506U78 In Relapsed Or Refractory Acute Lymphoblastic Leuk... | NCT00684619

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

NCT00684619

Sponsor

Goethe University

Status

Completed

Last Update Posted

Aug 18, 2022Actual

Enrollment

120Actual

Phase

Phase 2

Conditions

T-ALL, T-NHL (Lymphoblastic)

Interventions

Nelarabine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2003

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

May 16, 2008

First Submission Date that Met QC Criteria

May 23, 2008

First Posted Date

May 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2022

Last Update Posted Date

Aug 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Experimental	Nelarabine	Drug: Nelarabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nelarabine	Drug	1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5	Arm A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL		after 1 cycle and 2 cycles

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dieter Hoelzer, MD, PhD	University Hospital of Frankfurt, Medical Dept. II	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Robert Bosch Krankenhaus		Stuttgart	Baden-Wurttemberg	70376	Germany
Klinikum der Universität Regensburg

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21715318	Result	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.

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type