<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02211755</url>
  </required_header>
  <id_info>
    <org_study_id>140161</org_study_id>
    <secondary_id>14-C-0161</secondary_id>
    <nct_id>NCT02211755</nct_id>
  </id_info>
  <brief_title>Trial of the Combination of Bortezomib and Clofarabine in Adults With Relapsed Solid Tumors</brief_title>
  <official_title>Phase I Trial of the Combination of Bortezomib and Clofarabine in Adults With Refractory Solid Tumors, Lymphomas, or Myelodysplastic Syndromes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - Researchers want to develop better ways to treat cancer. In this study, they will give&#xD;
      people with cancer two drugs. These drugs have been used on their own to treat some blood&#xD;
      cell cancers.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      - To test the safety and efficacy of the drug combination of bortezomib and clofarabine.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Adults age 18 and over with advanced cancer that has progressed after receiving standard&#xD;
      treatment or that has no effective therapy.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be screened with medical history, physical exam, and scans to measure&#xD;
           their tumors. They will also have heart, blood, and urine tests. All of these may be&#xD;
           done by their regular doctors.&#xD;
&#xD;
        -  Participants will get the study drugs in 21-day cyles. They will stay at the clinic for&#xD;
           week 1 of every cycle, then have 2 weeks off.&#xD;
&#xD;
      &lt;TAB&gt;- Bortezomib will be injected under the skin on days 1 and 4.&#xD;
&#xD;
      &lt;TAB&gt;- Clofarabine will be injected in a vein for days 1-5.&#xD;
&#xD;
        -  During cycle 1 only, participants will go to the clinic or their doctor to have a&#xD;
           physical exam and blood tests at the start of the second and third week.&#xD;
&#xD;
        -  Participants will have clinical evaluations throughout the study, including before&#xD;
           receiving treatment and then before the start of each cycle.&#xD;
&#xD;
        -  Participants may stay in the study as long as they are tolerating the drugs and their&#xD;
           tumor is not getting worse.&#xD;
&#xD;
        -  Participants will have follow-up for 30 days after the last dose of study drugs.&#xD;
&#xD;
        -  The first part of this study tests the safety of different doses of clofarabine and&#xD;
           bortezomib.&#xD;
&#xD;
        -  The second part of this study involves a separate group of participants who will undergo&#xD;
           mandatory research biopsies to learn more about the effects of clofarabine and&#xD;
           bortezomib on cancer cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND:&#xD;
&#xD;
      The proteasome inhibitor bortezomib and purine nucleoside metabolic inhibitor clofarabine&#xD;
      demonstrated greater than additive activity in combination in preclinical xenograft models,&#xD;
      justifying the clinical evaluation of this combination for its antitumor activity&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
      To establish the safety, tolerability, and maximum tolerated dose (MTD) of bortezomib and&#xD;
      clofarabine in patients with refractory solid tumors, lymphomas, or myelodysplastic syndromes&#xD;
      (MDS)&#xD;
&#xD;
      To determine the molecular effects of the clofarabine-bortezomib combination on biomarkers of&#xD;
      cell death and DNA damage in tumor biopsy tissue&#xD;
&#xD;
      To explore the mechanism of action of the bortezomib and clofarabine combination by examining&#xD;
      markers of DNA damage and apoptosis in circulating tumor cells before and after treatment&#xD;
&#xD;
      To characterize the changes in MDS residual disease burden that occur with bortezomib and&#xD;
      clofarabine treatment&#xD;
&#xD;
      To examine genomic alterations in circulating tumor DNA (ctDNA) that may be associated with&#xD;
      response or resistance to clofarabine-bortezomib combination treatment.&#xD;
&#xD;
      ELIGIBILITY:&#xD;
&#xD;
        -  Study participants must have histologically confirmed solid tumors or lymphomas or&#xD;
           myelodysplastic syndromes that have progressed on standard therapy known to prolong&#xD;
           survival or for which no standard treatment options exist&#xD;
&#xD;
        -  Age greater than or equal to 18&#xD;
&#xD;
        -  No major surgery, radiation, or chemotherapy within 3 weeks prior to entering the study&#xD;
&#xD;
        -  Adequate organ function&#xD;
&#xD;
      STUDY DESIGN:&#xD;
&#xD;
        -  This is an open-label Phase I trial&#xD;
&#xD;
        -  The starting dose of clofarabine will be 1 mg/m2 administered intravenously on days 1&#xD;
           through 5 of a 21-day cycle; bortezomib will be administered at 0.8 mg/m2 subcutaneously&#xD;
           on days 1 and 4 of a 21-day cycle.&#xD;
&#xD;
        -  Dose escalation will follow a 3+3 design, with dose limiting toxicities defined during&#xD;
           cycle 1.&#xD;
&#xD;
