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

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ClinicalTrials.gov Identifier: NCT01453504
Recruitment Status : Recruiting
First Posted : October 18, 2011
Last Update Posted : October 29, 2018
Sponsor:
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

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



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

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 ClinicalTrials.gov identifier (NCT number): NCT01453504


Contacts
Contact: Michael Fuchs ghsg@uk-koeln.de

Locations
Germany
1st Dept. of Medicine, Cologne University Hospital Recruiting
Cologne, Germany
Contact: Michael Fuchs       ghsg@uk-koeln.de   
Sponsors and Collaborators
University of Cologne
Investigators
Study Chair: Peter Borchmann, Prof. University of Cologne, German Hodgkin Study Group

Additional Information:
Responsible Party: Prof. Dr. Peter Borchmann, Prof., University of Cologne
ClinicalTrials.gov 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:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents