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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
National Cancer Institute (NCI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00703820
First received: June 20, 2008
Last updated: April 12, 2017
Last verified: April 2017
  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 Device: CliniMACS Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • Event-free survival of standard risk patients who receive chemotherapy alone. [ Time Frame: 3 years after completion of therapy ]
  • Event-free survival of standard risk patients who receive chemotherapy followed by natural killer cell transplantation. [ Time Frame: 3 years after completion of therapy ]

Enrollment: 324
Actual Study Start Date: August 4, 2008
Estimated Study Completion Date: June 30, 2020
Primary Completion Date: March 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ADE

Cytarabine + Daunorubicin + Etoposide

NK cells for infusion are prepared using the CliniMACS System.

Drug: Cytarabine
See Detailed Description
Other Names:
  • Ara-C
  • Cytosar-U®
Drug: Daunorubicin
See Detailed Description
Other Names:
  • Daunomycin
  • Cerubidine®
Drug: Etoposide
See Detailed Description
Other Names:
  • VP-16
  • Vepesid®
Device: CliniMACS
The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
Other Name: Cell Selection System
Active Comparator: Clo/AraC

Clofarabine + Cytarabine

NK cells for infusion are prepared using the CliniMACS System.

Drug: Cytarabine
See Detailed Description
Other Names:
  • Ara-C
  • Cytosar-U®
Drug: Clofarabine
See Detailed Description
Other Names:
  • Clolar^TM
  • Clofarex
Device: CliniMACS
The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
Other Name: Cell Selection System

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Locations
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana Farber Cancer Institute and Children's Hospital
Boston, Massachusetts, United States, 02215-5450
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Cook's Children's Medical Center
Fort Worth, Texas, United States, 76104
Singapore
National University Health System
Singapore, Singapore, 119228
Sponsors and Collaborators
St. Jude Children's Research Hospital
Genzyme, a Sanofi Company
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeffrey Rubnitz, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00703820     History of Changes
Other Study ID Numbers: AML08
R01CA138744 ( US NIH Grant/Contract Award Number )
R01CA115422 ( US NIH Grant/Contract Award Number )
R01CA132946 ( US NIH Grant/Contract Award Number )
NCI-2011-03659 ( Registry Identifier: NCI Clinical Trial Registration Program )
Study First Received: June 20, 2008
Last Updated: April 12, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

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

ClinicalTrials.gov processed this record on June 26, 2017