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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00022 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride when given together with gemcitabine hydrochloride and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To evaluate the toxicity and determine the maximum tolerated dose (MTD) of combined bendamustine (bendamustine hydrochloride) and gemcitabine (gemcitabine hydrochloride) in patients with relapsed or refractory Hodgkin's lymphoma.
II. To determine the overall response rate of bendamustine and gemcitabine in patients with relapsed and refractory Hodgkin's lymphoma.
SECONDARY OBJECTIVES:
I. To determine whether therapy with bendamustine in the setting of relapsed or refractory Hodgkin's lymphoma will impact future stem cell collection.
OUTLINE: This is a phase I, dose-escalation study of bendamustine hydrochloride followed by a phase II study.
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1 and 2. Treatment repeats every 21-28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 2 years, then every 6 months for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (combination chemotherapy) | Experimental | Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1 and 2. Treatment repeats every 21-28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events in Terms of Dose-limiting Toxicity (DLT) and MTD of Bendamustine Hydrochloride (Phase I) | Dose limiting toxicity will be defined during cycle 1 only of the phase I trial. Hematologic and Infectious Dose Limiting Toxicities include: Grade 3 febrile neutropenia persisting> 7 days, Grade 4 infection or febrile neutropenia. Treatment delay>14 days due to grade 3-4 neutropenia or thrombocytopenia. Non-Hematological Dose Limiting Toxicities include: any Grade 3 or 4 non-hematologic toxicity related to study treatment with the exception of nausea or vomiting, alopecia, or electrolyte/glucose abnormalities that are correctable within 72 hours. | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) of Bendamustine Hydrochloride and Gemcitabine Hydrochloride in Patients With Relapsed or Refractory Hodgkin Lymphoma (Phase II) | Tested using Simon's two-stage Minimax design. Descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data) and graphical analyses will be used for all correlative laboratory parameters. The associations between correlative laboratory parameters and clinical response will be evaluated using two sample t test or Fisher's exact test, whichever is appropriate. |
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Inclusion Criteria:
Histologically documented Classical Hodgkin's lymphoma that is recurrent or refractory after standard chemotherapy; core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable
Patients with Hodgkin's lymphoma may have one of the following World Health Organization subtypes:
Patients must have relapsed or progressed after at least one prior therapy
Patients with relapsed or refractory disease following stem cell transplantation are permitted
No prior treatment with bendamustine; prior therapy with gemcitabine is permitted
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable
Measurable disease: lesions that can be accurately measured in at least two dimensions as >= 1.0 x 1.0 cm by computerized tomography (CT), PET/CT (positron emission tomography/CT), or magnetic resonance imaging (MRI)
Non-measurable disease: all other lesions, including small lesions (less than 1.0 x 1.0 cm) and truly non-measurable lesions; lesions that are considered non-measurable include the following:
Non-pregnant and non-nursing; due to the teratogenic potential of these agents, pregnant or nursing patients may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control
Patients with human immunodeficiency virus (HIV) infection are eligible; patients with HIV infection must meet the following: No evidence of co-infection with hepatitis B or C; cluster of differentiation (CD)4+ count >= 400/mm; no evidence of resistant strains of HIV; on anti-HIV therapy with an HIV viral load < 50 copies HIV ribonucleic acid (RNA)/mL; no history of acquired immune deficiency syndrome (AIDS) defining conditions
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| Name | Affiliation | Role |
|---|---|---|
| Beth Christian, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| Ohio State University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31821549 | Background | Cohen JB, Wei L, Maddocks KJ, Christian B, Heffner LT, Langston AA, Lechowicz MJ, Porcu P, Flowers CR, Devine SM, Blum KA. Gemcitabine and bendamustine is a safe and effective salvage regimen for patients with recurrent/refractory Hodgkin lymphoma: Results of a phase 1/2 study. Cancer. 2020 Mar 15;126(6):1235-1242. doi: 10.1002/cncr.32640. Epub 2019 Dec 10. |
| Label | URL |
|---|---|
| Jamesline | View source |
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The current study was conducted at the Ohio State University in Columbus, Ohio, and Emory University in Atlanta, Georgia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 (Dose Level 1) | Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2017 |
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| bendamustine hydrochloride | Drug | Given IV |
|
|
| up to 5 years |
| Columbus |
| Ohio |
| 43210 |
| United States |
| Phase 1 (Dose Level 2) |
Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| FG002 | Phase 1 (Dose Level 3) | Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| FG003 | Phase 1 (Dose Level 4) | Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| FG004 | Phase 2 (Dose Level 5) | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. |
| FG005 | Phase 2 | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 (Dose Levels 1) | Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV |
| BG001 | Phase 1 (Dose Levels 2) | Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| BG002 | Phase 1 (Dose Levels 3) | Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| BG003 | Phase 1 (Dose Levels 4) | Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| BG004 | Phase 2 (Dose Levels 5) | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. |
| BG005 | Phase 2 | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | patients |
|
| 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 | Adverse Events in Terms of Dose-limiting Toxicity (DLT) and MTD of Bendamustine Hydrochloride (Phase I) | Dose limiting toxicity will be defined during cycle 1 only of the phase I trial. Hematologic and Infectious Dose Limiting Toxicities include: Grade 3 febrile neutropenia persisting> 7 days, Grade 4 infection or febrile neutropenia. Treatment delay>14 days due to grade 3-4 neutropenia or thrombocytopenia. Non-Hematological Dose Limiting Toxicities include: any Grade 3 or 4 non-hematologic toxicity related to study treatment with the exception of nausea or vomiting, alopecia, or electrolyte/glucose abnormalities that are correctable within 72 hours. | Only patients in Phase I analyzed | Posted | Number | number of patients | up to 5 years |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) of Bendamustine Hydrochloride and Gemcitabine Hydrochloride in Patients With Relapsed or Refractory Hodgkin Lymphoma (Phase II) | Tested using Simon's two-stage Minimax design. Descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data) and graphical analyses will be used for all correlative laboratory parameters. The associations between correlative laboratory parameters and clinical response will be evaluated using two sample t test or Fisher's exact test, whichever is appropriate. | Only patients in Phase II analyzed | Posted | Number | percentage of patients | up to 5 years |
|
The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years.
The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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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 | Phase 1 (Dose Levels 1) | Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Phase 1 (Dose Levels 2) | Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | 0 | 3 | 3 | 3 | 3 | 3 |
| EG002 | Phase 1 (Dose Levels 3) | Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Phase 1 (Dose Levels 4) | Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | 0 | 4 | 4 | 4 | 4 | 4 |
| EG004 | Phase 2 (Dose Levels 5) | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. | 0 | 6 | 1 | 6 | 6 | 6 |
| EG005 | Phase 2 | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. | 0 | 7 | 1 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Kidney Disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Eye Pain | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Immune Systems Disorder | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection and Infestations | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Intraoperative urinary injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema face | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vascular disorders - Other, specify | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Beth Christian | The Ohio State University | 614-293-7807 | Beth.Christian@osumc.edu |
| Jan 19, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 |
| Phase 1 (Dose Levels 3) |
Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| OG003 | Phase 1 (Dose Levels 4) | Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| OG004 | Phase 2 (Dose Levels 5) | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. |
| OG005 | Phase 2 | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle |
|
|