NCT00684619

Brief Summary

The purpose of this study is to determine whether Nelarabine is effective in the treatment of patients with T-ALL/NHL in order to achieve a complete remission followed by an early stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_2

Geographic Reach
1 country

11 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

June 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

5.5 years

First QC Date

May 16, 2008

Last Update Submit

August 16, 2022

Conditions

T-ALL, T-NHL (Lymphoblastic)

Outcome Measures

Primary Outcomes (1)

  • Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL

    after 1 cycle and 2 cycles

Study Arms (1)

Arm A

EXPERIMENTAL

Nelarabine

Drug: Nelarabine

Interventions

NelarabineDRUG

1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5

Also known as: Compound 506U78, Atriance, Arranon
Arm A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • T-ALL; T-NHL
  • age \>= 18 years
  • cytological treatment failure / relapse
  • molecular treatment failure / relapse
  • no promising therapy alternatives with approved medication available
  • no CNS-manifestation, requiring intrathecal therapy or CNS-radiation
  • no convulsive disease or neurotoxicity \> grade III in patients history
  • written informed consent
  • no cytostatic therapy in the last 10 days
  • no pregnancy or breastfeeding
  • effective contraception
  • recovery of toxicities of previous chemotherapy - except leukemia- related changes like bone marrow suppression or pathological transaminases in liver manifestation

You may not qualify if:

  • Severe psychiatric illness
  • uncontrolled or severe cardiac disease or infection
  • active secondary neoplasms - except skin cancer (no melanoma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Robert Bosch Krankenhaus

Stuttgart, Baden-Wurttemberg, 70376, Germany

Location

Klinikum der Universität Regensburg

Regensburg, Bavaria, 93042, Germany

Location

University Hospital of Frankfurt, Medical Dept. II

Frankfurt am Main, Hesse, 60590, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitätsklinik Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitätsklinik Dresden

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Universitätsklinikum Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Klinikum der FSU Jena

Jena, Thuringia, 07747, Germany

Location

HELIOS Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Related Publications (1)

  • Gokbuget N, Basara N, Baurmann H, Beck J, Bruggemann M, Diedrich H, Guldenzoph B, Hartung G, Horst HA, Huttmann A, Kobbe G, Naumann R, Ratei R, Reichle A, Serve H, Stelljes M, Viardot A, Wattad M, Hoelzer D. High single-drug activity of nelarabine in relapsed T-lymphoblastic leukemia/lymphoma offers curative option with subsequent stem cell transplantation. Blood. 2011 Sep 29;118(13):3504-11. doi: 10.1182/blood-2011-01-329441. Epub 2011 Jun 28.

    PMID: 21715318RESULT

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

nelarabine

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Dieter Hoelzer, MD, PhD

    University Hospital of Frankfurt, Medical Dept. II

    STUDY CHAIR

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
GMALL Head

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 26, 2008

Study Start

June 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 18, 2022

Record last verified: 2022-08

Locations

DE(11)