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

NCT ID: NCT01513603

Last Updated: 2012-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Burkitts Leukemia/Lymphoma Chronic Myelogenous Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CLAG-M

Group Type EXPERIMENTAL

CLAG-M

Intervention Type DRUG

IV times 5 days

CLAG-M

Intervention Type DRUG

Chemotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CLAG-M

IV times 5 days

Intervention Type DRUG

CLAG-M

Chemotherapy

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Leustatin Ara-C Novantrone Cladribine (Leustatin) Cytarabine (Ara-c) Mitoxantrone (Novantrone)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Relapsed or refractory acute lymphoblastic leukemia,
* Burkitts leukemia/lymphoma,
* Lymphoid blastic CML,
* Lymphoblastic lymphoma.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

New York Medical College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Karen Seiter

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karen Seiter, MD

Role: PRINCIPAL_INVESTIGATOR

New York Medical College

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Westchester Medical Center/New York Medical College

Valhalla, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Karen Seiter, MD

Role: CONTACT

914 493 7514

Nasir Ahmed, MD

Role: CONTACT

914 493 7514

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Karen Seiter, MD

Role: primary

914-493-7514

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

L-10,442

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.