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Chronic Lymphatic LeukemiaPhase 2NCT01809847

Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation

A Phase 2 study testing Ofatumumab in people with Chronic Lymphatic Leukemia, run by Technische Universität Dresden at 11 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To study the safety and efficacy of anti-CD20 blockade with ofatumumab in the context of allogeneic HCT in CLL Read more about this study

Who is it for?
Ages 56 years and older
Conditions the study is for
Chronic Lymphatic Leukemia
What is being tested?
Ofatumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
11 sitesGermany
Study dates
Mar 2013to Jan 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 56 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of CLL according to WHO criteria (Hallek 2008) confirmed by flow cytometry of peripheral blood or bone marrow
  • Age > 55 years
  • Poor-risk disease according to the EBMT CLL Transplant Consensus
  • Non-response or early relapse (within 12 months) after purine analogue-containing therapy
  • Relapse (within 24 months) after purine analogue combination therapy or treatment of similar efficacy (ie, autologous stem cell transplantation)
  • p53 deletion/mutation (del 17p-) requiring treatment
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  • Measurable disease in the peripheral blood defined by a minimum clonal lymphocyte count of 0.5 GPT/L at the time of study inclusion
  • Medically fit patients eligible for allogeneic HCT
  • Informed consent for related and unrelated donor search and the goal to perform allogeneic HCT
  • Sexually mature males must agree to use adequate and medically accepted method of contraception throughout the study if their sexual partners are woman of child bearing potential (WOCBP) WOCBP must be using an adequate and medically accepted method of contraception to avoid pregnancy throughout the study and for at least 3 months after the study.
  • WOCBP includes any female that has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >12 consecutive months); or woman on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level >35mlU/mL.
  • WOCBP must have a negative serum or urine pregnancy test prior to the start of the study.

Who cannot join

  • Richter's transformation in current relapse or active disease
  • Prior allogeneic HCT
  • Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or participation in any other interventional clinical study
  • Non-response to monotherapy with ofatumumab prior to study inclusion
  • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (left ventricular ejection fraction < 50%)
  • Abnormal renal function defined by an estimated GFR < 50 ml/min
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  • Abnormal lung function tests defined by a DLCO <50%, FEV1%VC <70% despite appropriate treatment
  • Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg or HBcAb
  • Positive serology for hepatitis C (HC) defined as a positive test for anti-HCV, confirmed by PCR
  • Screening laboratory values:
  • total bilirubin >1.5 times upper normal limit (unless due to AIHA or a known history of Gilbert's disease)
  • ALT or AST >2.5 times upper normal limit
  • Gamma glutamyl transpeptidase (GGT) >2.5 times upper normal limit (unless due to disease involvement of the liver)
  • Other past or current hematologic or solid organ malignancy. Subjects who have been free of malignancy for at least 3 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
  • Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
  • Pregnant or lactating woman
  • Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Germany11 sites

  • Klinikum Chemnitz GmbH

    Chemnitz, Saxony, 09113

  • Klinikum der Universität zu Köln

    Cologne, North Rhine-Westphalia, 50937

  • Universitätsklinikum Dresden

    Dresden, Saxony, 01307

  • Universitätsklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), Brandenburg, 15236

  • Universitätsmedizin Göttingen

    Göttingen, Lower Saxony, 37075

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Klinikum der Johannes Gutenberg Universität

    Mainz, Rhineland-Palatinate, 55131

  • Städtisches Klinikum München Schwabing

    München, Bavaria, 80804

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

  • Deutsche Klinik für Diagnostik

    Wiesbaden, Hesse, 65191

Other trials in Germany

About this study

Official title: Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation(CLL-X4 Trial)

To study the safety and efficacy of anti-CD20 blockade with ofatumumab in the context of allogeneic HCT in CLL

