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

New York Medical College

Status and phase: Unknown; Phase 2

Conditions: Lymphoblastic Lymphoma; Chronic Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Burkitts Leukemia/Lymphoma

Treatments: Drug: CLAG-M

Study type: Interventional

Funder types: Other

Identifiers

NCT01513603

L-10,442

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

CLAG-M

Experimental group

Treatment:

Drug: CLAG-M

Drug: CLAG-M