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

Phase 2

• Conditions: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Chronic Myelogenous Leukemia; Burkitts Leukemia/Lymphoma
• Interventions: Drug: CLAG-M

• Registration Number: NCT01513603
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-19
• Last Update Submitted: 2012-01-19
• Study First Posted: 2012-01-20
• Last Update Posted: 2012-01-20
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLAG-M	CLAG-M	-

Primary Outcome Measures

Name	Time	Method
Complete remission percentage	1 month

Secondary Outcome Measures

Name	Time	Method
Survival	2 years

Trial Locations

Locations (1)

Westchester Medical Center/New York Medical College; 🇺🇸 Valhalla, New York, United States