Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT)

NCT02169505 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 2013-0351NCI-2014-01593
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to study the safety of ADCETRISTM (brentuximab vedotin) in patients with Hodgkin lymphoma or ALCL who have had an allogeneic or haploidentical stem cell transplant. Another goal of this study is to learn if brentuximab vedotin can help to prevent the disease from coming back.

Conditions

Lymphoma

Keywords

Lymphoma; Hodgkin lymphoma; HL; CD30 positive Hodgkin Lymphoma; Anaplastic large cell lymphoma; ALCL; Allogeneic Stem Cell Transplantation; ASCT; Graft-versus-host disease; GVHD; Brentuximab Vedotin; SGN-35; Adcetris

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Secondary Graft Failure

  Safety is defined by no more than two secondary graft failures within 6 months of transplant (Day 0), based on an observed graft failure rate of \<10% using standard of care treatment. If at any time more than two of these events are observed during the specified time frame, the study will be stopped and no further patients will be accrued.

  An average of 12 months

Secondary Outcomes (7)

• Number of Participants With Hematologic Toxicity

  an average of 12 months

• Number of Participants With Relapse

  an average of 12 months

• Number of Participants With Incidence of Cytomegalovirus (CMV) Reactivation and/or CMV Disease.

  an average of 12 months

• Number of Participants With Acute Graft-versus-host Disease (GVHD).

  an average of 12 months

• Number of Participants With Central and Effector Cell Effects

  an average of 12 months

Study Arms (1)

Brentuximab Vedotin

EXPERIMENTAL

Brentuximab by vein over 30 minutes every 3 weeks for a total of 6 cycles starting between days 30 and 60 post allogeneic stem cell transplant (SCT). Brentuximab dose based on actual body weight starting with an initial dose of 1.2 mg/kg for the first 2 cycles and dose increased to 1.8 mg/kg after the second cycle for all subsequent cycles.

Drug: Brentuximab Vedotin

Interventions

Brentuximab Vedotin DRUG

Starting dose: 1.2 mg/kg by vein on Day 1 for the first 2, 21 day cycles. Dose increased to 1.8 mg/kg by vein after the second cycle for all subsequent cycles.

Also known as: SGN-35, Adcetris

Brentuximab Vedotin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with CD30 positive Hodgkin Lymphoma (HL) or anaplastic large cell lymphoma (ALCL) that have undergone allogeneic or haploidentical SCT in the past 60 days (matched related or matched unrelated donors only).
• Age 18 to 65 years.
• Performance status: Zubrod 0-1 or Karnofsky 80-100.
• Serum creatinine \< 1.5 mg/dL or creatinine clearance greater than or equal to 40 cc/min as defined by MDRD method from National Kidney Disease Education Program (NKDEP).
• Serum direct bilirubin \< 1.5 mg/dL (unless Gilbert's syndrome).
• SGPT \< 200 IU/L unless related to patient's malignancy.
• Evidence of neutrophil and platelet engraftment, defined as platelet count equal or greater than 50,000 mm3 independent of platelet transfusion and ANC equal or greater to 1000 without growth factor support for at least 5 days.
• Patients with previous exposure to brentuximab pre-transplant are eligible for the study.

You may not qualify if:

• Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is post-menopausal with a positive serum pregnancy test.
• Presence of steroid-refractory acute graft-versus-host disease (GVHD).
• Patients that underwent allogeneic transplantation as a treatment of graft failure.
• Dual refractory CMV reactivation to foscarnet and ganciclovir or evidence of CMV disease.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic; Graft vs Host Disease

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Ahmed,Sairah,MD / Stem Cell Transplantation
• Organization: UT MD Anderson Cancer Center

sahmed3@mdanderson.org

713-792-7734

Study Officials

• Sairah Ahmed, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 23, 2014
• Study Start: May 22, 2015
• Primary Completion: August 14, 2017
• Study Completion: August 14, 2017
• Last Updated: November 27, 2019
• Results First Posted: May 17, 2019

Record last verified: 2019-11

Locations

US (1)