Acute GvHDPhase 1/2ALD518-010NCT01530256

Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)

A Phase 1/2 study testing ALD518 in people with Acute GvHD, run by CSL Behring at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further investigation in Part B. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute GvHD
What is being tested?: ALD518
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 5 sitesUnited States
Study dates: Mar 2012to Mar 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Glucocorticosteroid refractory acute GVHD Grade 2-4
Prior corticosteroid therapy at > 1.0mg/kg methylprednisolone or equivalent for minimum of 3 and maximum of 14 days
Karnofsky Performance Satus Scale ≥ 50%
Adequate laboratory testing at screening

Who cannot join

Subjects having Stage 1 skin acute GVHD
Subjects with Stage 3 or 4 liver GVHD
Prior EBV associated malignancy
Prior or current Hepatitis B or C
Prior or active tuberculosis

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

The Ohio State University
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
Loyola Medical Center
Maywood, Illinois, 60153
Virginia Commonwealth University
Richmond, Virginia, 23298
Washington University
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: An Exploratory Phase 1/2 Clinical Trial Evaluating ALD518 in Subjects With Glucocorticoid-Refractory Acute Graft vs. Host Disease (GVHD) After Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

Conditions: Acute GvHD
Being tested: ALD518
Keywords: allograph, steroid refractory

What participants receive

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

ALD518Biological
160 mg IV q 4 weeks for 4 doses
ALD518Biological
320 mg IV q 4 weeks for 4 doses
ALD518Biological
640 mg IV q 4 weeks for 2 doses

Study groups in NCT01530256
Study group	Role	What they receive
ALD518	Experimental	Not described Receives: Biological: ALD518

What is being measured

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

Number of Participants With Adverse Events, Including Infections and Loss of Engraftment
Measured: Through Week 24
Number of Participants With Acute GVHD Response at Week 4
Includes calculation of both complete and partial response. Complete response = functional grade of 0 for the GVHD grading in all evaluable organs. Partial response = improvement by one or more functional grades in one or more organs involved with GVHD symptoms without progression in others, or a very good partial response which is a partial response plus all of the following: (1) skin - active erythematous rash involving less than 25% of body surface, (2) liver - total bilirubin <2 mg/dL or a 25% reduction from baseline (if >2 mg/dL), (3) gut - greater than or equal to 75% reduction in daily stool volume.
Measured: Week 4

Secondary outcomes (3)

Number of Participants With Relapse of Underlying Malignant Disease
Measured: Through Week 24
Number of Participants With Overall Survival
Measured: Through Week 24
Change in Patient Reported Outcomes as Measured by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Questionnaire Score
The FACT-BMT assesses bone marrow transplant related concerns. The total score is the sum of sub-scale scores for 5 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Bone Marrow Transplantation Subscale. Within each domain, a 5-point Likert-type scale (from 0-4) is used to measure the responses for each question. After taking into account reverse scores for questions constructed in a negative form, the subscale score for each domain is calculated by multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The final score for FACT-BMT ranges from 0 to 148. Higher scores indicate better quality of life.
Measured: Up to 20 weeks

Timeline

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

Mar 2012Mar 2013

First posted9 Feb 2012 (estimated)
Study startMar 2012
Primary completionMar 2013
Study completionMar 2013

Why it stopped: The trial was terminated in line with the endpoint committee charter.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute GvHDStudies of the same condition, open and under way.
More trials run by CSL BehringThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01530256
Sponsor's protocol ID: ALD518-CLIN-010
Acronym: ALD518-010
Status last verified: Feb 2021
First submitted: 6 Feb 2012
Last updated: 17 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Phase 1/2 Clinical Trial Evaluating ALD518 in Subjects With Glucocorticoid-Refractory Acute Graft vs. Host Disease (GVHD) After Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
ClinicalTrials.gov ID: NCT01530256
Acronym / sponsor ID: ALD518-010 / ALD518-CLIN-010
Conditions: Acute GvHD
Keywords: allograph, steroid refractory
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The trial was terminated in line with the endpoint committee charter.
Enrolment: 3 participants (actual)
Lead sponsor: CSL BehringIndustry (pharma, biotech, devices)
Study start: Mar 2012 (actual)
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 9 Feb 2012 (estimated)
Results: Posted 17 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ALD518	Experimental	Biological: ALD518

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Glucocorticosteroid refractory acute GVHD Grade 2-4
Prior corticosteroid therapy at > 1.0mg/kg methylprednisolone or equivalent for minimum of 3 and maximum of 14 days
Karnofsky Performance Satus Scale ≥ 50%
Adequate laboratory testing at screening

Key exclusion criteria (5 listed)

Subjects having Stage 1 skin acute GVHD
Subjects with Stage 3 or 4 liver GVHD
Prior EBV associated malignancy
Prior or current Hepatitis B or C
Prior or active tuberculosis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALD518160 mg IV q 4 weeks for 4 doses	Biological	ALD518
ALD518320 mg IV q 4 weeks for 4 doses	Biological	ALD518
ALD518640 mg IV q 4 weeks for 2 doses	Biological	ALD518

Primary outcome

Number of Participants With Adverse Events, Including Infections and Loss of Engraftment
Time frame: Through Week 24
Number of Participants With Acute GVHD Response at Week 4
Time frame: Week 4
Includes calculation of both complete and partial response. Complete response = functional grade of 0 for the GVHD grading in all evaluable organs. Partial response = improvement by one or more functional grades in one or more organs involved with GVHD symptoms without progression in others, or a very good partial response which is a partial response plus all of the following: (1) skin - active erythematous rash involving less than 25% of body surface, (2) liver - total bilirubin <2 mg/dL or a 25% reduction from baseline (if >2 mg/dL), (3) gut - greater than or equal to 75% reduction in daily stool volume.

3 secondary outcomes

Number of Participants With Relapse of Underlying Malignant Disease
Time frame: Through Week 24
Number of Participants With Overall Survival
Time frame: Through Week 24
Change in Patient Reported Outcomes as Measured by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Questionnaire Score
Time frame: Up to 20 weeks

Results and safety

Results posted to the registry on 17 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ALD518	3	1

Primary outcome: Number of Participants With Adverse Events, Including Infections and Loss of Engraftment

Time frame: Through Week 24. Number. Unit: participants

Measure	ALD518 n = 3
Value	3

Primary outcome: Number of Participants With Acute GVHD Response at Week 4

Time frame: Week 4. Number. Unit: participants

Measure	ALD518 n = 1
Value	0

Population analysed: 2 of 3 participants died before Week 4 so could not be assessed

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to death or termination of study (approximately 139 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ALD518	3 of 3 (100%)	3 of 3 (100%)	2 of 3

Limitations and caveats (from the sponsor): Formal analyses were not conducted. Profiles of each enrolled subject were produced. Due to a limited number of samples, pharmacokinetics and anti-ALD518 antibodies analyses were not conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Javier San Martin, MD FRCP study director

Alder Biopharmaceuticals, Inc.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ALD518 in people with Acute GvHD, run by CSL Behring at 5 sites in United States.

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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 17 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events, Including Infections and Loss of Engraftment (time frame: Through Week 24). 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 NCT01530256.

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 17 Feb 2021.