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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00003991
Registration number
NCT00003991
Ethics application status
Date submitted
1/11/1999
Date registered
3/06/2004
Date last updated
6/11/2013
Titles & IDs
Public title
Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia
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Scientific title
Multi-Center, Randomized Open-Label Study to Evaluate the Safety and Efficacy of Immunotherapy With Subcutaneous Maxamine (Histamine Dihydrochloride) Plus Proleukin (Interleukin-2) Versus No Treatment (Standard of Care) in Patients With Acute Myeloid Leukemia in First or Subsequent Complete Remission (CR)
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Secondary ID [1]
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MAXIM-MP-MA-0201
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Secondary ID [2]
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CDR0000067196
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Cytologically confirmed acute myeloid leukemia (AML) in first complete remission (CR) or subsequent CR Less than 5% blasts in normal bone marrow Less than 3 months since last dose of chemotherapy OR Less than 6 months since achieving CR
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 OR Karnofsky 70-100% Life expectancy: Greater than 3 months Hematopoietic: WBC at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: PTT normal Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No class III or IV heart disease No hypotension, severe hypertension, or serious or uncontrolled cardiac dysrhythmia (e.g., ventricular arrhythmias) No acute myocardial infarction within the past 12 months No active uncontrolled angina pectoris No symptomatic arteriosclerotic blood vessel disease Pulmonary: No history of asthma within the past 5 years Other: No other active malignancies except localized basal or squamous cell skin cancer or carcinoma in situ of the cervix HIV negative No prior or active peptic or esophageal ulcer disease No history of hypersensitivity to histamine or histamine products, or severe allergies Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior autologous stem cell transplantation allowed No prior allogeneic stem cell transplantation No other concurrent immunomodulating agents Chemotherapy: See Disease Characteristics Prior induction or consolidation therapy allowed No concurrent chemotherapy Endocrine therapy: At least 24 hours since prior corticosteroids No concurrent steroids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent alternative therapy (e.g., laetrile, Brudzinski's treatment, etc.)
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Blinded (masking used)
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Phase
Phase 3
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/1998
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2011
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Sample size
Target
360
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Liverpool Hospital - Liverpool
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Newcastle Mater Misericordiae Hospital - Newcastle
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Royal North Shore Hospital - St. Leonards
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St. Vincent's Hospital - Sydney
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NSW Breast Cancer Institute - Westmead
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Wesley Clinic for Hematology/Oncology - Auchenflower
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Royal Brisbane Hospital - Brisbane
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Princess Alexandra Hospital - Brisbane
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Mater Public Hospital - South Brisbane
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Hanson Center for Cancer Research - Adelaide
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Queen Elizabeth Hospital - Adelaide
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Monash Medical Center - East Bentleigh
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Peter MacCallum Cancer Institute - East Melbourne
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Royal Perth Hospital - Perth
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Fremantle Hospital - Fremantle
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2170 - Liverpool
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NSW 2310 - Newcastle
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2065 - St. Leonards
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2010 - Sydney
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2145 - Westmead
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4066 - Auchenflower
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4029 - Brisbane
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4102 - Brisbane
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4101 - South Brisbane
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5006 - Adelaide
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5011 - Adelaide
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3165 - East Bentleigh
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8006 - East Melbourne
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3050 - Parkville
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6000 - Perth
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6160 - Fremantle
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Maxim Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myeloid leukemia cells. Histamine dihydrochloride may prolong remission and reduce the risk of relapse in patients with acute myeloid leukemia in remission. PURPOSE: Randomized phase III trial to determine the effectiveness of interleukin-2 plus histamine dihydrochloride in treating patients who have acute myeloid leukemia that is in remission following previous therapy.
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Trial website
https://clinicaltrials.gov/study/NCT00003991
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Trial related presentations / publications
Buyse M, Michiels S, Squifflet P, Lucchesi KJ, Hellstrand K, Brune ML, Castaigne S, Rowe JM. Leukemia-free survival as a surrogate end point for overall survival in the evaluation of maintenance therapy for patients with acute myeloid leukemia in complete remission. Haematologica. 2011 Aug;96(8):1106-12. doi: 10.3324/haematol.2010.039131. Epub 2011 May 5. Buyse M, Squifflet P, Lucchesi KJ, Brune ML, Castaigne S, Rowe JM. Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia. Trials. 2011 Mar 23;12:86. doi: 10.1186/1745-6215-12-86.
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Public notes
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Contacts
Principal investigator
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Barbara Berryhill
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Maxim Pharmaceuticals
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Buyse M, Michiels S, Squifflet P, Lucchesi KJ, Hel...
[
More Details
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Journal
Buyse M, Squifflet P, Lucchesi KJ, Brune ML, Casta...
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More Details
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Results not provided in
https://clinicaltrials.gov/study/NCT00003991
Download to PDF