Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by St. Jude Children's Research Hospital
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00703820
First received: June 20, 2008
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to assess the feasibility and efficacy of a novel form of therapy—haploidentical NK cell transplantation—in patients with standard-risk AML. In addition, we will investigate the efficacy of clofarabine + cytarabine (Clo/AraC) in newly diagnosed patients with AML and attempt to optimize outcome through the use of MRD-adapted therapy and further improvements in supportive care.


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: Cytarabine
Drug: Daunorubicin
Drug: Etoposide
Drug: Clofarabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AML08: A Phase II Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Phase II Study Of Natural Killer Cell Transplantation In Patients With Newly Diagnosed Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • To compare the immunologic complete response rate after one course of therapy in patients who receive cytarabine + daunorubicin + etoposide (ADE) with that in patients who receive clofarabine + cytarabine (Clo/AraC) [ Time Frame: Day 22 MRD measurement ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Event-free survival of standard risk patients who receive chemotherapy alone. [ Time Frame: 3 years after completion of therapy ] [ Designated as safety issue: No ]
  • Event-free survival of standard risk patients who receive chemotherapy followed by natural killer cell transplantation. [ Time Frame: 3 years after completion of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: August 2008
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Cytarabine + Daunorubicin + Etoposide
Drug: Cytarabine
See Detailed Description
Drug: Daunorubicin
See Detailed Description
Drug: Etoposide
See Detailed Description
Active Comparator: 2
Clofarabine + Cytarabine
Drug: Cytarabine
See Detailed Description
Drug: Clofarabine
See Detailed Description

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age less than or equal to 21 years at time of study entry.
  • No prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m2 per day for one week or less ) for hyperleukocytosis.
  • Written informed consent according to institutional guidelines
  • Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
  • Male and female participants must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

Exclusion Criteria:

  • Down syndrome
  • Acute Promyelocytic Leukemia (APL)
  • Juvenile Myelomonocytic Leukemia (JMML)
  • Fanconi anemia (FA)
  • Kostmann syndrome
  • Shwachman syndrome
  • Other bone marrow failure syndromes
  • Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
  • Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of IT therapy, hydroxyurea, or low-dose cytarabine as stated above. The patient must have recovered from all acute toxicities from any previous therapy.
  • Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  • Pregnant or lactating patients.
  • Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703820

Contacts
Contact: Jeffrey Rubnitz, MD 1-866-278-5833 info@stjude.org

Locations
United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Gary Dahl, MD         
Contact: Norman Lacayo, MD         
Principal Investigator: Gary Dahl, MD         
Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
Contact: Deborah E. Schiff, MD         
Principal Investigator: Deborah E. Schiff, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: John Cunningham, MD         
Principal Investigator: John Cunningham, MD         
United States, Massachusetts
Dana Farber Cancer Institute and Children's Hospital Recruiting
Boston, Massachusetts, United States, 02215-5450
Contact: Barbara Degar, MD         
Principal Investigator: Barbara Degar, MD         
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Jeffrey Taub, MD         
Principal Investigator: Jeffrey Taub, MD         
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Jeffrey Rubnitz, MD    866-278-5833    info@stjude.org   
Principal Investigator: Jeffrey Rubnitz, MD         
United States, Texas
Cook's Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Paul Bowman, MD         
Contact: Ken Heym, MD         
Principal Investigator: Paul Bowman, MD         
Singapore
National University Health System Recruiting
Singapore, Singapore, 119228
Contact: Allen Eng-Juh Yeoh, MD    (65) 6772 4420    Paev15@nus.edu.sg   
Principal Investigator: Allen Eng-Juh Yeoh, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Jeffrey Rubnitz, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00703820     History of Changes
Other Study ID Numbers: AML08, 5R01CA138744, 1R01CA115422
Study First Received: June 20, 2008
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Clofarabine
Cytarabine
Etoposide
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on October 19, 2014