        -  Dose escalation will proceed in cohorts comprised of two separate groups of patients&#xD;
           (one group of patients with solid tumor/lymphoma and one group of patients with MDS),&#xD;
           with at least 1 from each group, until hematologic DLT or the second grade 2 hematologic&#xD;
           toxicity is observed, at which point, dose escalation will proceed separately for two&#xD;
           cohorts: (1) patients with solid tumors/lymphoma and (2) patients with MDS.&#xD;
&#xD;
        -  Up to 33 patients will be accrued to a PD expansi n cohort at the MTD to further assess&#xD;
           pharmacodynamic endpoints in tumor and blood.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 6, 2014</start_date>
  <completion_date type="Anticipated">December 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and MTD</measure>
    <time_frame>Cycle 1 (21 days)</time_frame>
    <description>To establish the safety, tolerability, and maximum tolerated dose (MTD) of bortezomib and clofarabine in patients with refractory solid tumors or lymphomas or myelodysplastic syndromes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of DNA damage and apoptosis in circulating tumor cells</measure>
    <time_frame>Baseline, cycle 1 day 1, and cycle 2 day 1</time_frame>
    <description>To determine the effects of the clofarabine-bortezomib combination on biomarkers of DNA damage and apoptosis in circulating tumor cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of cell death and DNA damage in tumor biopsy tissue</measure>
    <time_frame>Baseline, cycle 1 day 1, and cycle 2 day 4/day 5</time_frame>
    <description>To determine the effects of the clofarabine-bortezomib combination on biomarkers of cell death and DNA damage in tumor biopsy tissue</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Neoplasms</condition>
  <condition>Myelodysplastic Syndromes</condition>
  <condition>Lymphomas</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Starting doses are clofarabine at 1 mg/m2 IV on days 1 through 5 of a 21-day cycle, and bortezomib at 0.8 mg/m2 subcutaneously on days 1 and 4 of a 21-day cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bortezomib plus Clofarabine</intervention_name>
    <description>The proteasome inhibitor bortezomib and purine nucleoside metabolic inhibitor clofarabine demonstrated greater than additive activity in combination in preclinical xenograft models</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -INCLUSION CRITERIA&#xD;
&#xD;
          1. Patients must have:&#xD;
&#xD;
               -  Histologically confirmed solid tumors that have progressed on standard therapy&#xD;
                  known to prolong survival or for which no standard treatment options exist, or&#xD;
&#xD;
               -  histologically confirmed myelodysplastic syndrome that has progressed on standard&#xD;
                  therapy or for which no standard treatment options exist. (As of Amendment L,&#xD;
                  January 2021, the MDS cohort has been closed due to low accrual.)&#xD;
&#xD;
          2. Age greater than or equal to18 years.&#xD;
&#xD;
          3. ECOG performance status less than or equal to 2.&#xD;
&#xD;
          4. Life expectancy of greater than 3 months&#xD;
&#xD;
          5. Patients must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  Absolute neutrophil count: greater than or equal to 1,500/mcL for solid tumors&#xD;
                  and lymphomas only&#xD;
&#xD;
               -  Platelets: greater than or equal to 100,000/mcL for solid tumors and lymphomas&#xD;
                  only&#xD;
&#xD;
               -  Total bilirubin: less than or equal to 1.5 X institutional ULN (&lt;=3 x upper limit&#xD;
                  of normal in the presence of documented Gilbert's syndrome or liver metastases at&#xD;
                  baseline)&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT): less than or equal to 3 X institutional upper limit of&#xD;
                  normal&#xD;
&#xD;
             OR&#xD;
&#xD;
             less than 5 X institutional upper limit of normal for&#xD;
&#xD;
             -creatinine: ess than or equal to 1.5 X institutional ULN&#xD;
&#xD;
             OR&#xD;
&#xD;
             creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with&#xD;
             creatinine levels &gt;1.5 mg/dL&#xD;
&#xD;
          6. Bortezomib and clofarabine have both been assigned to pregnancy category D by the FDA.&#xD;
             For this reason, women of child-bearing potential and men must agree to use adequate&#xD;
             contraception (hormonal or barrier method of birth control; abstinence) prior to study&#xD;
             entry and for the duration of study participation and for at least 3 months after&#xD;
             dosing with study drugs ceases. Should a woman become pregnant or suspect she is&#xD;
             pregnant while she or her partner is participating in this study, she should inform&#xD;
             her treating physician immediately. Men treated or enrolled on this protocol must also&#xD;
             agree to use adequate contraception prior to the study, for the duration of study&#xD;
