Breast Cancer Clinical Trial
Official title:
A Phase II Study to Evaluate Low-Dose Alemtuzumab as a Glucocorticoid-Sparing Agent for Initial Systemic Treatment of Acute Graft-Versus-Host Disease
RATIONALE: Alemtuzumab and glucocorticoids, such as prednisone or methylprednisolone, may be
an effective treatment for acute graft-versus-host disease caused by a donor stem cell
transplant.
PURPOSE: This phase II trial is studying how well giving alemtuzumab together with
glucocorticoids works in treating newly diagnosed acute graft-versus-host disease in
patients who have undergone donor stem cell transplant.
OBJECTIVES:
- Determine whether the administration of low-dose alemtuzumab at the onset of acute
graft-versus-host disease can accelerate withdrawal of glucocorticoids and decrease
nonrelapsing mortality in patients who have undergone myeloablative allogeneic stem
cell transplantation.
OUTLINE: This is an open-label, nonrandomized study.
Within 72 hours of beginning glucocorticoid therapy, patients receive alemtuzumab IV over at
least 2 hours on days 1 and 2. If graft-versus-host disease (GVHD) responds well during days
1-14 but returns between days 28 and 56, patients are eligible to receive 2 additional doses
of alemtuzumab.
Patients receive glucocorticoid therapy comprising methylprednisolone IV or oral prednisone
daily until objective evidence of improvement in manifestations of GVHD. Patients with
resolved or significantly improved GVHD receive treatment until day 10 followed by an
accelerated taper until day 72 if no flare up of GVHD occurs during the glucocorticoid
taper. Patients with recurrent or progressive GVHD during the accelerated taper are treated
for 5-7 days before resuming a less rapid taper. Patients with no improvement may receive
secondary therapy with alternative immunosuppressive medications at the discretion of the
managing physician. Treatment continues in the absence of progressive GVHD of at least 3
days duration during days 2-10; persisting GVHD without improvement between days 10-14;
recurrent or progressive GVHD after day 10 that does not respond within 3 days to topical
immunosuppressive therapy; and/or an increase in the systemic glucocorticoid dose by two
taper steps; or unacceptable toxicity.
Patients undergo blood collection at baseline and then periodically during study treatment
for pharmacokinetics and quantification of viral loads for human herpes virus 6, adenovirus,
Epstein-Barr virus, and cytomegalovirus. Samples are also examined by flow cytometry for B-
and T-cell quantification at baseline, periodically during study treatment, and at 1 year
after transplantation.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |