NCT01513603

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

2 years

First QC Date

January 11, 2012

Last Update Submit

January 19, 2012

Conditions

Acute Lymphoblastic LeukemiaLymphoblastic LymphomaBurkitts Leukemia/LymphomaChronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (1)

  • Complete remission percentage

    1 month

Secondary Outcomes (1)

  • Survival

    2 years

Study Arms (1)

CLAG-M

EXPERIMENTAL
Drug: CLAG-M

Interventions

CLAG-MDRUG

IV times 5 days

Also known as: Leustatin, Ara-C, Novantrone
CLAG-M

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westchester Medical Center/New York Medical College

Valhalla, New York, 10595, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphomaLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

CladribineCytarabineMitoxantrone

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-ChloroadenosineAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxyadenosinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingArabinonucleosidesAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic Compounds

Study Officials

  • Karen Seiter, MD

    New York Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Seiter, MD

CONTACT

914 493 7514karen_seiter@nymc.edu

Nasir Ahmed, MD

CONTACT

914 493 7514nasir_ahmed@nymc.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 20, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

US(1)