             participation, and 3 months after completion of study drug administration.&#xD;
&#xD;
          7. Patients must have completed any chemotherapy, radiation therapy, or biologic therapy&#xD;
             &gt;= 3 weeks (or &gt;= 5 half-lives, whichever is shorter) prior to entering the study.&#xD;
             Patients must be &gt;= 2 weeks since any prior administration of a study drug in a Phase&#xD;
             0 or equivalent study and be &gt;= 1 week from palliative radiation therapy (patients on&#xD;
             study may be eligible for palliative radiotherapy to non-targeted lesions after 2&#xD;
             cycles of therapy at the PI s discretion). Patients must have recovered to eligibility&#xD;
             levels from prior toxicity or adverse events. Treatment with bisphosphonates is&#xD;
             permitted.&#xD;
&#xD;
          8. For patients enrolled on the expansion cohort, patients must have tumor amenable to&#xD;
             biopsy (excisional or incision biopsies of skin or H &amp; N lesions under visualization)&#xD;
             and willingness to undergo tumor biopsies.&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          1. Sensory/motor neuropathy &gt;= Grade 2&#xD;
&#xD;
          2. QTc interval (Fridericia formula) &gt; 450 msec for men or &gt; 470 msec for women at study&#xD;
             entry; history of congenital long QT syndrome&#xD;
&#xD;
          3. Patients who are receiving any other investigational agents.&#xD;
&#xD;
          4. Patients with active brain metastases, CNS disease, or carcinomatous meningitis are&#xD;
             excluded from this clinical trial. Patients with treated brain metastases are eligible&#xD;
             if follow-up brain imaging after central nervous system (CNS)-directed therapy shows&#xD;
             no&#xD;
&#xD;
             evidence of progression.&#xD;
&#xD;
          5. History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to study drugs. Patients who have previously received either clofarabine&#xD;
             or bortezomib will be excluded as this may affect accurate determination of the MTD.&#xD;
&#xD;
          6. Uncontrolled intercurrent illness including, but not limited to, serious untreated&#xD;
             infection, symptomatic respiratory failure/congestive heart failure, unstable angina&#xD;
             pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would&#xD;
             limit compliance with study requirements.&#xD;
&#xD;
          7. Pregnant women are excluded from this study because bortezomib and clofarabine have&#xD;
             been assigned to pregnancy category D by the FDA. Because there is an unknown but&#xD;
             potential risk for adverse events in nursing infants secondary to treatment of the&#xD;
             mother with the study drugs, breastfeeding should be discontinued prior to the first&#xD;
             dose of study drug and women should refrain from nursing throughout the treatment&#xD;
             period and for 3 months following the last dose of study drug.&#xD;
&#xD;
          8. HIV-positive patients on combination antiretroviral therapy are ineligible because of&#xD;
             possible pharmacokinetic interactions with study drugs.&#xD;
&#xD;
          9. Both men and women of all races and ethnic groups are eligible for this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naoko Takebe, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Murielle Hogu</last_name>
    <phone>(240) 858-3335</phone>
    <email>murielle.hogu@nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Naoko Takebe, M.D.</last_name>
    <phone>(240) 541-4515</phone>
    <email>takeben@mail.nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2014-C-0161.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Duechler M, Linke A, Cebula B, Shehata M, Schwarzmeier JD, Robak T, Smolewski P. In vitro cytotoxic effect of proteasome inhibitor bortezomib in combination with purine nucleoside analogues on chronic lymphocytic leukaemia cells. Eur J Haematol. 2005 May;74(5):407-17. doi: 10.1111/j.1600-0609.2004.00406.x.</citation>
    <PMID>15813915</PMID>
  </reference>
  <reference>
    <citation>Kummar S, Chen HX, Wright J, Holbeck S, Millin MD, Tomaszewski J, Zweibel J, Collins J, Doroshow JH. Utilizing targeted cancer therapeutic agents in combination: novel approaches and urgent requirements. Nat Rev Drug Discov. 2010 Nov;9(11):843-56. doi: 10.1038/nrd3216. Epub 2010 Oct 29.</citation>
    <PMID>21031001</PMID>
  </reference>
  <verification_date>January 21, 2023</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Purine Nucleoside Inhibitor</keyword>
  <keyword>Proteasome Inhibitor</keyword>
  <keyword>Combination Treatment</keyword>
  <keyword>Solid Tumors</keyword>
  <keyword>Hematologic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bortezomib</mesh_term>
    <mesh_term>Clofarabine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02211755
org study id: 140161
secondary id: 14-C-0161
nct id: NCT02211755
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Background:

