Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SWS-SAKK-37/05 | |||
| EU-20648 | |||
| SPRI-SWS-SAKK-37/05 | |||
| CDR0000511915 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Giving chemotherapy drugs, such as melphalan, before an autologous stem cell transplant helps stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Also, monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Chemotherapy and monoclonal antibody therapy also prepares the patient's bone marrow for the stem cell transplant. Giving colony-stimulating factors, such as G-CSF, and vinorelbine helps stem cells move from the bone marrow to the blood so they can be collected and stored. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and monoclonal antibody therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of melphalan when given together with yttrium Y 90 ibritumomab tiuxetan and rituximab followed by autologous stem cell transplant in treating older patients with non-Hodgkin's lymphoma that has relapsed or not responded to previous treatment.
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of high-dose melphalan.
After completion of study treatment, patients are followed for 100 days.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zevalin, Rituximab, Melphalan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibritumomab tiuxetan | Drug | 185 MBq (5mCi) of 111In-Zevalin will be used for radioimaging. and the dose is 14.8 MBq/kg (0.4 mCi/kg) total body weight of 90Y-Zevalin (max. 1184 MBq or 32 mCi at patients > 80kg) for imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity of high-dose melphalan in combination with yttrium Y 90 ibritumomab tiuxetan | within 8 weeks after application of melphalan |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | 100 days (+/- 5 days) after reinfusion of stem cells | |
| Event occurrence up to 100 days after transplantation | up to 100 days after transplantation | |
| Complete remission 100 days after transplantation |
Not provided
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
WHO performance status 0-1
Bilirubin ≤ 2 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 2 times ULN
AST ≤ 2 times ULN
Creatinine clearance > 50 mL/min
No clinically significant cardiac disease, including any of the following:
LVEF > 50%
No clinically significant urinary tract obstruction
No clinically significant pulmonary disease
No serious underlying medical condition that would preclude study participation
No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated in situ cervical cancer
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michele Voegeli, MD | Kantonsspital Liestal | Study Chair |
| Michele Ghielmini, Prof | IOSI, Ospedale San Giovanni | Study Chair |
| Angelika Bischof Delaloye, Prof | Faculté de biologie et de médecine de l' Université de Lausanne | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Aarau | CH-5001 | Switzerland | |||
| Saint Claraspital AG |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27677906 | Result | Voegeli M, Rondeau S, Berardi Vilei S, Lerch E, Wannesson L, Pabst T, Rentschler J, Bargetzi M, Jost L, Ketterer N, Bischof Delaloye A, Ghielmini M. Y90 -Ibritumomab tiuxetan (Y90 -IT) and high-dose melphalan as conditioning regimen before autologous stem cell transplantation for elderly patients with lymphoma in relapse or resistant to chemotherapy: a feasibility trial (SAKK 37/05). Hematol Oncol. 2017 Dec;35(4):576-583. doi: 10.1002/hon.2348. Epub 2016 Sep 28. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| rituximab | Drug | 250 mg/m2 |
|
|
| melphalan | Drug |
|
|
|
| vinorelbine tartrate / G-CSF | Drug | on day 1: 35 mg/m2 day 4-8 (longer if required) G-CSF 5 μg/kg s.c. morning and 5 μg/kg s.c. evening for at least 5 days |
|
|
| autologous hematopoietic stem cell harvesting and transplantation | Procedure | Optimal mobilization usually takes place on day 8. A minimum of 2.5x106 CD34+ cells/kg should be collected (optimal 5x106 CD34+ cells/kg). If not enough CD34+ cells can be collected on day 8, it is recommended to continue with G-CSF until a sufficient collection (a minimum of 2.5x106 CD34+ cells/kg) can be obtained. Stem cells will be reinfused approximately 24 hours after the melphalan administration. The infusion will be performed with a minimum of 2.5x106 CD34+ cells/kg body weight according to local guidelines. G-CSF (5 μg/kg/d) will be given from day 5 and continued until neutrophils > 0.5x109/l for at least 2 consecutive days. |
|
| 100 days after transplantation |
| Basel |
| 4016 |
| Switzerland |
| Universitaetsspital-Basel | Basel | CH-4031 | Switzerland |
| Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli | Bellinzona | 6500 | Switzerland |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Kantonsspital Liestal | Bern | CH-3008 | Switzerland |
| Kantonsspital Bruderholz | Bruderholz | 4101 | Switzerland |
| Hopital Cantonal Universitaire de Geneve | Geneva | CH-1211 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C422802 | ibritumomab tiuxetan |
| D000069283 | Rituximab |
| D008558 | Melphalan |
| D000077235 | Vinorelbine |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided