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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 Oct 27, 2026, 4:54 AM 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
Jul 1998 (Type not available)
Primary completion
Not listed
Completion
Aug 2011 (Actual)
Last update posted
Nov 6, 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 6, 2013 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00003991 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →