Obinutuzumab Containing Conditioning Regimen for Patients With Poor Risk CLL or Richter's Transformation Requiring Allogeneic Stem Cell Transplantation
NCT03153514 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2022-01-05
Summary
The primary objective of the study is to evaluate the feasibility, efficacy and safety of an obinutuzumab containing conditioning regimen for poor risk CLL patients and patients with Richter's transformation requiring an allogeneic stem cell transplantation.
Conditions
- Chronic Lymphocytic Leukemia
- Richter's Transformation
Interventions
- BIOLOGICAL
-
Obinutuzumab i.v. \[Day 0 = day of stem cell transplant\] Cycle 1: 100 mg (d -8), 900 mg (d -7), 1000 mg (d -1, +7, +14) Cycle 2: 1000 mg (d +1, +8, +15, +22)
Sponsors & Collaborators
- collaborator INDUSTRY
-
German CLL Study Group
lead OTHER
Principal Investigators
-
Michael von Bergwelt-Baildon, Prof. Dr. med. Dr. rer. nat. · University Hospital of Cologne
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-13
- Primary Completion
- 2019-05-16
- Completion
- 2019-06-06
Countries
- Germany
Study Locations
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