Trial of Cladribine, Cytarabine, Mitoxantrone, Filgrastim (CLAG-M) in Relapsed Acute Lymphoblastic Leukemia
Sponsor
New York Medical College (Other)
Overall Status
Unknown status
CT.gov ID
NCT01513603
Collaborator
(none)
50
1
1
24
2.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Study Type:
Interventional
Anticipated Enrollment
:
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of CLAG-M in Relapsed ALL
Study Start Date
:
Jan 1, 2012
Anticipated Primary Completion Date
:
Jan 1, 2014
Anticipated Study Completion Date
:
Jan 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CLAG-M
|
Drug: CLAG-M
IV times 5 days
Other Names:
Drug: CLAG-M
Chemotherapy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Complete remission percentage [1 month]
Secondary Outcome Measures
- Survival [2 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Relapsed or refractory acute lymphoblastic leukemia,
-
Burkitts leukemia/lymphoma,
-
Lymphoid blastic CML,
-
Lymphoblastic lymphoma.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Westchester Medical Center/New York Medical College | Valhalla | New York | United States | 10595 |
Sponsors and Collaborators
- New York Medical College
Investigators
- Principal Investigator: Karen Seiter, MD, New York Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Karen Seiter,
Professor of Medicine,
New York Medical College
ClinicalTrials.gov Identifier:
NCT01513603
Other Study ID Numbers:
- L-10,442
First Posted:
Jan 20, 2012
Last Update Posted:
Jan 20, 2012
Last Verified:
Jan 1, 2012