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Leukemia, Acute MyeloidPhase 1NCT01700751

Brentuximab Vedotin Prevention of (GVHD) After Unrelated Allogeneic Stem Cell Transplantation

A Phase 1 study testing brentuximab vedotin in people with Leukemia, Acute Myeloid and Leukemia, Lymphoblastic,Acute, run by Washington University School of Medicine at 1 site in United States.

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

This pilot clinical trial studies the safety and maximum tolerated dose of brentuximab vedotin when given with tacrolimus and methotrexate after unrelated allogeneic donor stem cell transplant in patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
brentuximab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
25 Feb 2013to 21 Nov 2016
Phase
Phase 1
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be scheduled to undergo stem cell transplantation for one of the following diagnoses:
  • acute myeloid leukemia (AML) in CR1 (first complete remission, CR or CRi) or CR2 (second complete remission, CR or CRi),
  • acute lymphoblastic leukemia (ALL) in CR1 or CR2 (CR or CRi)
  • myelodysplastic syndrome (MDS) without progression to AML.
  • Chronic myelogenous leukemia (CML)
  • Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD)
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  • Chronic lymphocytic leukemia (CLL)
  • Multiple myeloma (MM)
  • Patients must be the recipient of unrelated donor peripheral blood stem cell products. Mismatches at both antigen and allele level will be eligible. Match must be 6 or 7 out of 8 loci (HLA A, B, C, and DRB1).
  • Patient must receive any one of the following conditioning regimens: total body radiation (single or fractionated dose)/cyclophosphamide, busulfan/ cyclophosphamide, or fludarabine/busulfan/lymphocyte immune globulin (ATGAM/thymo).
  • Patient must be ≥ 18 years and ≤ 70 years of age.
  • Patient must have an ECOG performance status ≤ 2 or Karnofsky performance scale ≥ 60%
  • Patient must have CD34+ stem cells ≥ 2x106/kg (actual body weight of the recipient) available for transplantation.
  • Patient must have appropriate organ function as defined below (this criterion should be met on screening and on the day of the first dose of brentuximab vedotin (as assessed prior to dosing)):
  • Total bilirubin ≤ 2.0 x IULN
  • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  • Serum creatinine ≤ 2.0 x IULN
  • Estimated Creatinine Clearance > 30 ml/min
  • Cardiac ejection fraction > 40%
  • DLCO/VA > 40%
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Patient must be able to understand and willing to sign an IRB approved written informed consent document.

Who cannot join

  • Patient must not have had prior exposure to brentuximab vedotin.
  • Patient must not have a history of other malignancy that has not been in remission for at least 3 years, with the exception of basal non-melanoma skin cancer which were treated with local resection only or intraepithelial lesions or carcinoma in situ of the cervix or prostate that has been curatively treated.
  • Patient must not be receiving any other investigational agents.
  • Patient must not have active CNS involvement.
  • Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to brentuximab vedotin or other agents used in the study.
  • Patients must not have had previous radiation therapy to the mediastinum or lungs.
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  • Patient must not have an uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active pulmonary diseases, or psychiatric illness/social situations that would limit compliance with study requirements (this criterion should be met on screening and on the day of but prior to first dose of brentuximab vedotin).
  • Patient must not be pregnant and/or breastfeeding.
  • Patient must not be known to be HIV-positive on combination antiretroviral therapies.
  • Patient must not have had a previous allogeneic or syngeneic transplant. Prior autologous transplant is allowed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Pilot Study of Brentuximab Vedotin in the Prevention of Graft-Versus-Host Disease (GVHD) After Unrelated Allogeneic Stem Cell Transplantation

This pilot clinical trial studies the safety and maximum tolerated dose of brentuximab vedotin when given with tacrolimus and methotrexate after unrelated allogeneic donor stem cell transplant in patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes. The addition of brentuximab vedotin to tacrolimus and methotrexate may result in a significant reduction of graft versus host disease in these patients.

