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Radiation Dose Optimization in Diffuse Large B- Cell Lymphoma.

Study acronym: DOBL
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 11, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Phase: Phase 3 to Not applicable Primary completion date: Nov 2022 to Mar 2026 · Completion date: Jun 2023 to Nov 2027v5 Show 2 more changesShow less
    • Primary completion date: Nov 2022 to Mar 2026
    • Completion date: Jun 2023 to Nov 2027
  2. Eligibility criteria revisedv4 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  4. Primary completion date: Nov 2024 to Nov 2022 Completion date: Jun 2025 to Jun 2023 · Secondary endpoints: details revised at 6 of 6 entries · Study description expanded, about 1 wordv2 Show 3 more changesShow less
    • Completion date: Jun 2025 to Jun 2023
    • Secondary endpoints: details revised at 6 of 6 entries
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to compare standard dose radiation of 45 Gray(Gy) in 25 fractions in Non Hodgkin's Lymphoma- Diffuse Large B cell Lymphoma (NHL-DLBCL) to that of 36 Gy in 20 fractions. The role of radiation in NHL-DLBCL has been addressed in large cooperative trials showing improvement in overall survival and progression free survival with combined modality treatment. The doses of radiation used in these trials are heterogeneous ranging from 30-55 Gray(Gy). There is uncertainty about the optimal dose of radiation needed in aggressive lymphomas. A dose response phenomenon is known in Non- Hodgkin's Lymphoma. Late effects of higher dose radiation in the form of higher risk of stroke, myocardial infarction, thyroid abnormalities and secondary breast cancer are being increasingly identified. Hence it is essential to optimize the dose of radiotherapy for lower toxicity without compromising on efficacy.
Trial Details
NCT Number NCT02964858
Lead Sponsor Tata Memorial Hospital
Conditions NonHodgkin Lymphoma
Enrollment 840 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov