Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation (ADVL)
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Purpose
Participants in this study have a hematologic malignancy which is a disorder in the bone marrow that affects the body's ability to create blood. Participants might benefit from receiving an allogeneic stem cell transplant (meaning the cells come from a donor). The participants donor is a family member. Stem cells are cells in the bone marrow and blood that can form a whole new blood system.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: CAMPATH-1H Drug: Anti-CD45 Drug: Ara-C Drug: Cyclophosphamide Drug: Mesna Radiation: Total Body Irradiation |
Phase 1 |
Baylor College of Medicine has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation (ADVL) |
- To evaluate the toxicity and the anti-tumor activity of anti-human CD45 antibodies (anti-CD45) administered to patients with relapsed/resistant leukemia prior to bone marrow transplantation. [ Time Frame: 28 days and 100 days post transplant ] [ Designated as safety issue: Yes ]
- To describe the effects of anti-CD45 on normal hematopoiesis and on complement levels and to describe the effects of anti-CD45 on leukemic blast cells. [ Time Frame: 100 days post transplant ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 24 |
| Study Start Date: | February 2003 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: CAMPATH-1H
Day-8 through Day-6 according to institutional SOPs
Drug: Anti-CD45
Day-5 400 μg/kg
Drug: Ara-C
day-7 through day-5 3000 mg/m2 q 12h
Drug: Cyclophosphamide
Day-7 through Day-6 45 mg/kg
Drug: Mesna
Days -7 and -6 45 mg/kg divided into 5 doses
Radiation: Total Body Irradiation
150 cGy x 2 (5/6 matched related) 180 cGy x 2 (5/6 matched unrelated)
|
Detailed Description:
Patients are given high doses of chemotherapy before receiving a stem cell transplant to keep their immune system from rejecting the donor stem cells and to kill any diseased cells that remain in the body. To try and improve on the results of transplants that use high dose chemotherapy alone, we are adding an agent called anti-CD45 to the treatment prior to the stem cell transplant. Anti-CD45 is an antibody that specifically finds and destroys leukemia cells.
Patients will receive the anti-CD45 with high dose chemotherapy (including Ara-C and Cyclophosphamide) and radiotherapy. Patients will also receive Mesna which is a drug that helps prevent bladder damage which can be caused by the cyclophosphamide. High dose radiotherapy is also known as Total Body Irradiation or TBI.
Patients will receive the anti-CD45, high dose chemotherapy, and high dose radiotherapy before the stem cell transplant. We expect participation in this study will last 2 years.
A summary of the treatment follows:
- Day - 7: Ara-C, Cyclophosphamide, Mesna
- Day - 6: Ara-C, Cyclophosphamide, Mesna
- Day - 5: Ara-C, Anti-CD45
- Day - 4: Anti-CD45, TBI
- Day - 3: Anti-CD45, TBI
- Day - 2: Anti-CD45, TBI
- Day - 1: TBI
- Day 0: Stem Cell Infusion (transplant)
Eligibility| Ages Eligible for Study: | up to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with advanced leukemia or other hematologic malignancy including AML, ALL, CML, and MDS. Advanced features include: a) Induction failure, prolonged induction beyond 6 weeks b) Incomplete response to salvage therapy c) CML in blast crisis or acute leukemia in chemotherapy resistant relapse d) secondary leukemia or secondary myelodysplastic disease
- Patients must have a suitable HLA identical sibling donor or 5/6 matched related donor, or fully matched or 5/6 matched unrelated donor, or haploidentical related donor.
Exclusion Criteria:
1. Patients with a life expectancy (2X normal for age) 7. Patients with known allergy to rat serum products 8. Patients with a Lansky score <60% or Karnofsky score <60%. 9. Patients with severe infection that on evaluation by the PI precludes ablative radio/chemotherapy or successful transplantation. 10. Patients with sever personality disorder or mental illness. 11. Patients with documented HIV positivity 12. Pregnant or lactating females
Contacts and Locations| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| Texas Children's Hospital | |
| Houston, Texas, United States, 77030 | |
| Study Chair: | Malcolm K Brenner, MD | Baylor College of Medicine |
More Information
No publications provided
| Responsible Party: | Robert Krance, MD, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00057005 History of Changes |
| Obsolete Identifiers: | NCT00601380 |
| Other Study ID Numbers: | H12870, ADVL |
| Study First Received: | March 26, 2003 |
| Last Updated: | January 19, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Baylor College of Medicine:
|
LEUKEMIA |
Additional relevant MeSH terms:
|
Leukemia Neoplasms by Histologic Type Neoplasms Antibodies, Monoclonal Cyclophosphamide Campath 1G Alemtuzumab Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Immunosuppressive Agents Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 19, 2013