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NCT01513603 Clinical Trial

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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
Phase II Trial of CLAG-M in Relapsed ALL

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01513603
Other study ID # L-10,442
Secondary ID
Status Recruiting
Phase Phase 2
First received January 11, 2012
Last updated January 19, 2012
Start date January 2012
Est. completion date January 2014

Study information
Verified date January 2012
Source New York Medical College
Contact Karen Seiter, MD
Phone 914 493 7514
Email karen_seiter@nymc.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Relapsed or refractory acute lymphoblastic leukemia,

- Burkitts leukemia/lymphoma,

- Lymphoid blastic CML,

- Lymphoblastic lymphoma.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CLAG-M
IV times 5 days
• CLAG-M
Chemotherapy

Locations
Country Name City State
United States Westchester Medical Center/New York Medical College Valhalla New York

Sponsors (1)
Lead Sponsor Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete remission percentage 1 month No
Secondary Survival 2 years No
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