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Phase I Study of Anti-CD45 Monoclonal Antibody, Cytarabine, Cyclophosphamide, and Total-Body Irradiation With or Without Alemtuzumab in Patients Undergoing Allogeneic Stem Cell Transplantation For Advanced Leukemia or Other Hematologic Malignancy
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Anti-CD45 Monoclonal Antibody, Cytarabine, Cyclophosphamide, and Total-Body Irradiation With or Without Alemtuzumab in Treating Patients Undergoing a Donor Stem Cell Transplant For Advanced Leukemia or Other Hematologic Cancer
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase I
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Treatment
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Active
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45 and under
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Other
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BCM-H-12870 H 12870, BCM-ADVL, NCT00601380
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Objectives Primary -
To evaluate the toxicity and the anti-tumor activity of anti-CD45 monoclonal antibody in patients with relapsed or resistant leukemia or other hematologic malignancy undergoing allogeneic stem cell transplantation.
Secondary - To describe the effects of anti-CD45 on normal hematopoiesis and on complement levels.
- To describe the effects of anti-CD45 on leukemic blast cells.
Entry Criteria Disease Characteristics:
- Confirmed diagnosis of advanced leukemia or other hematologic malignancy, including acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia (CML), or myelodysplastic disease
- Advanced features include any of the following:
- Induction failure, prolonged induction beyond 6 weeks
- Incomplete response to salvage therapy
- CML in blast crisis or acute leukemia in chemotherapy resistant relapse
- Secondary leukemia or secondary myelodysplastic disease
- CD45 present on leukemic blasts at a level of > 95% as documented by flow cytometry
- HLA identical sibling donor or 5/6 matched related donor OR fully matched or 5/6 matched unrelated donor available
- No T-cell lymphoblastic lymphoma
Prior/Concurrent Therapy:
Patient Characteristics:
- Lansky performance status (PS) 70-100%% or Karnofsky PS 70-100%
- Life expectancy > 6 weeks (not limited by diseases other than leukemia)
- No symptomatic cardiac disease, or evidence of significant cardiac disease by echocardiogram (i.e., shortening fraction < 25%)
- No liver disease that on evaluation by the Principal Investigator precludes ablative radio/chemotherapy or successful transplantation
- Creatinine ≤ 2 times upper limit of normal
- No known allergy to rat serum products
- No severe infection that on evaluation by the Principal Investigator precludes ablative radio/chemotherapy or successful transplantation
- No severe personality disorder or mental illness
- No documented HIV positivity
- Not pregnant or lactating
Expected Enrollment 24Outcomes Primary Outcome(s)Toxicity by NCI CTCAE criteria
Secondary Outcome(s)Effects of anti-CD45 on normal hematopoiesis and on complement levels Effects of anti-CD45 on leukemic blast cells
Outline - Preparative regimen: Patients receive treatment based on their relationship to the stem cell donor (related or unrelated).
- HLA-identical or 5/6 matched related donors: Patients receive anti-CD45 monoclonal antibody IV on days -5 to -2, cytarabine IV twice daily on days -7 to -5, cyclophosphamide IV on days -7 and -6. Patients also undergo total body irradiation twice daily on days -4 to -1.
- HLA-identical or 5/6 matched unrelated donors: Patients receive anti-CD45 monoclonal antibody, cytarabine, and cyclophosphamide and undergo total-body irradiation therapy as above. Patients also receive alemtuzumab IV on days -8 to -6.
- Allogeneic stem cell transplantation: All patients undergo peripheral blood or bone marrow stem cell infusion on day 0.
- Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV beginning on day -2 and continuing as per the treating physician.
Trial Contact Information
Trial Lead Organizations Dan L. Duncan Cancer Center at Baylor College of Medicine ![](https://webarchive.library.unt.edu/eot2008/20081014072037im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081014072037im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081014072037im_/http://www.cancer.gov/images/spacer.gif) | Robert Krance, MD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20081014072037im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20081014072037im_/http://www.cancer.gov/images/spacer.gif) | Trial Sites
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U.S.A. |
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Texas |
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Houston |
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| | | | | | | | Methodist Hospital |
| | Marlen Dinu | |
| | Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital |
| | Marlen Dinu | |
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Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20081014072037im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | PHASE I/II STUDY OF ANTI-HUMAN CD45 MONOCLONAL ANTIBODIES IN PATIENTS WITH ADVANCED LEUKEMIA PRIOR TO ALLOGENEIC STEM CELL TRANSPLANTATION | ![](https://webarchive.library.unt.edu/eot2008/20081014072037im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2003-02-05 | ![](https://webarchive.library.unt.edu/eot2008/20081014072037im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2011-04-05 (estimated) | ![](https://webarchive.library.unt.edu/eot2008/20081014072037im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00601380 | ![](https://webarchive.library.unt.edu/eot2008/20081014072037im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2007-12-13 | ![](https://webarchive.library.unt.edu/eot2008/20081014072037im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2008-04-13 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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