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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA069533 | U.S. NIH Grant/Contract | View source | |
| OHSU-HEM-04083-L | |||
| OHSU-IRB-248 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Chemotherapy, such as busulfan, melphalan, and thiotepa, may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving the patient their healthy stem cells will help their bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well busulfan, melphalan, and thiotepa work in treating patients who are undergoing an autologous stem cell transplant for Hodgkin's or non-Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE:
After completion of study treatment, patients are followed weekly for 1 month, monthly for 6 months, every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgrastim/Melphalan/Thiotepa | Experimental | Biological/Vaccine: filgrastim 5mcg/kg intravenous piggyback (IVPB) will be administered beginning on day +5 and continued until absolute neutrophil count (ANC) > 1500 for 2 consecutive days. Drug: busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours. Drug: melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml. Drug: thiotepa 250 mg/m2/day/iv on days -3 and -2 Procedure/Surgery: bone marrow ablation with stem cell support The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy. Procedure/Surgery: peripheral blood stem cell transplantation Performed 36-48 hours following last chemotherapy dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival | The data presented below represents the total number of subjects (out of 36) that reached disease-free survival status during Months 3, 6, 9, 12, 18, and 24 time points. | 3, 6, 9, 12, 18, and 24 months post transplantation |
| Therapy-Related Toxicities | The table presented below reflects how many participants (out of 36 total) presented an adverse event related to the treatment regimen within each toxicity category. To review specific adverse events, both related and unrelated to study treatment, please refer to Adverse Events Section. | Through 24 months post transplantation |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Intermediate- or high-grade non-Hodgkin's lymphoma (NHL), meeting 1 of the following criteria:
In first complete remission (CR) AND at high-risk for relapse, as defined by all of the following criteria:
High age-adjusted International Prognostic Index category AND meets the following criteria at diagnosis:
Mantle cell histology
Primary refractory disease
Beyond first CR
Low-grade NHL
Hodgkin's lymphoma
Must have an adequate number of stored autologous peripheral blood stem cells (PBSCs) (i.e., 2.0 x 10^6 hematopoietic progenitor cell antigen (CD34)-positive cells/kg)
No active CNS disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Richard Maziarz, MD | OHSU Knight Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Busulfan/Melphalan/Thiotepa | Treatment: Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours. Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml. Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2. Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose. The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy. Administration Growth Factor: Filgrastim 5mcg/kg intravenous piggyback (IVPB) will be administered beginning on day +5 and continued until absolute neutrophil count (ANC) > 1500 for 2 consecutive days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| busulfan | Drug | 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours. |
|
| melphalan | Drug | 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml. |
|
| thiotepa | Drug | 250 mg/m2/day/iv on days -3 and -2 |
|
| bone marrow ablation with stem cell support | Procedure | The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy. |
|
| peripheral blood stem cell transplantation | Procedure | Performed 36-48 hours following last chemotherapy dose. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Busulfan/Melphalan/Thiotepa | Treatment Plan: Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours. Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml. Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2. Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose. The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy. Administration Growth Factor: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disease-Free Survival | The data presented below represents the total number of subjects (out of 36) that reached disease-free survival status during Months 3, 6, 9, 12, 18, and 24 time points. | Posted | Count of Participants | Participants | 3, 6, 9, 12, 18, and 24 months post transplantation |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Therapy-Related Toxicities | The table presented below reflects how many participants (out of 36 total) presented an adverse event related to the treatment regimen within each toxicity category. To review specific adverse events, both related and unrelated to study treatment, please refer to Adverse Events Section. | Posted | Count of Participants | Participants | Through 24 months post transplantation |
|
|
For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BuMelTT | *For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported. TREATMENT PLAN: Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours. Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml. Thiotepa: 250 mg/m2/day/iv on days -3 and -2 Procedure/Surgery: bone marrow ablation with stem cell support The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy. Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose. Growth factor administration: Filgrastim | 36 | 36 | 36 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment | Unrelated to treatment regimen. |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Colonic obstruction | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | Unrelated to treatment regimen. |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Ileum obstruction | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | Related to treatment regimen. |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Influenza A | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Unrelated to treatment regimen. |
|
| Sepsis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Related to treatment regimen. |
|
| Vasovagal reaction | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment | Unrelated to treatment regimen. |
|
| Opioid overdose | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment | Unrelated to treatment regimen. |
|
| Suicide attempt | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment | Unrelated to treatment regimen. |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Distended abdomen | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | Related to treatment regimen. |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Auto GVHD | Immune system disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Clostridium difficile colitis (C. diff) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Entercolitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Related to treatment regimen. |
|
| Pancolitis | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Related to treatment regimen. |
|
| Abnormal ALT (alanine aminotransferase ) lab result | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Abnormal amylase lab result | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Muscle weakness (lower limb) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Eating disorder | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment | Unrelated to treatment regimen. |
|
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment | Unrelated to treatment regimen. |
|
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment | Unrelated to treatment regimen. |
|
| Bronchitis/early bronchopneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment | Related to treatment regimen. |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| General skin rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Unrelated to treatment regimen. |
|
| Thiotepa-induced skin rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Related to treatment regimen. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Maziarz, MD | Oregon Health & Science University | 503-494-6365 | maziarzr@ohsu.edu |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D002051 | Burkitt Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D012008 | Recurrence |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| 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 |
| D016393 | Lymphoma, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016399 | Lymphoma, T-Cell |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D002066 | Busulfan |
| D008558 | Melphalan |
| D013852 | Thiotepa |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| 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 |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Unknown or Not Reported |
|
| Title | Measurements |
|---|
|
| 12 months |
|
| 18 months |
|
| 24 months |
|
|