      - Researchers want to develop better ways to treat cancer. In this study, they will give
      people with cancer two drugs. These drugs have been used on their own to treat some blood
      cell cancers.

      Objectives:

      - To test the safety and efficacy of the drug combination of bortezomib and clofarabine.

      Eligibility:

      - Adults age 18 and over with advanced cancer that has progressed after receiving standard
      treatment or that has no effective therapy.

      Design:

        -  Participants will be screened with medical history, physical exam, and scans to measure
           their tumors. They will also have heart, blood, and urine tests. All of these may be
           done by their regular doctors.

        -  Participants will get the study drugs in 21-day cyles. They will stay at the clinic for
           week 1 of every cycle, then have 2 weeks off.

      <TAB>- Bortezomib will be injected under the skin on days 1 and 4.

      <TAB>- Clofarabine will be injected in a vein for days 1-5.

        -  During cycle 1 only, participants will go to the clinic or their doctor to have a
           physical exam and blood tests at the start of the second and third week.

        -  Participants will have clinical evaluations throughout the study, including before
           receiving treatment and then before the start of each cycle.

        -  Participants may stay in the study as long as they are tolerating the drugs and their
           tumor is not getting worse.

        -  Participants will have follow-up for 30 days after the last dose of study drugs.

        -  The first part of this study tests the safety of different doses of clofarabine and
           bortezomib.

        -  The second part of this study involves a separate group of participants who will undergo
           mandatory research biopsies to learn more about the effects of clofarabine and
           bortezomib on cancer cells.
BACKGROUND:

      The proteasome inhibitor bortezomib and purine nucleoside metabolic inhibitor clofarabine
      demonstrated greater than additive activity in combination in preclinical xenograft models,
      justifying the clinical evaluation of this combination for its antitumor activity

      OBJECTIVES:

      To establish the safety, tolerability, and maximum tolerated dose (MTD) of bortezomib and
      clofarabine in patients with refractory solid tumors, lymphomas, or myelodysplastic syndromes
      (MDS)

      To determine the molecular effects of the clofarabine-bortezomib combination on biomarkers of
      cell death and DNA damage in tumor biopsy tissue

      To explore the mechanism of action of the bortezomib and clofarabine combination by examining
      markers of DNA damage and apoptosis in circulating tumor cells before and after treatment

      To characterize the changes in MDS residual disease burden that occur with bortezomib and
      clofarabine treatment

      To examine genomic alterations in circulating tumor DNA (ctDNA) that may be associated with
      response or resistance to clofarabine-bortezomib combination treatment.

