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

U

University of Cologne

Status and phase

Completed
Phase 2
Phase 1

Conditions

Hodgkin Lymphoma

Treatments

Drug: Everolimus
Drug: DHAP

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

73 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

73 participants in 2 patient groups, including a placebo group

Ever-DHAP
Active Comparator group
Description:
Combination of Everolimus and DHAP
Treatment:
Drug: DHAP
Drug: Everolimus
Placebo-DHAP
Placebo Comparator group
Treatment:
Drug: DHAP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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