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| Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Information provided by (Responsible Party): | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00496340 |
Purpose
The objective of this trial is to determine whether a regimen of pentostatin and busulfan (IV) can facilitate engraftment of HLA partially compatible siblings and unrelated donor transplants by using CD4+ laboratory-guided immunosuppression among 41 transplant patients meeting the inclusion criteria.
| Condition | Intervention | Phase |
|---|---|---|
|
Hematologic Malignancies |
Drug: Pentostatin/busulfan/rituximab/allogeneic hematopoietic cell transplant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Pentostatin and Targeted Busulfan as a Novel Reduced Intensity Regimen for Allogeneic Hematopoietic Stem Cell Transplantation Using Laboratory-Guided (CD4-guided) Immunosuppression. |
| Estimated Enrollment: | 41 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Pentostatin/busulfan/rituximab/allogeneic hematopoietic cell transplant
|
Drug: Pentostatin/busulfan/rituximab/allogeneic hematopoietic cell transplant
Pre-conditioning therapy: All patients will receive pentostatin 4 mg/m2 on day -28. Patients may receive additional doses on days -21 & -14 depending on cell counts. Conditioning:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Recipients:
Organ function:
Donors:
Exclusion Criteria:
Recipients:
Presence of any of the following comorbid conditions
Donors:
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Principal Investigator: | Marcie Tomblyn, MD | H. Lee Moffitt Cnacer Center & Research Center |
More Information
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00496340 History of Changes |
| Other Study ID Numbers: | MCC15009 |
| Study First Received: | June 29, 2007 |
| Last Updated: | April 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Pentostatin Busulfan Rituxan Allogeneic Hematopoietic Stem Cell Transplantation |
|
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases Busulfan Rituximab Pentostatin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Adenosine Deaminase Inhibitors Enzyme Inhibitors Antirheumatic Agents |