Text Size

Trial of Cladribine, Cytarabine, Mitoxantrone, Filgrastim (CLAG-M) in Relapsed Acute Lymphoblastic Leukemia

This study is currently recruiting participants.
Verified January 2012 by New York Medical College
Sponsor:
Information provided by (Responsible Party):
Karen Seiter, New York Medical College
ClinicalTrials.gov Identifier:
NCT01513603
First received: January 11, 2012
Last updated: January 19, 2012
Last verified: January 2012
History of Changes
  Purpose

CLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the agents is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will determine the efficacy of the regimen in patients with relapsed ALL.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Burkitts Leukemia/Lymphoma
Chronic Myelogenous Leukemia
 Drug: CLAG-M
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of CLAG-M in Relapsed ALL

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York Medical College:

Primary Outcome Measures:
  • Complete remission percentage [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLAG-M Drug: CLAG-M
IV times 5 days
Other Names:
  • Leustatin
  • Ara-C
  • Novantrone
Drug: CLAG-M
Chemotherapy
Other Names:
  • Cladribine (Leustatin)
  • Cytarabine (Ara-c)
  • Mitoxantrone (Novantrone)

Detailed Description:

Patients will receive standard dose CLAG-M (cladribine, cytarabine, mitoxantrone, filgrastim). Standard support care will be given. Efficacy will be assessed through bone marrow examinations and blood tests.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed or refractory acute lymphoblastic leukemia,
  • Burkitts leukemia/lymphoma,
  • Lymphoid blastic CML,
  • Lymphoblastic lymphoma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513603

Contacts
Contact: Karen Seiter, MD 914 493 7514 karen_seiter@nymc.edu
Contact: Nasir Ahmed, MD 914 493 7514 nasir_ahmed@nymc.edu

Locations
United States, New York
Westchester Medical Center/New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Karen Seiter, MD     914-493-7514     karen_seiter@nymc.edu    
Principal Investigator: Karen Seiter, MD            
Sub-Investigator: Delong Liu, MD, PhD            
Sub-Investigator: Claudio Sandoval, MD            
Sponsors and Collaborators
New York Medical College
Investigators
Principal Investigator: Karen Seiter, MD New York Medical College
  More Information

No publications provided

Responsible Party: Karen Seiter, Professor of Medicine, New York Medical College
ClinicalTrials.gov Identifier: NCT01513603     History of Changes
Other Study ID Numbers: L-10,442
Study First Received: January 11, 2012
Last Updated: January 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Epstein-Barr Virus Infections
Burkitt Lymphoma
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neoplasms by Histologic Type
Neoplasms
 Lymphoma, B-Cell
Neoplasms, Experimental
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cytarabine
Cladribine
Mitoxantrone
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013