T-ALL, T-NHL (Lymphoblastic)Phase 2NCT00684619
506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)
A Phase 2 study testing Nelarabine in people with T-ALL, T-NHL (Lymphoblastic), run by Goethe University at 11 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-ALL, T-NHL (Lymphoblastic)
- What is being tested?
- Nelarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 11 sitesGermany
- Study dates
- Jun 2003to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Severe psychiatric illness
- uncontrolled or severe cardiac disease or infection
- active secondary neoplasms - except skin cancer (no melanoma)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
HELIOS Klinikum Berlin-Buch
Berlin, 13125
Universitätsklinik Dresden
Dresden, Saxony, 01307
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147
University Hospital of Frankfurt, Medical Dept. II
Frankfurt am Main, Hesse, 60590
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Klinikum der FSU Jena
Jena, Thuringia, 07747
Universitätsklinikum Kiel
Kiel, Schleswig-Holstein, 24105
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Universitätsklinik Münster
Münster, North Rhine-Westphalia, 48149
Klinikum der Universität Regensburg
Regensburg, Bavaria, 93042
Robert Bosch Krankenhaus
Stuttgart, Baden-Wurttemberg, 70376
About this study
Official title: Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)
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.
- Conditions
- T-ALL, T-NHL (Lymphoblastic)
- Being tested
- Nelarabine
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NelarabineDrug
Also called Compound 506U78, Atriance, Arranon
1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Nelarabine Receives: Drug: Nelarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL
Measured: after 1 cycle and 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startJun 2003
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T-ALL, T-NHL (Lymphoblastic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Goekbuget, Goethe University
- Investigators
- Dieter Hoelzer, MD, PhD, Study chair, University Hospital of Frankfurt, Medical Dept. II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684619
- Sponsor's protocol ID
- LN_GMALLE_2004_55
- Status last verified
- Aug 2022
- First submitted
- 16 May 2008
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21715318
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)
- ClinicalTrials.gov ID
- NCT00684619
- Acronym / sponsor ID
- LN_GMALLE_2004_55
- Conditions
- T-ALL, T-NHL (Lymphoblastic)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: NelarabineNelarabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- T-ALL; T-NHL
- age >= 18 years
- cytological treatment failure / relapse
- molecular treatment failure / relapse
- no promising therapy alternatives with approved medication available
Key exclusion criteria (3 listed)
- Severe psychiatric illness
- uncontrolled or severe cardiac disease or infection
- active secondary neoplasms - except skin cancer (no melanoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NelarabineAlso: Compound 506U78, Atriance, Arranon1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5 | Drug | Arm A |
Primary outcome
Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL
Time frame: after 1 cycle and 2 cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Results publication: PubMed 21715318Gokbuget 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Hoelzer, MD, PhD study chair
University Hospital of Frankfurt, Medical Dept. II
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nelarabine in people with T-ALL, T-NHL (Lymphoblastic), run by Goethe University at 11 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL (time frame: after 1 cycle and 2 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00684619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.