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OpenTrials
Completed

NCT Number: NCT01453504

Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma

The purpose of this trial is

1. to determine the recommended dose of everolimus for a subsequent Phase II trial 2. to determine the efficacy of everolimus plus DHAP

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

1st Dept. of Medicine, Cologne University Hospital

Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • relapsed or refractory Hodgkin Lymphoma
  • age 18-60
  • histology confirmed relapse

Exclusion criteria

  • previous therapy with mTOR inhibitor
  • current CNS involvement
  • other primary malignant disease within the last 3 years

Treatment and study plan

DHAP

Drug

Dexamethasone, Cytarabine, Cisplatin

Everolimus

Drug

Primary outcomes

  1. Dose Limiting Toxicity Rate (DLT)

    Time frame: 4 weeks

    Phase I primary outcome measure

  2. Complete Remission Rate (CR)

    Time frame: 4 weeks

    Phase II primary outcome measure

Secondary outcomes

  1. Adverse event rate

    Time frame: 4 weeks

    Phase I secondary outcome measure

  2. Tumor status (assessed by CT) after chemotherapy

    Time frame: 4 weeks

    Phase II secondary outcome measure

  3. Tumor status (assessed by PET) after chemotherapy

    Time frame: 4 weeks

    Phase II secondary outcome measure

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

A Prospective, Randomized, Placebo-controlled, Multicenter, International Phase I/II Trial of RAD001 (Everolimus) in Combination With DHAP as Induction Therapy in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Acronym: HD-R3i

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2011
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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