Read the detailed description

The goal of the study is to investigate the safety and efficacy of a consequent anti-CD20 therapy with the antibody ofatumumab in the context of allogeneic HCT. Allogeneic HCT itself is not a study intervention and is triggered by the availability of an HLA-compatible stem cell donor. The study is divided into an induction part and a maintenance part. During induction where the antibody is combined with high dose dexamethasone, the main goal is to reduce the tumor load prior to allogeneic HCT. Patients who achieved disease control (CR, PR and SD) by the antibody proceed to maintenance therapy with the antibody. Patients with progressive disease go off study. The idea behind maintenance therapy is that ofatumumab may contribute to tumor control early after allogeneic stem cell transplantation while T-cell based graft-versus leukemia effects are still not fully established. External tumor control could lower the pressure to taper immunosuppressive drugs early after transplantation and could thereby indirectly contribute to better GVHD-prophylaxis. Furthermore, anti-CD20 antibodies have proven activity in the treatment of chronic GVHD. In summary, the concept of a consequent CD20 blockade in the context of allogeneic transplantation could result in better leukemic control and better GVHD prophylaxis, which is a highly attractive goal.

Being tested
Ofatumumab
Keywords
CLL, Chronic Lymphatic Leukemia, Leukemia, HLA, Histocompatibility, HCT, hematopoietic stem cell transplantation, Ofatumumab, CD20
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OfatumumabDrug

    Also called Arzerra, Anti-CD20 antibody

    Study treatment comprises eight weeks of induction therapy with ofatumumab in combination with high-dose dexamethasone. The first dose of ofatumumab is 300 mg followed by seven infusions of 2000 mg ofatumumab. Dexamethasone will be given orally at doses of 40 mg on days 1-4 in weeks 1, 3, 5, and 7. Patients who achieved a CR, PR shall proceed to maintenance therapy. Maintenance therapy consists of 6 monthly infusions of 1000 mg ofatumumab.

    An HLA-matched sibling donor or HLA-matched unrelated donor can be identified for approximately 70% of patients. Donor search will be completed within six weeks for 95% of the patients. Patients with a donor will proceed to allogeneic HCT as soon as possible prior to, or during maintenance therapy.

Study groups in NCT01809847
Study groupRoleWhat they receive
OfatumumabExperimentalFirst dose of 300 mg Ofatumumab followed by seven weekly infusions of 2000 mg. Dexamethasone will be given orally at doses of 40 mg on days 1-4 in weeks 1, 3, 5, and 7. Maintenance therapy consists of 6 monthly infusions of 1000 mg ofatumumab.
Receives: Drug: Ofatumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate after induction therapy

    efficacy analysis of anti-CD20 blockade with ofatumumab

    Measured: week 9

  2. rate of MRD-negative patients

    rate of MRD-negative patients who did not experience relapse, progression or death within the first 14 months after study enrollment

    Measured: baseline, week 9, month 14

Secondary outcomes (6)

  1. Rate of allogeneic HCT

    Rate of patients who reach allogeneic HCT if HLA-matched donor is available

    Measured: month 9

  2. adverse drug reactions grade III/IV

    Measured: week 1 till week 9; month 4 till month 9; month 12; month 14; until 30 days after last administration of the study medication

  3. Overall, event-, and progression free survival

    Measured: week 1 till week 9; month 4 till month 9; month 12; month 14; up to 5 years follow-up

  4. relapse incidence

    Measured: month 4 till month 9; month 12; month 14; up to 5 years follow-up

  5. non-relapse mortality

    Measured: week 1 till week 9; month 4 till month 9; month 12; month 14; up to 5 years follow-up

  6. Incidences of acute and chronic GVHD

    provided that allogeneic HCT was conducted

    Measured: during maintenance therapy; month 12, month 14; up to 5 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01809847
Sponsor's protocol ID
TUD-CLL-X4-054
Other IDs
2012-001947-31
Status last verified
Sep 2016
First submitted
18 Dec 2012
Last updated
19 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ofatumumab in people with Chronic Lymphatic Leukemia, run by Technische Universität Dresden at 11 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate after induction therapy (time frame: week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01809847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.

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