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NCT03259503 · ClinicalTrials.gov registry record · Phase 1

Olaparib and High-Dose Chemotherapy in Treating Patients With Relapsed or Refractory Lymphomas Undergoing Stem Cell Transplant

A Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
50
Enrollment target
1
Study location

NCT03259503: Completed Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, sponsored by M.D. Anderson Cancer Center.

NCT03259503 is a Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 50 participants, roughly in line with the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03259503, a Phase 1 study of Recurrent Diffuse Large B-Cell Lymphoma and Refractory Diffuse Large B-Cell Lymphoma, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

This phase I trial studies the side effects and best dose of olaparib when given together with high-dose chemotherapy in treating patients with lymphomas that have come back or does not treatment and are undergoing stem cell transplant. Drugs used in chemotherapy, such as olaparib, vorinostat, gemcitabine, busulfan, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and high-dose chemotherapy together may work better in treating patients with relapsed/refractory lymphomas undergoing stem cell transplant than with chemotherapy alone.

Primary Outcome

All adverse events will be tabulated by dose, and a Bayesian DLT curve will be fit.

Interventions

  • DRUG Melphalan
  • DRUG Busulfan
  • DRUG Olaparib
  • DRUG Gemcitabine
  • PROCEDURE Peripheral Blood Stem Cell Transplantation

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2019-09-13
Est. Completion 2025-11-05
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT03259503 record still lists

NCT03259503 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 47-participant average among 43 other Recurrent Diffuse Large B-Cell Lymphoma trials with a reported enrollment target.

The record links to 5 conditions, with Recurrent Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Melphalan is the first listed.

NCT03259503 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT03259503 about?

NCT03259503 is a clinical study titled "Olaparib and High-Dose Chemotherapy in Treating Patients With Relapsed or Refractory Lymphomas Undergoing Stem Cell Transplant". This phase I trial studies the side effects and best dose of olaparib when given together with high-dose chemotherapy in treating patients with lymphomas that have come back or does not treatment and are undergoing stem cell transplant. Drugs used in chemotherapy, such as olaparib, vorinostat, gemci...

What is the current status of trial NCT03259503?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2019-09-13. Estimated completion is 2025-11-05.

What conditions does trial NCT03259503 study?

This clinical trial studies the following conditions: Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma.

What interventions are being tested in trial NCT03259503?

The interventions under investigation include: Melphalan (DRUG), Busulfan (DRUG), Olaparib (DRUG), Gemcitabine (DRUG), Peripheral Blood Stem Cell Transplantation (PROCEDURE).

Who is sponsoring clinical trial NCT03259503?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03259503 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Recurrent Diffuse Large B-Cell Lymphoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03259503's enrollment target sits among peer trials

50 11th of 43 higher than 33 of 43 other Recurrent Diffuse Large B-Cell Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Diffuse Large B-Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03259503, the US trial registry maintained by the National Library of Medicine. NCT03259503 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.