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Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
aldesleukin
histamine dihydrochloride
Sponsored by
Maxim Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring adult acute myeloid leukemia in remission

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • University of Alabama Comprehensive Cancer Center
  • Arizona Cancer Center
  • Scripps Clinic
  • Cedars-Sinai Medical Center
  • Kaiser Permanente-Southern California Permanente Medical Group
  • Sidney Kimmel Cancer Center
  • Pacific Hematology/Oncology
  • Bethesda Bone Marrow Stem Cell Transplant Institute
  • University of Florida Health Science Center - Jacksonville
  • Emory University Hospital - Atlanta
  • University of Kansas Medical Center
  • Oncology and Hematology Associates
  • Maine Center for Cancer Medicine and Blood Disorders
  • Henry Ford Hospital
  • Providence Hospital Cancer Center
  • Washington University School of Medicine
  • Nevada Cancer Center
  • Nevada Medical Group-Internal Medicine
  • University of New Mexico Cancer Research & Treatment Center
  • Our Lady of Mercy Medical Center
  • New York Presbyterian Hospital - Cornell Campus
  • University of Rochester Cancer Center
  • New York Medical College
  • Ireland Cancer Center
  • University of Oklahoma Health Sciences Center
  • University of Pennsylvania Cancer Center
  • Western Pennsylvania Hospital
  • West Clinic, P.C.
  • Boston Cancer Group
  • Baylor University Medical Center
  • Cancer Care Institute of South Texas
  • South Texas Cancer Institute
  • Liverpool Hospital
  • Newcastle Mater Misericordiae Hospital
  • Royal North Shore Hospital
  • St. Vincent's Hospital
  • NSW Breast Cancer Institute
  • Wesley Clinic for Hematology/Oncology
  • Royal Brisbane Hospital
  • Princess Alexandra Hospital
  • Mater Public Hospital
  • Hanson Center for Cancer Research
  • Queen Elizabeth Hospital
  • Monash Medical Center
  • Peter MacCallum Cancer Institute
  • Royal Melbourne Hospital
  • Royal Perth Hospital
  • Fremantle Hospital
  • Vancouver General Hospital
  • Queen Elizabeth II Health Science Center
  • London Health Sciences Centre
  • Ottawa Regional Cancer Center - General Division
  • Seaforth Medical Centre
  • Hopital Du Sacre-Coeur de Montreal
  • Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
  • Royal University Hospital
  • Aalborg Hospital
  • Odense University Hospital
  • Tallinn Central Hospital
  • University of Tartu
  • Helsinki University Central Hospital
  • Kuopio University Hospital
  • Tampere University Hospital
  • Turku University Central Hospital
  • Centre Hospitalier Regional et Universitaire d'Angers
  • CHR de Besancon - Hopital Jean Minjoz
  • Hopital Beaujon
  • Hopital Andre Mignot
  • Centre Hospitalier Regional de Lille
  • Hopital Edouard Herriot
  • CHR Hotel Dieu
  • Centre Henri Becquerel
  • Zentralklinikum Augsburg
  • Universitaetsklinikum Charite
  • Evang. Diakonissenanstalt
  • Medizinische Klinik I
  • Universitaetsklinik und Strahlenklinik - Essen
  • Klinikum der J.W. Goethe Universitaet
  • Martin Luther Universitaet
  • Universitats-Krankenhaus Eppendorf
  • Medizinische Hochschule Hannover
  • Medizinische Klinik und Poliklinik
  • Staedtische Kliniken Osnabruek
  • Universitat Rostock
  • Caritasklinik St. Theresa
  • Universitaetsklinikum Tuebingen
  • Klinikum der Universitaet Ulm
  • Medizinische Poliklinik der Universitat
  • Rambam Medical Center
  • Hadassah University Hospital
  • Rabin Medical Center
  • Sheba Medical Center
  • Kaplan Hospital
  • Tel-Aviv Medical Center-Ichilov Hospital
  • University of Auckland School of Medicine
  • Canterbury Health Laboratories
  • Waikato Hospital
  • Palmerston North Hospital
  • Wellington Hospital
  • County Hospital (Malar Hospital)
  • Sahlgrenska University Hospital
  • County Hospital/Kalmar
  • Central Hospital
  • University Hospital of Linkoping
  • Lund University Hospital
  • Malmo University Hospital
  • Regional Hospital
  • County Hospital (Karnsjukhuset)
  • Huddinge Hospital
  • Karolinska Hospital
  • County Hospital/Sundsvall
  • County Hospital/Uddevalla
  • Umea Universitet
  • University Hospital - Uppsala
  • County Hospital/Vasteras
  • Birmingham Heartlands and Solihull NHS Trust (Teaching)
  • Leeds Teaching Hospital Trust
  • Manchester Royal Infirmary

