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NCT01476839 · ClinicalTrials.gov registry record · Phase 1

Radiolabeled Monoclonal Antibody Therapy and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Primary Refractory or Relapsed Hodgkin Lymphoma

A Phase 1 study of Recurrent Adult Hodgkin Lymphoma, sponsored by City of Hope Medical Center.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target
1
Study location

NCT01476839: Completed Phase 1 study of Recurrent Adult Hodgkin Lymphoma, sponsored by City of Hope Medical Center.

NCT01476839 is a Phase 1 study of Recurrent Adult Hodgkin Lymphoma that has completed, run by City of Hope Medical Center. The registered enrollment target is 25 participants, below the 29-participant average among 4 other Recurrent Adult Hodgkin Lymphoma trials with a reported enrollment target (14% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01476839, a Phase 1 study of Recurrent Adult Hodgkin Lymphoma, has completed, sponsored by City of Hope Medical Center.

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

Study Summary

This phase I clinical trial studies the side effects and best dose of radiolabeled monoclonal antibody therapy when given together with combination chemotherapy before stem cell transplant and to see how well it works in treating patients with primary refractory (did not respond to treatment) or relapsed (returned after treatment) Hodgkin lymphoma. Radiolabeled monoclonal antibodies can find cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan (BEAM), work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving radiolabeled monoclonal antibody therapy together with combination chemotherapy may kill more cancer cells

Primary Outcome

RP2D will generally be the highest maximum tolerated dose (MTD), but it may be less than the MTD based on a review of available data/cumulative toxicities. Additional pulmonary toxicity monitoring will be performed among enrolled/treated patients with prior brentuximab vedotin exposure for both portions of the study.

Interventions

  • DRUG etoposide
  • DRUG melphalan
  • DRUG carmustine
  • DRUG cytarabine
  • BIOLOGICAL basiliximab

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2012-11-09
Est. Completion 2024-05-31
Phase Phase 1
City of Hope Medical Center

582 total trials

What the finished NCT01476839 record still lists

NCT01476839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 29-participant average among 4 other Recurrent Adult Hodgkin Lymphoma trials with a reported enrollment target (14% lower).

The record links to 1 condition, with Recurrent Adult Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which etoposide is the first listed.

NCT01476839 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT01476839 about?

NCT01476839 is a clinical study titled "Radiolabeled Monoclonal Antibody Therapy and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Primary Refractory or Relapsed Hodgkin Lymphoma". This phase I clinical trial studies the side effects and best dose of radiolabeled monoclonal antibody therapy when given together with combination chemotherapy before stem cell transplant and to see how well it works in treating patients with primary refractory (did not respond to treatment) or rel...

What is the current status of trial NCT01476839?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2012-11-09. Estimated completion is 2024-05-31.

What conditions does trial NCT01476839 study?

This clinical trial studies the following conditions: Recurrent Adult Hodgkin Lymphoma.

What interventions are being tested in trial NCT01476839?

The interventions under investigation include: etoposide (DRUG), melphalan (DRUG), carmustine (DRUG), cytarabine (DRUG), basiliximab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01476839?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01476839 being conducted?

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

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Source: ClinicalTrials.gov NCT01476839, the US trial registry maintained by the National Library of Medicine. NCT01476839 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.