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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01798 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2012-0249 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I/II trial studies the best dose and side effects of gemcitabine and how well it works with clofarabine and busulfan and donor stem cell transplant in treating participants with chronic lymphocytic leukemia. Drugs used in chemotherapy, such as gemcitabine, clofarabine, and busulfan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of gemcitabine when administered with busulfan and clofarabine.
II. To estimate the day 100 treatment-related mortality (TRM) for the preparative regimen busulfan, clofarabine, and gemcitabine followed by allogeneic hematopoietic cell transplantation (HCT) for patients with chronic lymphocytic leukemia (CLL).
SECONDARY OBJECTIVES:
I. To determine the rate of progression-free survival (PFS), graft versus host disease (GVHD), engraftment, and overall survival (OS) for this treatment regimen at one year post treatment completion.
OUTLINE: This is a dose-escalation study of gemcitabine.
Participants receive gemcitabine intravenously (IV) over 10-25 minutes on days -6 and -4, clofarabine IV over 1 hour and busulfan IV over 3 hours on days -6 to -3. Participants with matched unrelated donors also receive anti-thymocyte globulin IV over 4 hours on days -3 to -1. Starting day -2, participants receive tacrolimus orally (PO) daily for up to 6 months. Participants undergo hematopoietic allogeneic stem cell transplant on day 0, then receive methotrexate IV over 15 minutes on days 1, 3, 6 and 11, and filgrastim subcutaneously (SC) once daily (QD) beginning 1 week after transplant until blood cell levels return to normal.
After completion of study treatment, participants are followed up at 3, 6 and 12 months, then every 6 months for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (combination chemotherapy, stem cell transplant) | Experimental | Participants receive gemcitabine IV over 10-25 minutes on days -6 and -4, clofarabine IV over 1 hour and busulfan IV over 3 hours on days -6 to -3. Participants with matched unrelated donors also receive anti-thymocyte globulin IV over 4 hours on days -3 to -1. Starting day -2, participants receive tacrolimus PO daily for up to 6 months. Participants undergo hematopoietic allogeneic stem cell transplant on day 0, then receive methotrexate IV over 15 minutes on days 1, 3, 6 and 11, and filgrastim SC QD beginning 1 week after transplant until blood cell levels return to normal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | Undergo stem cell transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 100 Day Treatment Related Mortality (TRM) | Number of deaths related to treatment by day 100 post allogeneic transplant | 100 days post transplant |
| Maximum Tolerated Dose (MTD) | To find the maximum tolerated dose (MTD) of Gemcitabine when administered with Busulfan & Clofarabine | Enrollment up to day 30 post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Will be estimated by the method of Kaplan and Meier. Time-to-event distributions as function of patient baseline covariates will be evaluated using Bayesian time-to-event regression modeling. | Up to 1 year post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Number of patients without any relapse post treatment completion | Up to 1 year post transplant |
| Time-to-engraftment | The number of days until participants by dose level reach engraftment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chitra Hosing | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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Participants enrolled at MD Anderson clinic starting on November 21, 2012 on Phase I of the study. No participants were enrolled on Phase II.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine Dose Level 1 | Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
| 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 | Sep 13, 2016 |
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| Anti-Thymocyte Globulin | Biological | Given IV |
|
|
| Busulfan | Drug | Given IV |
|
|
| Clofarabine | Drug | Given IV |
|
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| Filgrastim | Biological | Given SC |
|
|
| Gemcitabine | Drug | Given IV |
|
|
| Methotrexate | Drug | Given IV |
|
|
| Tacrolimus | Drug | Given PO |
|
|
| 30 days post transplant |
| Acute and Chronic Graft Verse Host Disease (GvHD) | GvHD (Graft versus Host Disease) occurs when immune cells transplanted from a non-identical donor (graft) recognizes the transplant recipient (the host) as foreign, thereby initiating an immune reaction in the transplant recipient. Acute GvHD typically occurs around the time of engraftment and manifests in skin, GI system, and liver abnormalities. Chronic GvHD is defined by manifestations such as ocular, oral, lung, sclerosis skin, failure to thrive, fascia, cholestasis in liver, esophagus strictures. | Up to 1 year post transplant |
| Gemcitabine Dose Level 2 |
Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
| FG002 | Gemcitabine Dose Level 3 | Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
| FG003 | Gemcitabine Dose Level 4 | Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
| COMPLETED |
|
| NOT COMPLETED |
|
Patients age 18-70 with CLL, PLL, or Richter's Transformation who were eligible for allogeneic transplantation
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine Dose Level 1 | Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
| BG001 | Gemcitabine Dose Level 2 | Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
| BG002 | Gemcitabine Dose Level 3 | Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
| BG003 | Gemcitabine Dose Level 4 | Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | 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 | Count of Participants | Participants |
| ||||||||||||||||
| Disease Category | Count of Participants | Participants |
