Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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)
Secondary ID [1] 0 0
MAXIM-MP-MA-0201
Secondary ID [2] 0 0
CDR0000067196
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

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.)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Newcastle Mater Misericordiae Hospital - Newcastle
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [4] 0 0
St. Vincent's Hospital - Sydney
Recruitment hospital [5] 0 0
NSW Breast Cancer Institute - Westmead
Recruitment hospital [6] 0 0
Wesley Clinic for Hematology/Oncology - Auchenflower
Recruitment hospital [7] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [9] 0 0
Mater Public Hospital - South Brisbane
Recruitment hospital [10] 0 0
Hanson Center for Cancer Research - Adelaide
Recruitment hospital [11] 0 0
Queen Elizabeth Hospital - Adelaide
Recruitment hospital [12] 0 0
Monash Medical Center - East Bentleigh
Recruitment hospital [13] 0 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [14] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [15] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [16] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
NSW 2310 - Newcastle
Recruitment postcode(s) [3] 0 0
2065 - St. Leonards
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4066 - Auchenflower
Recruitment postcode(s) [7] 0 0
4029 - Brisbane
Recruitment postcode(s) [8] 0 0
4102 - Brisbane
Recruitment postcode(s) [9] 0 0
4101 - South Brisbane
Recruitment postcode(s) [10] 0 0
5006 - Adelaide
Recruitment postcode(s) [11] 0 0
5011 - Adelaide
Recruitment postcode(s) [12] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [13] 0 0
8006 - East Melbourne
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
6000 - Perth
Recruitment postcode(s) [16] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Nova Scotia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Canada
State/province [22] 0 0
Saskatchewan
Country [23] 0 0
Denmark
State/province [23] 0 0
Aalborg
Country [24] 0 0
Denmark
State/province [24] 0 0
Odense
Country [25] 0 0
Estonia
State/province [25] 0 0
Tallinn
Country [26] 0 0
Estonia
State/province [26] 0 0
Tartu
Country [27] 0 0
Finland
State/province [27] 0 0
Helsinki
Country [28] 0 0
Finland
State/province [28] 0 0
Kuopio
Country [29] 0 0
Finland
State/province [29] 0 0
Tampere
Country [30] 0 0
Finland
State/province [30] 0 0
Turku
Country [31] 0 0
France
State/province [31] 0 0
Angers
Country [32] 0 0
France
State/province [32] 0 0
Besancon
Country [33] 0 0
France
State/province [33] 0 0
Clichy
Country [34] 0 0
France
State/province [34] 0 0
Le Chesnay
Country [35] 0 0
France
State/province [35] 0 0
Lille
Country [36] 0 0
France
State/province [36] 0 0
Lyon
Country [37] 0 0
France
State/province [37] 0 0
Nantes
Country [38] 0 0
France
State/province [38] 0 0
Rouen
Country [39] 0 0
Germany
State/province [39] 0 0
Augsburg
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Bremen
Country [42] 0 0
Germany
State/province [42] 0 0
Dresden
Country [43] 0 0
Germany
State/province [43] 0 0
Essen
Country [44] 0 0
Germany
State/province [44] 0 0
Frankfurt
Country [45] 0 0
Germany
State/province [45] 0 0
Halle Saale
Country [46] 0 0
Germany
State/province [46] 0 0
Hamburg
Country [47] 0 0
Germany
State/province [47] 0 0
Hannover
Country [48] 0 0
Germany
State/province [48] 0 0
Heidelberg
Country [49] 0 0
Germany
State/province [49] 0 0
Osnabruck
Country [50] 0 0
Germany
State/province [50] 0 0
Rostock
Country [51] 0 0
Germany
State/province [51] 0 0
Saarbrucken
Country [52] 0 0
Germany
State/province [52] 0 0
Tuebingen
Country [53] 0 0
Germany
State/province [53] 0 0
Ulm
Country [54] 0 0
Germany
State/province [54] 0 0
Wurzburg
Country [55] 0 0
Israel
State/province [55] 0 0
Haifa
Country [56] 0 0
Israel
State/province [56] 0 0
Jerusalem
Country [57] 0 0
Israel
State/province [57] 0 0
Petach-Tikva
Country [58] 0 0
Israel
State/province [58] 0 0
Ramat Gan
Country [59] 0 0
Israel
State/province [59] 0 0
Rehovot
Country [60] 0 0
Israel
State/province [60] 0 0
Tel-Aviv
Country [61] 0 0
New Zealand
State/province [61] 0 0
Auckland
Country [62] 0 0
New Zealand
State/province [62] 0 0
Christchurch
Country [63] 0 0
New Zealand
State/province [63] 0 0
Hamilton
Country [64] 0 0
New Zealand
State/province [64] 0 0
Palmerston North
Country [65] 0 0
New Zealand
State/province [65] 0 0
Wellington
Country [66] 0 0
Sweden
State/province [66] 0 0
Eskilstuna
Country [67] 0 0
Sweden
State/province [67] 0 0
Gothenburg (Goteborg)
Country [68] 0 0
Sweden
State/province [68] 0 0
Kalmar
Country [69] 0 0
Sweden
State/province [69] 0 0
Karlstad
Country [70] 0 0
Sweden
State/province [70] 0 0
Linkoping
Country [71] 0 0
Sweden
State/province [71] 0 0
Lund
Country [72] 0 0
Sweden
State/province [72] 0 0
Malmo
Country [73] 0 0
Sweden
State/province [73] 0 0
Orebro
Country [74] 0 0
Sweden
State/province [74] 0 0
Skovde
Country [75] 0 0
Sweden
State/province [75] 0 0
Stockholm
Country [76] 0 0
Sweden
State/province [76] 0 0
Sundsvall
Country [77] 0 0
Sweden
State/province [77] 0 0
Uddevalla
Country [78] 0 0
Sweden
State/province [78] 0 0
Umea
Country [79] 0 0
Sweden
State/province [79] 0 0
Uppsala
Country [80] 0 0
Sweden
State/province [80] 0 0
Vasteras
Country [81] 0 0
United Kingdom
State/province [81] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Maxim Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00003991
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.
Public notes

Contacts
Principal investigator
Name 0 0
Barbara Berryhill
Address 0 0
Maxim Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00003991