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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00003991

Public ClinicalTrials.gov record NCT00003991. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 8:56 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00003991
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Maxim Pharmaceuticals
Industry
Enrollment
360 participants

Conditions and interventions

Conditions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 1998
Primary completion
Not listed
Completion
Jul 31, 2011
Last update posted
Nov 5, 2013

1998 – 2011

United States locations

U.S. sites
32
U.S. states
17
U.S. cities
29
Facility City State ZIP Site status
University of Alabama Comprehensive Cancer Center Birmingham Alabama 35294
Arizona Cancer Center Tucson Arizona 85724
Scripps Clinic La Jolla California 92037
Cedars-Sinai Medical Center Los Angeles California 90048
Kaiser Permanente-Southern California Permanente Medical Group San Diego California 92120
Sidney Kimmel Cancer Center San Diego California 92121
Pacific Hematology/Oncology San Francisco California 94115
Bethesda Bone Marrow Stem Cell Transplant Institute Boynton Beach Florida 33473
University of Florida Health Science Center - Jacksonville Jacksonville Florida 32209
Emory University Hospital - Atlanta Atlanta Georgia 30322
University of Kansas Medical Center Kansas City Kansas 66160-7357
Oncology and Hematology Associates Westwood Kansas 66205
Maine Center for Cancer Medicine and Blood Disorders Scarborough Maine 04074
Henry Ford Hospital Detroit Michigan 48202
Providence Hospital Cancer Center Southfield Michigan 48075
Washington University School of Medicine St Louis Missouri 63110
Nevada Cancer Center Las Vegas Nevada 89106
Nevada Medical Group-Internal Medicine Reno Nevada 89502
University of New Mexico Cancer Research & Treatment Center Albuquerque New Mexico 87131
New York Presbyterian Hospital - Cornell Campus New York New York 10021
University of Rochester Cancer Center Rochester New York 14642
Our Lady of Mercy Medical Center The Bronx New York 10466
New York Medical College Valhalla New York 10595
Ireland Cancer Center Cleveland Ohio 44106-5065
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73190
University of Pennsylvania Cancer Center Philadelphia Pennsylvania 19104
Western Pennsylvania Hospital Pittsburgh Pennsylvania 15224
West Clinic, P.C. Memphis Tennessee 38117
Boston Cancer Group Memphis Tennessee 38119
Baylor University Medical Center Dallas Texas 75246
Cancer Care Institute of South Texas San Antonio Texas 78229
South Texas Cancer Institute San Antonio Texas 78229

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 86 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00003991, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 5, 2013 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00003991 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →