Clinical trial NCT02169505: Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Study Drug Administration:

If you agree to take part in this study, about 35-60 days after the transplant, you will receive brentuximab vedotin by vein over about 30 minutes on Day 1 of each 21-day study cycle. You may receive up to 6 cycles of brentuximab vedotin.

At Cycles 3 and beyond, you will receive a higher dose of the study drug than you received during Cycles 1 and 2.

Study Visits:

About 5 days before Day 1 of Cycle 1:

* You will have a physical exam. As part of the physical exam, you will be checked for graft-versus-host disease (GVHD -- when transplanted donor tissue attacks the tissues of the recipient's body). You may have an additional blood draw to check for GVHD as part of your standard of care.
* Blood (about 2 tablespoons) will be drawn for routine tests and to check how the transplant has taken.
* Blood (about 2 teaspoons each time) will be drawn before and after your dose of study drug to check the immune system.

On Days 3 and 5 of Cycle 1, blood (about 2 teaspoons) will be drawn to check the immune system.

About 5 days before Day 1 of Cycles 2-6:

* You will have a physical exam.
* Blood (about 2 tablespoons) will be drawn for routine tests and to check the immune system.

If your doctor thinks it is needed, you may have a skin biopsy or endoscopy to check for GVHD and/or graft failure. You will sign a separate consent form that explains the procedures and risks.

Length of Study:

You will be taken off study 1 year after the transplant. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if you develop an infection (such as cytomegalovirus \[CMV\] that does not respond to treatment), or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Follow-Up Visits:

About 1, 3, 6, and 12 months after the transplant, you will have follow-up visits as part of your standard of care after your transplant. At these visits:

* You will have a physical exam
* Blood (about 4 tablespoons) will be drawn for routine tests, to learn how the transplant has taken, and to check the status of the disease.
* You will have a computed tomography (CT) scan to check the status of the disease.
* You will have a bone marrow biopsy and aspiration to check the status of the disease and for cytogenetic testing. To collect a bone marrow biopsy/aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Cytogenetic testing looks at how genetic changes to cells may affect how the disease may react to the study drug.

This is an investigational study. Brentuximab vedotin is FDA approved and commercially available for the treatment of Hodgkin lymphoma and ALCL. It is investigational to give brentuximab vedotin at an earlier time after a transplant.

Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Secondary Graft Failure
timeFrame: An average of 12 months
Secondary outcomes:
measure: Number of Participants With Hematologic Toxicity
timeFrame: an average of 12 months
measure: Number of Participants With Relapse
timeFrame: an average of 12 months
measure: Number of Participants With Incidence of Cytomegalovirus (CMV) Reactivation and/or CMV Disease.
timeFrame: an average of 12 months
measure: Number of Participants With Acute Graft-versus-host Disease (GVHD).
timeFrame: an average of 12 months
measure: Number of Participants With Central and Effector Cell Effects
timeFrame: an average of 12 months
measure: Number of Participants With Change in Serum CD30 Levels After Brentuximab Administration
timeFrame: an average of 12 months
measure: Number of Participants With Progression-Free Survival and Overall Survival on Brentuximab Maintenance
timeFrame: an average of 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sairah Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: