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

Primary Purpose

Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitts Leukemia/Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CLAG-M

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

Westchester Medical Center/New York Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CLAG-M

Arm Description

Outcomes

Primary Outcome Measures

Complete remission percentage

Secondary Outcome Measures

Survival

Full Information

NCT ID

NCT01513603

First Posted

January 11, 2012

Last Updated

January 19, 2012

Sponsor

New York Medical College

1. Study Identification

Unique Protocol Identification Number

NCT01513603

Brief Title

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

Official Title

Phase II Trial of CLAG-M in Relapsed ALL

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

January 2014 (Anticipated)

Study Completion Date

January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York Medical College

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CLAG-M

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CLAG-M

Other Intervention Name(s)

Leustatin, Ara-C, Novantrone

Intervention Description

IV times 5 days

Intervention Type

Drug

Intervention Name(s)

CLAG-M

Other Intervention Name(s)

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

Intervention Description

Chemotherapy

Primary Outcome Measure Information:

Title

Complete remission percentage

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Survival

Time Frame

2 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Relapsed or refractory acute lymphoblastic leukemia, Burkitts leukemia/lymphoma, Lymphoid blastic CML, Lymphoblastic lymphoma.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karen Seiter, MD

Phone

914 493 7514

karen_seiter@nymc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Nasir Ahmed, MD

Phone

914 493 7514

nasir_ahmed@nymc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Seiter, MD

Organizational Affiliation

New York Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Westchester Medical Center/New York Medical College

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karen Seiter, MD

Phone

914-493-7514

karen_seiter@nymc.edu

First Name & Middle Initial & Last Name & Degree

Karen Seiter, MD

First Name & Middle Initial & Last Name & Degree

Delong Liu, MD, PhD

First Name & Middle Initial & Last Name & Degree

Claudio Sandoval, MD

12. IPD Sharing Statement

Learn more about this trial

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

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