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
November 5, 2013
Sponsor
Maxim Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00003991
Brief Title
Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maxim Pharmaceuticals

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: I. Compare the efficacy of interleukin-2 plus histamine dihydrochloride (Maxamine) vs no further therapy in prolonging the leukemia free survival in patients with acute myeloid leukemia in first or subsequent complete remission (CR) following consolidation therapy. II. Compare the relapse rate, overall survival, and quality of life in this patient population treated with interleukin-2 plus Maxamine vs no further therapy. III. Compare the remission inversion rate in patients in subsequent CR with this treatment regimen vs no further therapy. OUTLINE: This is a randomized, open label, parallel, multicenter study. Patients are stratified according to complete remission (first vs subsequent). Patients are randomized to one of two treatment arms. Arm I: Following consolidation chemotherapy or autologous stem cell transplantation, patients receive interleukin-2 subcutaneously followed by histamine dihydrochloride subcutaneously over 5-7 minutes twice daily on days 1-21. Treatment repeats every 6 weeks for 3 courses and then every 9 weeks for 7 courses in the absence of disease relapse or unacceptable toxicity. Arm II: Patients receive no further therapy following consolidation chemotherapy or autologous stem cell transplantation. Quality of life is assessed prior to study, and at visits 6, 7, 10, 11, 16, 17, and 22. Patients are followed for relapse and survival every 3 months for 2.5 years. PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
adult acute myeloid leukemia in remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Drug
Intervention Name(s)
histamine dihydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Berryhill
Organizational Affiliation
Maxim Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Kaiser Permanente-Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sidney Kimmel Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Pacific Hematology/Oncology
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Bethesda Bone Marrow Stem Cell Transplant Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33473
Country
United States
Facility Name
University of Florida Health Science Center - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Oncology and Hematology Associates
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Maine Center for Cancer Medicine and Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Providence Hospital Cancer Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nevada Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Nevada Medical Group-Internal Medicine
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
University of New Mexico Cancer Research & Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Our Lady of Mercy Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
New York Presbyterian Hospital - Cornell Campus
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
West Clinic, P.C.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38117
Country
United States
Facility Name
Boston Cancer Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Cancer Care Institute of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
South Texas Cancer Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Newcastle Mater Misericordiae Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
NSW 2310
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
St. Vincent's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
NSW Breast Cancer Institute
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Wesley Clinic for Hematology/Oncology
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Royal Brisbane Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Mater Public Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Hanson Center for Cancer Research
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Monash Medical Center
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Peter MacCallum Cancer Institute
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
ZIP/Postal Code
6160
Country
Australia
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Queen Elizabeth II Health Science Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Ottawa Regional Cancer Center - General Division
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Seaforth Medical Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada
Facility Name
Hopital Du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
University of Tartu
City
Tartu
