Clinical trial · Observational
Composite Health Assessment Risk Model (CHARM) for Older Adults (BMT CTN 1704)
Composite Health Assessment Risk Model (CHARM) for Older Adults: Applying Pre-Transplant Comorbidity, Geriatric Assessment, and BioMarkers on Non-Relapse Mortality After Allogeneic Transplant (BMT CTN 1704)
NCT03992352CI-TRIAL-00073650BMT CTN 1704completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective observational multicenter study of allogeneic Hematopoietic Stem Cell Transplantation (HCT) in recipients 60 years and older to assess important determinants of health status to be combined into a composite health risk model to improve risk assessment of non-relapse mortality (NRM).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Age 60+ with planned HCT for Hematologic Malignancy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Age 60+ with planned HCT for Hematologic Malignancy
- description
- Subjects 60 years or older with a planned allogeneic transplantation for a hematologic malignancy.
- interventionNames
- Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy
Primary outcomes (1)
- measure
- One Year Non-Relapse Mortality
- timeFrame
- 1 year
- description
- To determine the set of assessments and biomarkers that could together constitute a robust and valid composite health risk model for accurate personalized estimation of NRM by analyzing data collected from all measures pre and post transplant.
Secondary outcomes (13)
- measure
- Overall survival
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is \> 60.0 years old at time of enrollment. 2. Hematological malignancy as an indication for allogeneic transplantation. 3. Eligible for allogeneic transplantation based on institutional standards 4. First allogeneic transplant planned. Any conditioning regimen and allogeneic donor is acceptable. 5. Able to speak and read English. Spanish, and Mandarin will be acceptable when sites have ability to perform healthcare provider tests in those languages. 6. Written informed consent Exclusion Criteria: 1\. Prior allogeneic HCT
References
Publications (31)
- BACKGROUNDPidala J, Craig BM, Lee SJ, Majhail N, Quinn G, Anasetti C. Practice variation in physician referral for allogeneic hematopoietic cell transplantation. Bone Marrow Transplant. 2013 Jan;48(1):63-7. doi: 10.1038/bmt.2012.95. Epub 2012 Jun 18. PMID 22705801
- BACKGROUNDAppelbaum FR, Anasetti C, Antin JH, Atkins H, Davies S, Devine S, Giralt S, Heslop H, Laport G, Lee SJ, Logan B, Pasquini M, Pulsipher M, Stadtmauer E, Wingard JR, Horowitz MM. Blood and marrow transplant clinical trials network state of the Science Symposium 2014. Biol Blood Marrow Transplant. 2015 Feb;21(2):202-24. doi: 10.1016/j.bbmt.2014.10.003. Epub 2014 Oct 15. No abstract available. PMID 25445636
- BACKGROUNDJuliusson G, Lazarevic V, Horstedt AS, Hagberg O, Hoglund M; Swedish Acute Leukemia Registry Group. Acute myeloid leukemia in the real world: why population-based registries are needed. Blood. 2012 Apr 26;119(17):3890-9. doi: 10.1182/blood-2011-12-379008. Epub 2012 Mar 1. PMID 22383796
- BACKGROUNDMrozek K, Marcucci G, Nicolet D, Maharry KS, Becker H, Whitman SP, Metzeler KH, Schwind S, Wu YZ, Kohlschmidt J, Pettenati MJ, Heerema NA, Block AW, Patil SR, Baer MR, Kolitz JE, Moore JO, Carroll AJ, Stone RM, Larson RA, Bloomfield CD. Prognostic significance of the European LeukemiaNet standardized system for reporting cytogenetic and molecular alterations in adults with acute myeloid leukemia. J Clin Oncol. 2012 Dec 20;30(36):4515-23. doi: 10.1200/JCO.2012.43.4738. Epub 2012 Sep 17. PMID 22987078
- BACKGROUNDBurnett AK, Russell NH, Hills RK, Kell J, Nielsen OJ, Dennis M, Cahalin P, Pocock C, Ali S, Burns S, Freeman S, Milligan D, Clark RE. A comparison of clofarabine with ara-C, each in combination with daunorubicin as induction treatment in older patients with acute myeloid leukaemia. Leukemia. 2017 Feb;31(2):310-317. doi: 10.1038/leu.2016.225. Epub 2016 Sep 2. PMID 27624670
- BACKGROUNDRashidi A, Ebadi M, Colditz GA, DiPersio JF. Outcomes of Allogeneic Stem Cell Transplantation in Elderly Patients with Acute Myeloid Leukemia: A Systematic Review and Meta-analysis. Biol Blood Marrow Transplant. 2016 Apr;22(4):651-657. doi: 10.1016/j.bbmt.2015.10.019. Epub 2015 Oct 31.