Being tested
brentuximab vedotin
Medical subject headings
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes

What participants receive

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

  • brentuximab vedotinDrug

    Also called Adcetris

Study groups in NCT01700751
Study groupRoleWhat they receive
Dose Level 0 (starting dose)Experimentalbrentuximab vedotin 0.3mg/kg, given IV on Days 7, 28, 49 \& 70
Receives: Drug: brentuximab vedotin
Dose Level 1Experimentalbrentuximab vedotin 0.6mg/kg, given IV on Days 7, 28, 49 \& 70
Receives: Drug: brentuximab vedotin
Dose Level 2Experimentalbrentuximab vedotin 1.2mg/kg, given IV on Days 7, 28, 49 \& 70
Receives: Drug: brentuximab vedotin
Dose Level 3Experimentalbrentuximab vedotin 1.8mg/kg, given IV on Days 7, 28, 49 \& 70
Receives: Drug: brentuximab vedotin
Control Dose LevelNo interventionThe first 3 patients will not receive brentuximab vedotin.

What is being measured

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

  1. MTD of brentuximab vedotin when administered with a GVHD prophylaxis regimen

    Defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity; Hematologic DLT is defined as ANC < 500/mm3 for three consecutive days beyond Day +21 that was determined by the investigator to be likely related to brentuximab vedotin.

    Non-hematologic DLT is defined as any grade 3 or higher non-hematologic toxicity that was determined by the investigator to be possibly, probably, or definitely related to brentuximab vedotin, with the following specific exceptions:

    • Grade 3 or 4 nausea, vomiting, diarrhea, mucositis, or fatigue thought to be associated with conditioning regimens
    • Grade 3 rash will only be considered a DLT for patients who have received two weeks of supportive care treatment with no improvement.

    Measured: 37 days

Secondary outcomes (9)

  1. Safety and tolerability of brentuximab vedotin when administered with a GVHD prophylaxis regimen

    Toxicities described and graded using CTCAE version 4.0; described by patient, type, and grade for each dose level; summarized by counts and percentage of patients in the corresponding categories

    Measured: 100 days

  2. Rate of acute GVHD

    Proportion of all subjects who experience symptoms consistent with grade 2-4 acute GVHD; using the standard grading system adapted from the Glucksberg clinical stage and grade of acute GVHD

    Measured: 100 days

  3. Rate of chronic GVHD

    Proportion of all subjects who experience symptoms consistent with chronic GVHD; assessment will begin after Day 100 using the NIH consensus criteria for diagnosis and staging of chronic GVHD

    Measured: 2 years

  4. Progression-free survival

    Duration from the time of transplant to time of first progression, death, relapse after complete response, or the date the patient was last known to be in remission; estimated with Kaplan-Meier methods.

    Measured: 2 years

  5. Overall survival.

    Duration from the time of transplant to death or last follow-up; estimated with Kaplan-Meier methods.

    Measured: 2 years

  6. 1-year non-relapse mortality rate

    Defined as the percentage of patients dying from etiologies other than disease relapse; estimated with Kaplan-Meier methods.

    Measured: 1 year

  7. 2-year non-relapse mortality rate

    Defined as the percentage of patients dying from etiologies other than disease relapse; estimated with Kaplan-Meier methods.

    Measured: 2 years

  8. 1-year disease relapse rate

    Defined as the percentage of patients who have disease relapse; estimated with Kaplan-Meier methods.

    Measured: 1 year

  9. 2-year disease relapse rate

    Defined as the percentage of patients who have disease relapse; estimated with Kaplan-Meier methods.

    Measured: 2 years

Timeline

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

  1. First posted4 Oct 2012 (estimated)
  2. Study start25 Feb 2013
  3. Primary completion11 Nov 2015
  4. Study completion21 Nov 2016

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01700751
Sponsor's protocol ID
201211047
Status last verified
Apr 2019
First submitted
18 Sep 2012
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing brentuximab vedotin in people with Leukemia, Acute Myeloid and Leukemia, Lymphoblastic,Acute, run by Washington University School of Medicine at 1 site 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 22 inclusion and 10 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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?

MTD of brentuximab vedotin when administered with a GVHD prophylaxis regimen (time frame: 37 days). 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 NCT01700751.

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 16 Apr 2019.

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