NCT00003837

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable leukemia

Timeline
Completed

Started Sep 1999

Longer than P75 for not_applicable leukemia

Geographic Reach
1 country

7 active sites

Status
completed

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

September 1, 1999

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

June 20, 2013

Status Verified

December 1, 2005

First QC Date

November 1, 1999

Last Update Submit

June 18, 2013

Conditions

LeukemiaLymphoma

Keywords

recurrent adult acute lymphoblastic leukemiaT-cell adult acute lymphoblastic leukemiarecurrent adult lymphoblastic lymphoma

Outcome Measures

Primary Outcomes (1)

  • Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority

Secondary Outcomes (2)

  • Toxicity

  • Antitumor efficacy as defined by the rate of complete hematologic responses

Interventions

nelarabineDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma * Tumor cells should exhibit phenotypic characteristics of these diseases * No CNS involvement requiring intrathecal or craniospinal radiotherapy * Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-3 OR * Karnofsky 40-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 50 mL/min Other: * No neuropathy grade 2 or higher * No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy * No active seizure disorder * No active infection * No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior bone marrow transplantation allowed * No concurrent allogeneic bone marrow transplantation Chemotherapy: * At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered * No prior 506U78 Endocrine therapy: * No concurrent systemic steroid therapy Radiotherapy: * See Disease Characteristics * Prior radiotherapy allowed Surgery: * Not specified Other: * No other concurrent investigational therapy * No concurrent treatment for seizures

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612, United States

Location

NCI - Pharmaceutical Management Branch

Bethesda, Maryland, 20892, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5047, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

nelarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Lymphoid

Study Officials

  • Anthony J. Murgo, MD

    NCI - Investigational Drug Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1999

Study Completion

November 1, 2007

Last Updated

June 20, 2013

Record last verified: 2005-12

Locations

US(7)