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

NCT00774046 | Completed Phase 2 Results DMC

• 1 other identifier: 11884A
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myelodysplastic Syndrome; Acute Myeloid Leukemia

Keywords

Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia; Myelodysplastic syndrome; Acute myeloid leukemia

Outcome Measures

Primary Outcomes (3)

• 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

• Overall Survival

  Up to 2000 days

• 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

Secondary Outcomes (4)

• Feasibility of Stem Cell Collection

  1-5 days from initiation of stem cell collection

• 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

Study Arms (1)

Induction chemotherapy followed by stem cell transplant

EXPERIMENTAL

Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant

Drug: Ara-C; Drug: Mitoxantrone; Drug: Etoposide

Interventions

Ara-C DRUG

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

Induction chemotherapy followed by stem cell transplant

Mitoxantrone DRUG

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

Induction chemotherapy followed by stem cell transplant

Etoposide DRUG

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

Also known as: VP-16

Induction chemotherapy followed by stem cell transplant

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Interventions

Cytarabine; Mitoxantrone; Etoposide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. Lucy A. Godley
• Organization: University of Chicago

lgodley@medicine.bsd.uchicago.edu

773-702-4140

Study Officials

• Lucy Godley, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: December 1, 2002
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 11, 2014
• Results First Posted: June 24, 2013

Record last verified: 2014-01

Locations

US (1)