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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169505
Recruitment Status : Terminated (Slow Accrual)
First Posted : June 23, 2014
Results First Posted : May 17, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Brentuximab Vedotin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Brentuximab Vedotin Maintenance After Allogeneic and Haploidentical Stem Cell Transplantation in High Risk CD30+ Lymphoma (Hodgkin Lymphoma and ALCL)
Actual Study Start Date : May 22, 2015
Actual Primary Completion Date : August 14, 2017
Actual Study Completion Date : August 14, 2017


Arm Intervention/treatment
Experimental: Brentuximab Vedotin

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
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.
Other Names:
  • SGN-35
  • Adcetris




Primary Outcome Measures :
  1. Number of Participants With Secondary Graft Failure [ Time Frame: An average of 12 months ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Hematologic Toxicity [ Time Frame: an average of 12 months ]
    The most common grade > 3 side effects on Brentuximab.

  2. Number of Participants With Relapse [ Time Frame: an average of 12 months ]
    Evaluate the safety of brentuximab early after allogeneic stem cell transplant and haploidentical allogeneic transplantant and observe if there is a decrease in the risk of relapse.

  3. Number of Participants With Incidence of Cytomegalovirus (CMV) Reactivation and/or CMV Disease. [ Time Frame: an average of 12 months ]
    Evaluate the CMV in blood

  4. Number of Participants With Acute Graft-versus-host Disease (GVHD). [ Time Frame: an average of 12 months ]
    The tissue and serum in participants were measured by the GVHD

  5. Number of Participants With Central and Effector Cell Effects [ Time Frame: an average of 12 months ]
    We will perform on peripheral blood for mononuclear cells (PBMC) and serum collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as other immune subsets.

  6. Number of Participants With Change in Serum CD30 Levels After Brentuximab Administration [ Time Frame: an average of 12 months ]
    Immunological correlative studies on peripheral blood mononuclear cells (PBMC) and serum will be collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as CD30 levels.

  7. Number of Participants With Progression-Free Survival and Overall Survival on Brentuximab Maintenance [ Time Frame: an average of 12 months ]
    The Kaplan-Meier (1958) survival curves were used to estimate the overall survival and progression-free survival. Cox proportional hazards regression analysis was used to model the association between overall survival and progression-free survival and disease and demographic covariates of interest.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. Age 18 to 65 years.
  3. Performance status: Zubrod 0-1 or Karnofsky 80-100.
  4. 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).
  5. Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome).
  6. SGPT < 200 IU/L unless related to patient's malignancy.
  7. 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.
  8. Patients with previous exposure to brentuximab pre-transplant are eligible for the study.

Exclusion Criteria:

  1. 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.
  2. Presence of steroid-refractory acute graft-versus-host disease (GVHD).
  3. Patients that underwent allogeneic transplantation as a treatment of graft failure.
  4. Dual refractory CMV reactivation to foscarnet and ganciclovir or evidence of CMV disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169505


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Sairah Ahmed, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02169505    
Other Study ID Numbers: 2013-0351
NCI-2014-01593 ( Registry Identifier: NCI CTRP )
First Posted: June 23, 2014    Key Record Dates
Results First Posted: May 17, 2019
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
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
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases