Clinical trial · Observational
US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)
US Post-Marketing Retrospective Observational Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI)(TM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study stopped due to lack of recruitment.
Summary
Brief summary (as posted)
This study is being conducted to satisfy a post-marketing requirement (PMR) to provide evidence characterizing 1) the safety of moxetumomab pasudotox-tdfk in patients who are 65 years of age and older and/or 2) the safety of moxetumomab pasudotox-tdfk in patients who have moderate renal impairment defined as an estimated GFR of 30-59 ml/min
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 |
|---|---|---|---|
| Hairy Cell Leukemia | Hairy Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- Incident proportion of capillary leak syndrome
- timeFrame
- From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.
- measure
- Incident proportion of hemolytic uremic syndrome
- timeFrame
- From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.
- measure
- Incident proportion of renal toxicity
- timeFrame
- From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.
- measure
- Incident proportion of infusion related reactions
- timeFrame
- From day 1 of moxetumomab pasudotox-tdfk initiation up to 30 days after last dose of moxetumomab pasudotox-tdfk.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Provision of written informed consent, if required * Patient received at least 1 dose of moxetumomab pasudotox-tdfk and has completed or discontinued the treatment * Patient has a medical record available from the start of first dose of moxetumomab pasudotox tdfk AND at least 1 of the following: * Patient is ≥65 years old at the time of starting initial treatment with moxetumomab pasudotox-tdfk OR * Adult (≥18 years old) patient has moderate renal impairment, at the time of starting initial treatment with moxetumomab pasudotox-tdfk
References
Publications (8)
- BACKGROUNDBouroncle BA. Thirty-five years in the progress of hairy cell leukemia. Leuk Lymphoma. 1994;14 Suppl 1:1-12. PMID 7820038
- BACKGROUNDJemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43. PMID 17237035
- BACKGROUNDKreitman 2018, Leukemia https://doi.org/10.1038/s41375-018-0210-1
- BACKGROUNDKreitman RJ, Cheson BD. Malignancy: Current Clinical Practice: Treatment of Hairy Cell Leukemia at the Close of the 20th Century. Hematology. 1999;4(4):283-303. doi: 10.1080/10245332.1999.11746452. PMID 11399570
- BACKGROUNDKroft SH, Tallman MS, Shaw JM, Thangavelu M, Peterson LC. Myelodysplasia following treatment of chronic lymphocytic leukemia (CLL) with 2-chlorodeoxyadenosine (2-CdA). Leukemia. 1997 Jan;11(1):170. doi: 10.1038/sj.leu.2400523. No abstract available. PMID 9001435
- BACKGROUNDLeleu X, Soumerai J, Roccaro A, Hatjiharissi E, Hunter ZR, Manning R, Ciccarelli BT, Sacco A, Ioakimidis L, Adamia S, Moreau AS, Patterson CJ, Ghobrial IM, Treon SP. Increased incidence of transformation and myelodysplasia/acute leukemia in patients with Waldenstrom macroglobulinemia treated with nucleoside analogs. J Clin Oncol. 2009 Jan 10;27(2):250-5. doi: 10.1200/JCO.2007.15.1530. Epub 2008 Dec 8. PMID 19064987
- BACKGROUNDSeymour JF, Kurzrock R, Freireich EJ, Estey EH. 2-chlorodeoxyadenosine induces durable remissions and prolonged suppression of CD4+ lymphocyte counts in patients with hairy cell leukemia. Blood. 1994 May 15;83(10):2906-11. PMID 7910051
- BACKGROUNDSeymour JF, Talpaz M, Kurzrock R. Response duration and recovery of CD4+ lymphocytes following deoxycoformycin in interferon-alpha-resistant hairy cell leukemia: 7-year follow-up. Leukemia. 1997 Jan;11(1):42-7. doi: 10.1038/sj.leu.2400513.