ZIP/Postal Code
EE-2400
Country
Estonia
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
FIN-0-0029
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
FIN-7-0211
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Turku University Central Hospital
City
Turku
ZIP/Postal Code
FIN-2-0521
Country
Finland
Facility Name
Centre Hospitalier Regional et Universitaire d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
CHR de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Hopital Andre Mignot
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Centre Hospitalier Regional de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHR Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Zentralklinikum Augsburg
City
Augsburg
ZIP/Postal Code
DOH-8-6156
Country
Germany
Facility Name
Universitaetsklinikum Charite
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Evang. Diakonissenanstalt
City
Bremen
ZIP/Postal Code
D-28239
Country
Germany
Facility Name
Medizinische Klinik I
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Universitaetsklinik und Strahlenklinik - Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Klinikum der J.W. Goethe Universitaet
City
Frankfurt
ZIP/Postal Code
D-60590
Country
Germany
Facility Name
Martin Luther Universitaet
City
Halle Saale
ZIP/Postal Code
DOH-0-6112
Country
Germany
Facility Name
Universitats-Krankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik
City
Heidelberg
ZIP/Postal Code
D-69115
Country
Germany
Facility Name
Staedtische Kliniken Osnabruek
City
Osnabruck
ZIP/Postal Code
DOH-4-9076
Country
Germany
Facility Name
Universitat Rostock
City
Rostock
ZIP/Postal Code
D-18057
Country
Germany
Facility Name
Caritasklinik St. Theresa
City
Saarbrucken
ZIP/Postal Code
D-66113
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Klinikum der Universitaet Ulm
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
Medizinische Poliklinik der Universitat
City
Wurzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petach-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Hospital
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel-Aviv Medical Center-Ichilov Hospital
City
Tel-Aviv
ZIP/Postal Code
62995
Country
Israel
Facility Name
University of Auckland School of Medicine
City
Auckland
ZIP/Postal Code
3
Country
New Zealand
Facility Name
Canterbury Health Laboratories
City
Christchurch
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
2020
Country
New Zealand
Facility Name
Palmerston North Hospital
City
Palmerston North
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
2
Country
New Zealand
Facility Name
County Hospital (Malar Hospital)
City
Eskilstuna
ZIP/Postal Code
63188
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Gothenburg (Goteborg)
ZIP/Postal Code
S-413 45
Country
Sweden
Facility Name
County Hospital/Kalmar
City
Kalmar
ZIP/Postal Code
39185
Country
Sweden
Facility Name
Central Hospital
City
Karlstad
ZIP/Postal Code
65185
Country
Sweden
Facility Name
University Hospital of Linkoping
City
Linkoping
ZIP/Postal Code
S-581 85
Country
Sweden
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
SE-22-1 85
Country
Sweden
Facility Name
Malmo University Hospital
City
Malmo
ZIP/Postal Code
S-20502
Country
Sweden
Facility Name
Regional Hospital
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
County Hospital (Karnsjukhuset)
City
Skovde
ZIP/Postal Code
54185
Country
Sweden
Facility Name
Huddinge Hospital
City
Stockholm
ZIP/Postal Code
S-141 86
Country
Sweden
Facility Name
Karolinska Hospital
City
Stockholm
ZIP/Postal Code
S-171 76
Country
Sweden
Facility Name
County Hospital/Sundsvall
City
Sundsvall
ZIP/Postal Code
85283
Country
Sweden
Facility Name
County Hospital/Uddevalla
City
Uddevalla
ZIP/Postal Code
45189
Country
Sweden
Facility Name
Umea Universitet
City
Umea
ZIP/Postal Code
S-901 85
Country
Sweden
Facility Name
University Hospital - Uppsala
City
Uppsala
ZIP/Postal Code
S-751 85
Country
Sweden
Facility Name
County Hospital/Vasteras
City
Vasteras
ZIP/Postal Code
72189
Country
Sweden
Facility Name
Birmingham Heartlands and Solihull NHS Trust (Teaching)
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Leeds Teaching Hospital Trust
City
Leeds
State/Province
England
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
State/Province
England
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21546500
Citation
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.
Results Reference
result
PubMed Identifier
21429214
Citation
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.
Results Reference
result

Learn more about this trial

Interleukin-2 Plus Histamine Dihydrochloride in Treating Patients With Acute Myeloid Leukemia

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