      ELIGIBILITY:

        -  Study participants must have histologically confirmed solid tumors or lymphomas or
           myelodysplastic syndromes that have progressed on standard therapy known to prolong
           survival or for which no standard treatment options exist

        -  Age greater than or equal to 18

        -  No major surgery, radiation, or chemotherapy within 3 weeks prior to entering the study

        -  Adequate organ function

      STUDY DESIGN:

        -  This is an open-label Phase I trial

        -  The starting dose of clofarabine will be 1 mg/m2 administered intravenously on days 1
           through 5 of a 21-day cycle; bortezomib will be administered at 0.8 mg/m2 subcutaneously
           on days 1 and 4 of a 21-day cycle.

        -  Dose escalation will follow a 3+3 design, with dose limiting toxicities defined during
           cycle 1.

        -  Dose escalation will proceed in cohorts comprised of two separate groups of patients
           (one group of patients with solid tumor/lymphoma and one group of patients with MDS),
           with at least 1 from each group, until hematologic DLT or the second grade 2 hematologic
           toxicity is observed, at which point, dose escalation will proceed separately for two
           cohorts: (1) patients with solid tumors/lymphoma and (2) patients with MDS.

        -  Up to 33 patients will be accrued to a PD expansi n cohort at the MTD to further assess
           pharmacodynamic endpoints in tumor and blood.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and MTD
time frame: Cycle 1 (21 days)
description: To establish the safety, tolerability, and maximum tolerated dose (MTD) of bortezomib and clofarabine in patients with refractory solid tumors or lymphomas or myelodysplastic syndromes
measure: Biomarkers of DNA damage and apoptosis in circulating tumor cells
time frame: Baseline, cycle 1 day 1, and cycle 2 day 1
description: To determine the effects of the clofarabine-bortezomib combination on biomarkers of DNA damage and apoptosis in circulating tumor cells
measure: Biomarkers of cell death and DNA damage in tumor biopsy tissue
time frame: Baseline, cycle 1 day 1, and cycle 2 day 4/day 5
description: To determine the effects of the clofarabine-bortezomib combination on biomarkers of cell death and DNA damage in tumor biopsy tissue
arm group label: 1
arm group type: Experimental
description: Starting doses are clofarabine at 1 mg/m2 IV on days 1 through 5 of a 21-day cycle, and bortezomib at 0.8 mg/m2 subcutaneously on days 1 and 4 of a 21-day cycle.
intervention type: Drug
intervention name: Bortezomib plus Clofarabine
description: The proteasome inhibitor bortezomib and purine nucleoside metabolic inhibitor clofarabine demonstrated greater than additive activity in combination in preclinical xenograft models
arm group label: 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Naoko Takebe, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
last name: Murielle Hogu
phone: (240) 858-3335
email: murielle.hogu@nih.gov
last name: Naoko Takebe, M.D.
phone: (240) 541-4515
email: takeben@mail.nih.gov
facility: 
status: Recruiting
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2014-C-0161.html
description: NIH Clinical Center Detailed Web Page
citation: Duechler M, Linke A, Cebula B, Shehata M, Schwarzmeier JD, Robak T, Smolewski P. In vitro cytotoxic effect of proteasome inhibitor bortezomib in combination with purine nucleoside analogues on chronic lymphocytic leukaemia cells. Eur J Haematol. 2005 May;74(5):407-17. doi: 10.1111/j.1600-0609.2004.00406.x.
PMID: 15813915
citation: Kummar S, Chen HX, Wright J, Holbeck S, Millin MD, Tomaszewski J, Zweibel J, Collins J, Doroshow JH. Utilizing targeted cancer therapeutic agents in combination: novel approaches and urgent requirements. Nat Rev Drug Discov. 2010 Nov;9(11):843-56. doi: 10.1038/nrd3216. Epub 2010 Oct 29.
PMID: 21031001
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome
mesh term: Bortezomib
mesh term: Clofarabine