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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01513603
Recruitment Status : Unknown
Verified January 2012 by Karen Seiter, New York Medical College.
Recruitment status was:  Recruiting
First Posted : January 20, 2012
Last Update Posted : January 20, 2012
Information provided by (Responsible Party):
Karen Seiter, New York Medical College

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Burkitts Leukemia/Lymphoma Chronic Myelogenous Leukemia Drug: CLAG-M Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of CLAG-M in Relapsed ALL
Study Start Date : January 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: CLAG-M Drug: CLAG-M
IV times 5 days
Other Names:
  • Leustatin
  • Ara-C
  • Novantrone

Drug: CLAG-M
Other Names:
  • Cladribine (Leustatin)
  • Cytarabine (Ara-c)
  • Mitoxantrone (Novantrone)

Primary Outcome Measures :
  1. Complete remission percentage [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Relapsed or refractory acute lymphoblastic leukemia,
  • Burkitts leukemia/lymphoma,
  • Lymphoid blastic CML,
  • Lymphoblastic lymphoma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01513603

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Contact: Karen Seiter, MD 914 493 7514
Contact: Nasir Ahmed, MD 914 493 7514

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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   
Principal Investigator: Karen Seiter, MD         
Sub-Investigator: Delong Liu, MD, PhD         
Sub-Investigator: Claudio Sandoval, MD         
Sponsors and Collaborators
New York Medical College
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Principal Investigator: Karen Seiter, MD New York Medical College
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Responsible Party: Karen Seiter, Professor of Medicine, New York Medical College Identifier: NCT01513603    
Other Study ID Numbers: L-10,442
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Burkitt Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action