Leukemia, Lymphocytic, AcutePhase 3NCT00483132
Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III
A Phase 3 study testing interferon alpha 2a in people with Leukemia, Lymphocytic, Acute, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy. High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma (LBL). Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Leukemia, Lymphocytic, Acute
- What is being tested?
- interferon alpha 2a
- How many people
- 232 participants
- Where
- 1 siteFrance
- Study dates
- Sep 1994to Apr 2002
- Phase
- Phase 3
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ALL high risk or low risk or lymphoblastic lymphoma
- age 15-55 years old
- informed consent signed
Who cannot join
- patients previously treated with a chemotherapy or alpha-interferon
- ALL 3 (burkitt like)
Trial locations and contacts
1 site in 1 country.
About this study
Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy.
High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma (LBL).
Read the detailed description
Comparison between two autograf therapeutic strategies in high risk patients Ramdomised comparison between maintenance treatment with or not interferon alpha 2 a
- Conditions
- Leukemia, Lymphocytic, Acute
- Being tested
- interferon alpha 2a
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon alpha 2aDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: time to death
Secondary outcomes (1)
Efficacy of study treatments
Measured: time to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startSep 1994
- Study completionApr 2002
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 Leukemia, Lymphocytic, AcuteStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Investigators
- Norbert IFRAH, Pr, Principal investigator, French Innovative Leukemia OrganisationNoël MILPIED, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483132
- Sponsor's protocol ID
- GOELAL02
- Status last verified
- Jun 2007
- First submitted
- 5 Jun 2007
- Last updated
- 6 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hunault M, Harousseau JL, Delain M, Truchan-Graczyk M, Cahn JY, Witz F, Lamy T, Pignon B, Jouet JP, Garidi R, Caillot D, Berthou C, Guyotat D, Sadoun A, Sotto JJ, Lioure B, Casassus P, Solal-Celigny P, Stalnikiewicz L, Audhuy B, Blanchet O, Baranger L, Bene MC, Ifrah N; GOELAMS (Groupe Ouest-Est des Leucemies Airgues et Maladies du Sang) Group. Better outcome of adult acute lymphoblastic leukemia after early genoidentical allogeneic bone marrow transplantation (BMT) than after late high-dose therapy and autologous BMT: a GOELAMS trial. Blood. 2004 Nov 15;104(10):3028-37. doi: 10.1182/blood-2003-10-3560. Epub 2004 Jul 15.
PubMed 15256423
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III
- ClinicalTrials.gov ID
- NCT00483132
- Acronym / sponsor ID
- GOELAL02
- Conditions
- Leukemia, Lymphocytic, Acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Study start
- Sep 1994
- Study completion
- Apr 2002 (actual)
- First posted
- 6 Jun 2007 (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.
Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy.
High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma (LBL).
Detailed description
Comparison between two autograf therapeutic strategies in high risk patients Ramdomised comparison between maintenance treatment with or not interferon alpha 2 a
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ALL high risk or low risk or lymphoblastic lymphoma
- age 15-55 years old
- informed consent signed
Key exclusion criteria (2 listed)
- patients previously treated with a chemotherapy or alpha-interferon
- ALL 3 (burkitt like)
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 |
|---|---|---|
| interferon alpha 2a | Drug | – |
Primary outcome
overall survival
Time frame: time to death
1 secondary outcome
Efficacy of study treatments
Time frame: time to end of treatment
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 6 Jun 2007.
- Results publication: PubMed 15256423Hunault M, Harousseau JL, Delain M, Truchan-Graczyk M, Cahn JY, Witz F, Lamy T, Pignon B, Jouet JP, Garidi R, Caillot D, Berthou C, Guyotat D, Sadoun A, Sotto JJ, Lioure B, Casassus P, Solal-Celigny P, Stalnikiewicz L, Audhuy B, Blanchet O, Baranger L, Bene MC, Ifrah N; GOELAMS (Groupe Ouest-Est des Leucemies Airgues et Maladies du Sang) Group. Better outcome of adult acute lymphoblastic leukemia after early genoidentical allogeneic bone marrow transplantation (BMT) than after late high-dose therapy and autologous BMT: a GOELAMS trial. Blood. 2004 Nov 15;104(10):3028-37. doi: 10.1182/blood-2003-10-3560. Epub 2004 Jul 15.
Related trials for Leukemia, Lymphocytic, Acute
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Norbert IFRAH, Pr principal investigator
French Innovative Leukemia Organisation
Noël MILPIED principal investigator
French Innovative Leukemia Organisation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing interferon alpha 2a in people with Leukemia, Lymphocytic, Acute, run by French Innovative Leukemia Organisation at 1 site in France.
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 3 inclusion and 2 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 6 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
overall survival (time frame: time to death). 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 NCT00483132, 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 6 Jun 2007.