdrew: Desired other therapy/refused28
Induction Therapy
Participant flow — Induction Therapy
MilestoneInduction Chemotherapy Followed by Stem Cell Transplant
Started32
Completed32
Not completed0
Stem Cell Mobilization
Participant flow — Stem Cell Mobilization
MilestoneInduction Chemotherapy Followed by Stem Cell Transplant
Started10
Completed7
Not completed3
Withdrew: Count too low (2), sudden death (1)3
Autologous Transplant
Participant flow — Autologous Transplant
MilestoneInduction Chemotherapy Followed by Stem Cell Transplant
Started4
Completed4
Not completed0

Outcome measures

PrimaryResponse 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

Time frame:
Day 28-40
Reported as:
Number · percentage of participants
Response to Induction Chemotherapy (CR or PR)
percentage of participantsAll Patients
Response to Induction Chemotherapy (CR or PR)81.2 (63.6 to 92.8)
PrimaryOverall Survival
Time frame:
Up to 2000 days
Reported as:
Median · Days
Overall Survival
DaysAll Patients
Overall Survival399 (125 to 812)
PrimaryRelapse-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.

Time frame:
Up to 2000 days
Reported as:
Median · Days
Relapse-free Survival
DaysAll Patients
Relapse-free Survival415 (141 to NA)
SecondaryFeasibility of Stem Cell Collection

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
Reported as:
Number · percentage of participants
Feasibility of Stem Cell Collection
percentage of participantsAll Patients
Feasibility of Stem Cell Collection70 (35 to 93)
SecondaryNumbers of Stem Cells Collected
Time frame:
1-5 days from initiation of stem cell collection
Reported as:
Median · 10^6 CD34+ cells/kg
Numbers of Stem Cells Collected
10^6 CD34+ cells/kgAll Patients
Numbers of Stem Cells Collected4.50 (0 to 30.31)
SecondaryOverall Survival in Patients Undergoing Autologous Stem Cell Transplant
Time frame:
Up to 817 days
Reported as:
Median · Days
Overall Survival in Patients Undergoing Autologous Stem Cell Transplant
DaysAll Patients
Overall Survival in Patients Undergoing Autologous Stem Cell Transplant294 (133 to NA)
SecondaryDisease-free Survival in Patients Undergoing Autologous Stem Cell Transplant
Time frame:
Up to 883 days
Reported as:
Median · Days
Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant
DaysAll Patients
Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant367 (95 to NA)

Adverse events

Collected over 2 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Patients—7/32 (21.9%)31/32 (96.9%)
Most frequent serious events
Most frequent serious events
EventAll Patients
Infection with grade 4 neutrophilsInfections and infestations3/32
Neutropenic feverInfections and infestations1/32
HemorrhageGeneral disorders1/32
Sudden deathGeneral disorders1/32
HemorrhageGastrointestinal disorders1/32
Most frequent other events
Showing 10 of 13
Most frequent other events
EventAll Patients
Neutropenic feverInfections and infestations19/32
Infection/sepsisInfections and infestations16/32
RashSkin and subcutaneous tissue disorders10/32
ThrombocytopeniaBlood and lymphatic system disorders8/32
Non-infectious diarrheaGastrointestinal disorders8/32
Left ventrcular dysfunctionCardiac disorders4/32
HypotensionCardiac disorders4/32
AnemiaGeneral disorders3/32
PneumoniaRespiratory, thoracic and mediastinal disorders3/32
Respiratory failureRespiratory, thoracic and mediastinal disorders2/32

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Patients
Median56 (23 to 83)
Sex: Female, Male
Sex: Female, Male(Participants)All Patients
Female18
Male14
Region of Enrollment
Region of Enrollment(participants)All Patients
United States32
08

Study locations

1 site
  • The University of Chicago
    Chicago, Illinois 60637, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00774046
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Oct 16, 2008
Start date
Dec 2002
Primary completion
Mar 2011
Completion
Mar 2011
Results posted
Jun 24, 2013
Last update
Feb 11, 2014

Study contacts

Lucy Godley, M.D.
principal investigator · University of Chicago

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia→

Other studies from this sponsor

University of Chicago

Start the discussion