Stem Cell Transplant With Specially Treated Cells in Treating Patients With Acute Leukemia
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
An autologous peripheral stem cell or bone marrow transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Using stem cells or bone marrow cells that are treated in the laboratory may be an effective treatment for acute leukemia.
This clinical trial is studying how well an autologous stem cell transplant using specially treated cells works in treating patients with acute leukemia.
| Condition | Intervention |
|---|---|
|
AML ALL (High Risk) |
Procedure: Ex vivo expansion of mafosfamide purged marrow or mobilized stem cells with growth factors (rhSCF and rhTPO) |
| 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: | Pilot Study of Ex Vivo Expansion of Mafosfamide-Purged CD34-Positive Cells for Autologous Peripheral Blood Stem Cell or Bone Marrow Transplantation in Patients With Acute Leukemia |
- To assess the feasibility of ex vivo expanding a CD34 selected, mafosfamide purged autograft.
- To assess the duration of aplasia associated with mafosfamide purging and ex vivo cytokine expanded autografting for high risk acute leukemia.
- To estimate the event-free survival following mafosfamide purging and ex vivo cytokine expanded autografting for high risk acute leukemia
- To obtain blood samples for future laboratory studies that may include immune reconstitution.
| Estimated Enrollment: | 25 |
| Study Start Date: | September 2005 |
Patients will receive infusions of cyclophosphamide and an infusion or injection of G-CSF once a day for 7-14 days followed by collection of their peripheral stem cells. Some patients may also undergo bone marrow collection. Patients' stem cells and/or bone marrow will be treated in the laboratory. Patients will then receive busulfan for 4 days followed by cyclophosphamide for 4 days. Two days later, patients will undergo autologous peripheral stem cell or bone marrow transplant and then receive an infusion or injection of G-CSF once a day until blood counts return to normal.
The goal of this pilot clinical study is to shorten the duration of aplasia associated with mafosfamide purged autologous transplants for acute leukemia using the cytokine cocktail of recombinant human stem cell factor (rhSCF), recombinant human granulocyte colony stimulating factor (rhG-CSF) and recombinant human thrombopoeitin (rhTPO) for ex vivo expansion.
After finishing treatment, patients will be evaluated periodically for at least 5 years.
Eligibility| Ages Eligible for Study: | 1 Year to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- AML in high risk CR1 without a matched family donor
- AML in CR2 without an HLA-identical sibling donor
- High Risk ALL with an HLA-identical sibling donor
Exclusion Criteria:
- Available suitable matched HLA-identical sibling donor
- Intermediate or good-risk leukemia
Contacts and Locations| United States, Maryland | |
| SKCCC at Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21234 | |
| Principal Investigator: | B. Douglas Smith, M.D. | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00246649 History of Changes |
| Other Study ID Numbers: | J0563 |
| Study First Received: | October 27, 2005 |
| Last Updated: | December 16, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
Mafosfamide Growth Factor Stem Cell Bone Marrow |
Additional relevant MeSH terms:
|
Leukemia Neoplasms by Histologic Type Neoplasms Mitogens Mafosfamide Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013