Breast Cancer Clinical Trial
— Mini-alloOfficial title:
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation
NCT number | NCT01272817 |
Other study ID # | IRB#13-6255 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2001 |
Est. completion date | October 2015 |
Verified date | November 2022 |
Source | Scripps Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.
Status | Completed |
Enrollment | 36 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 72 Years |
Eligibility | Inclusion Criteria: 1. Age > 55 years or 2. Age < 55 and LVEF < 45% or creatinine clearance < 60 ml/min 3. Ability to cover the cost of the transplant, necessary medications, and transportation/housing. 4. Caregiver must be available while outpatient Guidelines for Cladribine-Melphalan-based conditioning: - Bone Marrow Failure States Severe Aplastic Anemia (relapsed following immunosuppressive therapy) Paroxysmal Nocturnal Hemoglobinuria (poor prognostic features or hemosiderosis) - AML (first CR except for t(15;17), inv16, t(8,21); second CR; relapse failing second induction attempt) - ALL (first CR with at least one poor prognostic feature; second or greater CR; relapse failing reinduction attempt) - MDS (RAEB, RAEBiT, CMMoL) - CML (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd chronic or accelerated phase following gleevec therapy - Hodgkin's lymphoma (first or greater relapse) - Non-Hodgkin's Lymphoma - Aggressive Histology (includes T Cell NHL) Incomplete response to induction Second CR Sensitive or refractory relapse - Indolent Histology Second or greater relapse - Mantle Cell Lymphoma (any Stage - must have received induction chemotherapy) - Multiple Myeloma (10% residual plasmacytosis following anthracycline-based chemotherapy or residual disease following autologous transplant) - Waldenstrom Macroglobulinemia (must have failed either purine analogue-based chemotherapy (Fludara or 2CdA) or standard CVP therapy; hyperviscosity or cytopenias) Guidelines for total lymphoid irradiation-based conditioning - MDS (RA, RARS) - CLL (Rai stage III or IV - must have received at least two different treatment regimens in the past) - Breast Cancer (symptomatic metastatic disease, who have failed standard chemotherapy) - Renal Cell Cancer (metastatic disease at multiple sites) - Malignant Melanoma (metastatic disease at multiple sites) - Sarcoma (all subtypes presently, unresectable metastatic disease) - Ovarian Cancer (stage III or IV, platinum insensitive disease, i.e. progression within 6 months of initial platinum chemotherapy) - Thymoma (unresectable disease) Exclusion Criteria: 1. Prior allogeneic stem cell or bone marrow transplant 2. Current or past history of invasive mycotic infection 3. Breast Feeding |
Country | Name | City | State |
---|---|---|---|
United States | Scripps Green Hospital | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
Scripps Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Engraftment | Evaluation of engraftment of donor stem cells by bone marrow examinations at days 30, 100, and 360 after transplant. | One year | |
Secondary | Graft-versus-host disease | Assess the incidence and severity of acute and/or chronic GVHD for patients transplanted on this protocol. | One year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
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 |
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 | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |