search
Back to results

506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)

Primary Purpose

T-ALL, T-NHL (Lymphoblastic)

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Nelarabine
Sponsored by
Goethe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-ALL, T-NHL (Lymphoblastic)

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Robert Bosch Krankenhaus
  • Klinikum der Universität Regensburg
  • University Hospital of Frankfurt, Medical Dept. II
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Essen
  • Universitätsklinik Münster
  • Universitätsklinik Dresden
  • Universitätsklinikum Leipzig
  • Universitätsklinikum Kiel
  • Klinikum der FSU Jena
  • HELIOS Klinikum Berlin-Buch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

Nelarabine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 16, 2008
Last Updated
August 16, 2022
Sponsor
Goethe University
search

1. Study Identification

Unique Protocol Identification Number
NCT00684619
Brief Title
506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)
Official Title
Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-ALL, T-NHL (Lymphoblastic)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Nelarabine
Intervention Type
Drug
Intervention Name(s)
Nelarabine
Other Intervention Name(s)
Compound 506U78, Atriance, Arranon
Intervention Description
1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5
Primary Outcome Measure Information:
Title
Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL
Time Frame
after 1 cycle and 2 cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Severe psychiatric illness uncontrolled or severe cardiac disease or infection active secondary neoplasms - except skin cancer (no melanoma)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Hoelzer, MD, PhD
Organizational Affiliation
University Hospital of Frankfurt, Medical Dept. II
Official's Role
Study Chair
Facility Information:
Facility Name
Robert Bosch Krankenhaus
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70376
Country
Germany
Facility Name
Klinikum der Universität Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93042
Country
Germany
Facility Name
University Hospital of Frankfurt, Medical Dept. II
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinik Münster
City
Münster
State/Province
NRW
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinik Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum der FSU Jena
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
HELIOS Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21715318
Citation
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.
Results Reference
result

Learn more about this trial

506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)

We'll reach out to this number within 24 hrs