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| 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 | 100 Day Treatment Related Mortality (TRM) | Number of deaths related to treatment by day 100 post allogeneic transplant | No participants were treated at dose level 2. | Posted | Count of Participants | Participants | No | 100 days post transplant |
|
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| ||||||||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose (MTD) | To find the maximum tolerated dose (MTD) of Gemcitabine when administered with Busulfan & Clofarabine | MTD analysis was for Phase II. Data were not collected. | Posted | Enrollment up to day 30 post transplant |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Will be estimated by the method of Kaplan and Meier. Time-to-event distributions as function of patient baseline covariates will be evaluated using Bayesian time-to-event regression modeling. | All participants were registered on Phase I. | Posted | Count of Participants | Participants | No | Up to 1 year post transplant |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Progression-free Survival (PFS) | Number of patients without any relapse post treatment completion | Analysis was for Phase II. No analysis was done due to low accrual on Phase I. | Posted | No | Up to 1 year post transplant |
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time-to-engraftment | The number of days until participants by dose level reach engraftment. | No participants were treated at dose level 2. | Posted | Number | participants | 30 days post transplant |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Acute and Chronic Graft Verse Host Disease (GvHD) | GvHD (Graft versus Host Disease) occurs when immune cells transplanted from a non-identical donor (graft) recognizes the transplant recipient (the host) as foreign, thereby initiating an immune reaction in the transplant recipient. Acute GvHD typically occurs around the time of engraftment and manifests in skin, GI system, and liver abnormalities. Chronic GvHD is defined by manifestations such as ocular, oral, lung, sclerosis skin, failure to thrive, fascia, cholestasis in liver, esophagus strictures. | Analysis was for Phase II. No analysis was done due to low accrual on Phase I. | Posted | No | Up to 1 year post transplant |
|
Up to 100 Days post transplant
At Gemcitabine Dose Level 2, there were no participants at that dose level and so the number of participants at risk for adverse events is zero.
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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 | Gemcitabine Dose Level 1 | Gemcitabine 100 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant | 1 | 4 | 0 | 4 | 4 | 4 |
| EG001 | Gemcitabine Dose Level 2 | Gemcitabine 150 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Gemcitabine Dose Level 3 | Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant | 1 | 8 | 0 | 8 | 8 | 8 |
| EG003 | Gemcitabine Dose Level 4 | Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant | 1 | 3 | 0 | 3 | 3 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Fluid Overload | General disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Elevated Creatinine | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Hemorrhagic Cystitis | Renal and urinary disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Transaminitis | Hepatobiliary disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Elevated Bilirubin | Hepatobiliary disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE v3.0 | Systematic Assessment |
| |
| Neutropenic Fever | General disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Headaches | Nervous system disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Skin Rash | Skin and subcutaneous tissue disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Acute Graft versus Host Disease | General disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Chronic Graft versus Host Disease | General disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Secondary Graft Failure | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment |
| |
| Primary Graft Failure | Blood and lymphatic system disorders | CTCAE v3.0 | Systematic Assessment |
|
Early termination leading to small number of subjects analyzed. This study never moved to Phase II, therefore was not analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chitra Hosing | UT MD Anderson Cancer Center | 713-792-8750 | cmhosing@mdanderson.org |
| Mar 27, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015463 | Leukemia, Prolymphocytic |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D002066 | Busulfan |
| D000077866 | Clofarabine |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000093542 | Gemcitabine |
| D008727 | Methotrexate |
| C015342 | merphos |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| 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 |
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D018942 | Macrolides |
| D007783 | Lactones |
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| Between 18 and 65 years |
|
| >=65 years |
|
| 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 |
|
| Diseases : Prolymphocytic Leukemia (PLL) |
|
| Diseases: Richter's |
|
| Graft versus Host Disease (GVHD) |
|
| OG003 | Gemcitabine Dose Level 4 | Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
|
| OG003 | Gemcitabine Dose Level 4 | Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
|
|
| OG003 |
| Gemcitabine Dose Level 4 |
Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
|
| OG003 |
| Gemcitabine Dose Level 4 |
Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
|
|
Gemcitabine 200 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
| OG003 | Gemcitabine Dose Level 4 | Gemcitabine 250 mg/m2 IV preceded by loading dose of 75 mg/m2 for 2 days + Busulfan(adjusted Pharmacokinetic dosing) IV for 4 days + Clofarabine 30 mg/m2 IV for 4 days + Thymoglobulin 4mg/kg(Matched Unrelated Donor patients only) IV for 3 days + Stem Cell Transplant |
|
|