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Trial record 96 of 1216 for:    "Hodgkin lymphoma"

Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma (HD-R3i)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01453504
Recruitment Status : Recruiting
First Posted : October 18, 2011
Last Update Posted : October 29, 2018
Information provided by (Responsible Party):
Prof. Dr. Peter Borchmann, University of Cologne

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: DHAP Drug: Everolimus Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Study Start Date : August 2012
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: Ever-DHAP
Combination of Everolimus and DHAP
Drug: DHAP
Dexamethasone, Cytarabine, Cisplatin

Drug: Everolimus
Placebo Comparator: Placebo-DHAP Drug: DHAP
Dexamethasone, Cytarabine, Cisplatin

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01453504

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Contact: Michael Fuchs

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1st Dept. of Medicine, Cologne University Hospital Recruiting
Cologne, Germany
Contact: Michael Fuchs   
Sponsors and Collaborators
University of Cologne
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Study Chair: Peter Borchmann, Prof. University of Cologne, German Hodgkin Study Group

Additional Information:
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Responsible Party: Prof. Dr. Peter Borchmann, Prof., University of Cologne Identifier: NCT01453504     History of Changes
Other Study ID Numbers: HD-R3i
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents