LeukemiaPhase 2NCT00003148
Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
A Phase 2 study testing aldesleukin in people with Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 6 countries.
Trial summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myelogenous leukemia cells. PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with acute myelogenous leukemia that has relapsed following previous treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Leukemia
- What is being tested?
- aldesleukin
- How many people
- 86 participants
- Where
- 10 sitesin 6 countries
- Study dates
- Oct 1997to Apr 2001
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS: Histologically confirmed acute myeloid leukemia (AML) that has relapsed after prior treatment(s) Slowly progressing disease as defined by bone marrow blasts of greater than 5% and less than 30% confirmed by at least 2 marrow aspirates taken 2 weeks apart Must be in either: First relapse after autologous bone marrow or peripheral blood stem cell transplantation OR First or subsequent relapse either refractory to or not eligible for further conventional treatment regimens
PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Bilirubin less than 2 times normal Renal: Creatinine less than 2 times normal Cardiovascular: Ejection fraction normal Pulmonary: PLCO diffusion greater than 60% Other: No active uncontrolled infections No other progressive malignant disease Not a poor medical risk because of nonmalignant systemic disease
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent steroids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent indomethacin No other concurrent anticancer or investigational therapy
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Belgium2 sites
Institut Jules Bordet
Brussels, 1000
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
France2 sites
Hotel Dieu de Paris
Paris, 75181
Institut Gustave Roussy
Villejuif, F-94805
Italy2 sites
Ospedale San Eugenio
Rome, 00144
Azienda Policlinico Umberto Primo
Rome, 00161
Netherlands2 sites
Leiden University Medical Center
Leiden, 2300 CA
University Medical Center Nijmegen
Nijmegen, NL-6252 HB
About this study
Official title: Phase II Study of the Efficacy of rH Interleukin-2 in Patients With Slowly Progressing Acute Myelogenous Leukemia (AML) and With Limited Bone Marrow Blastosis After Autologous Stem Cell Transplantation or Chemotherapy
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myelogenous leukemia cells.
PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with acute myelogenous leukemia that has relapsed following previous treatment.
Read the detailed description
OBJECTIVES: I. Assess the therapeutic activity of interleukin-2 (IL-2) in patients with slowly progressing acute myeloid leukemia with limited bone marrow blastosis either in first relapse after autologous bone marrow or peripheral blood stem cell transplantation, or with more advanced disease (i.e., refractory to chemotherapy regimens). II. Characterize the acute side effects of IL-2 in these patients.
OUTLINE: This is an open label, nonrandomized, multicenter study. Patients are stratified into two categories of prior failed treatments (first relapse after autologous bone marrow or peripheral blood stem cell transplantation vs first or subsequent relapse either refractory to or not eligible for further conventional treatment). Interleukin-2 (IL-2) is administered as a continuous intravenous infusion on 5 consecutive days at daily escalating doses for the first cycle. When the individual maximum tolerated dose (MTD) has been determined, 3 more cycles are given at the MTD. There are 3 days of rest between each treatment cycle. After the induction phase, maintenance cycles of IL-2 are administered starting 4 weeks after the last induction treatment. Maintenance cycles of IL-2 are administered subcutaneously on 5 consecutive days every 4 weeks for 2 years, and subsequently every other month for a maximum of 3 years. Treatment continues until disease progression or unacceptable toxicity for a maximum of 5 years. Patients are followed every 4 weeks during the first 2 years, then every 8 weeks during the next 3 years or until documented progression, and then every 3 months until death.
PROJECTED ACCRUAL: A maximum of 86 (57 transplanted; 29 patients nontransplanted) patients will be accrued into this study within 2 years.
- Conditions
- Leukemia
- Being tested
- aldesleukin
- Keywords
- recurrent adult acute myeloid leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2004 (estimated)
- Study startOct 1997
- Primary completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- 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
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Roel Willemze, MD, PhD, Study chair, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003148
- Sponsor's protocol ID
- EORTC-06964
- Other IDs
- EORTC-06964
- Status last verified
- Jun 2012
- First submitted
- 1 Nov 1999
- Last updated
- 2 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Efficacy of rH Interleukin-2 in Patients With Slowly Progressing Acute Myelogenous Leukemia (AML) and With Limited Bone Marrow Blastosis After Autologous Stem Cell Transplantation or Chemotherapy
- ClinicalTrials.gov ID
- NCT00003148
- Acronym / sponsor ID
- EORTC-06964
- Conditions
- Leukemia
- Keywords
- recurrent adult acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Oct 1997
- Primary completion
- Apr 2001 (actual)
- First posted
- 23 Apr 2004 (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.
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myelogenous leukemia cells.
PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with acute myelogenous leukemia that has relapsed following previous treatment.
Detailed description
OBJECTIVES: I. Assess the therapeutic activity of interleukin-2 (IL-2) in patients with slowly progressing acute myeloid leukemia with limited bone marrow blastosis either in first relapse after autologous bone marrow or peripheral blood stem cell transplantation, or with more advanced disease (i.e., refractory to chemotherapy regimens). II. Characterize the acute side effects of IL-2 in these patients.
OUTLINE: This is an open label, nonrandomized, multicenter study. Patients are stratified into two categories of prior failed treatments (first relapse after autologous bone marrow or peripheral blood stem cell transplantation vs first or subsequent relapse either refractory to or not eligible for further conventional treatment). Interleukin-2 (IL-2) is administered as a continuous intravenous infusion on 5 consecutive days at daily escalating doses for the first cycle. When the individual maximum tolerated dose (MTD) has been determined, 3 more cycles are given at the MTD. There are 3 days of rest between each treatment cycle. After the induction phase, maintenance cycles of IL-2 are administered starting 4 weeks after the last induction treatment. Maintenance cycles of IL-2 are administered subcutaneously on 5 consecutive days every 4 weeks for 2 years, and subsequently every other month for a maximum of 3 years. Treatment continues until disease progression or unacceptable toxicity for a maximum of 5 years. Patients are followed every 4 weeks during the first 2 years, then every 8 weeks during the next 3 years or until documented progression, and then every 3 months until death.
PROJECTED ACCRUAL: A maximum of 86 (57 transplanted; 29 patients nontransplanted) patients will be accrued into this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| aldesleukin | Biological | – |
Primary outcome
Not reported in the source record.
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 2 Jul 2012.
Related trials for Leukemia
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
RecruitingPhase 1/2
Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia
T-cell Prolymphocytic Leukemia, Refractory T-Cell Prolymphocytic 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.
Roel Willemze, MD, PhD study chair
Leiden University Medical Center
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aldesleukin in people with Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium, France, Italy, Netherlands, Austria and 1 more country. 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.
Where can I read the original study information?
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 2 Jul 2012.