Trial reportHaematologica2011
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.
Trial report in Haematologica, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00003991 (Multi-Center, Randomized Open-Label Study to Evaluate the Safety and Efficacy of Immunotherapy With Subcutaneous Maxamine), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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)
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- Pooled it
- Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2017Pooled it
- Pooled it
- Relationship between event-free survival and overall survival in acute myeloid leukemia: a report from SWOG, HOVON/SAKK, and MRC/NCRI.Haematologica · 2016Trial
- NK cell expression of natural cytotoxicity receptors may determine relapse risk in older AML patients undergoing immunotherapy for remission maintenance.Oncotarget · 2015Trial
- Histamine dihydrochloride and low-dose interleukin-2 in an emerging landscape of relapse prevention in acute myeloid leukemia.Therapeutic advances in hematology · 2025Review
- Review
- Article
- Histamine in cancer immunology and immunotherapy. Current status and new perspectives.Pharmacology research & perspectives · 2021Review
- MiR-9 functions as a tumor suppressor in acute myeloid leukemia by targeting CX chemokine receptor 4.American journal of translational research · 2019Article
- Article
- Mixed-phenotype acute leukemia: suboptimal treatment when the 2008/2016 WHO classification is used.Blood research · 2016Article
- Impact of Copula Directional Specification on Multi-Trial Evaluation of Surrogate End Points.Journal of biopharmaceutical statistics · 2015Article
- Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints.Computational statistics & data analysis · 2014Article
- Optimal therapy for adult patients with acute myeloid leukemia in first complete remission.Current treatment options in oncology · 2014Review
- Markers for nutrition studies: review of criteria for the evaluation of markers.European journal of nutrition · 2013Review
- Endpoints in advanced breast cancer: methodological aspects & clinical implications.The Indian journal of medical research · 2011Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn trials designed to evaluate new therapies for hematologic malignancies, end points such as leukemia-free survival are often used as surrogates for overall survival in acute leukemia. We aimed to assess whether leukemia-free survival is an acceptable statistical surrogate for overall survival when applied to remission maintenance therapy for acute myeloid leukemia. DESIGN AND
methodsData were analyzed from a randomized Phase III trial of remission maintenance immunotherapy with histamine dihydrochloride plus low-dose interleukin-2 versus no treatment in adults with acute myeloid leukemia. A two-stage surrogate validation model was applied in which correlations between Kaplan-Meier estimates of leukemia-free survival and overall survival, and between log hazard ratios reflecting treatment effects were analyzed. Country of patient enrollment was the unit of analysis.
resultsKaplan-Meier estimates of overall survival at 36, 48, and 60 months and leukemia-free survival at 24 months were reasonably correlated (R(2) ranging from 0.44 to 0.84) both for the overall (n=320) and first complete remission (n=261) populations. The effects of histamine dihydrochloride/interleukin-2 on log hazard ratios for leukemia-free survival and overall survival were well correlated (R(2)=0.88-0.93).
conclusionsThe significant correlations between overall survival and the surrogate end point (leukemia-free survival) and between the effect of histamine dihydrochloride/interleukin-2 on leukemia-free survival and overall survival satisfy the two-stage surrogate validation model.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.