Mast Cell Leukemia Clinical Trial
Official title:
A Study of Brentuximab Vedotin (SGN-35) in CD30-Positive Systemic Mastocytosis With or Without an Associated Hematological Clonal Non-Mast Cell Lineage Disease (AHNMD)
This pilot clinical trial studies brentuximab vedotin in treating patients with advanced systemic mastocytosis or mast cell leukemia. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them
Brentuximab vedotin is an antibody with a covalently attached toxin. The antibody portion
targets the protein CD30 on the surface of cells, and the toxin acts against those cells.
PRIMARY OBJECTIVES:
I. To evaluate the response rate to SGN-35 (brentuximab vedotin) in patients with tumor
necrosis factor receptor superfamily, member 8 (CD30+) advanced systemic mastocytosis (SM)
(ASM or mast cell leukemia [MCL] with or without an associated hematological clonal non-mast
cell lineage disease [AHNMD]).
SECONDARY OBJECTIVES:
I. To evaluate the tolerability and safety profile of SGN-35 in patients with SM.
II. To evaluate expression of CD30 on neoplastic mast cells before and during therapy with
SGN-35.
III. To evaluate changes in mastocytosis related symptom scores and quality of life (QOL)
using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPNSAF).
IV. To evaluate the duration of response (DoR) and time to response (TTR). V. To evaluate
progression-free survival (PFS).
OUTLINE:
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment
repeats every 21 days for 8 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up every 6 weeks for 1 year and
then every 12 weeks thereafter.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00387426 -
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
|
Phase 2 | |
| Completed |
NCT00898079 -
Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer
|
||
| Active, not recruiting |
NCT03580655 -
(PATHFINDER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis
|
Phase 2 | |
| Completed |
NCT00112593 -
Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer
|
N/A | |
| Completed |
NCT00006251 -
Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine, Mycophenolate Mofetil, Donor Lymphocyte Infusion in Treating Patients With Hematopoietic Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT02415608 -
Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis
|
Phase 2 | |
| Active, not recruiting |
NCT00118352 -
Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
|
Phase 2 | |
| Completed |
NCT02561988 -
(EXPLORER) Study of BLU-285 in Patients With Advanced Systemic Mastocytosis (AdvSM) and Relapsed or Refractory Myeloid Malignancies
|
Phase 1 | |
| Completed |
NCT01869777 -
Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia
|
N/A | |
| Completed |
NCT01231919 -
MK2206 in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Leukemia
|
Phase 1 | |
| Completed |
NCT01273766 -
Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies
|
Phase 2 | |
| Terminated |
NCT03214666 -
GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT01199562 -
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
|
||
| Completed |
NCT00014235 -
Fludarabine Phosphate and Total-Body Radiation Followed by Donor Peripheral Blood Stem Cell Transplant and Immunosuppression in Treating Patients With Hematologic Malignancies
|
N/A | |
| Completed |
NCT04695431 -
Retrospective Study Assessing the Effect of Avapritinib Versus Best Available Therapy in Patients With AdvSM
|
||
| Completed |
NCT00890747 -
Sunitinib Malate in Treating HIV-Positive Patients With Cancer Receiving Antiretroviral Therapy
|
Phase 1 | |
| Completed |
NCT01053494 -
Massage Therapy Given by Caregiver in Treating Quality of Life of Young Patients Undergoing Treatment for Cancer
|
N/A | |
| Available |
NCT05219266 -
Managed Access Programs for PKC412, Midostaurin
|