Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Multiple Myeloma Leukemia Myelodysplastic Syndrome |
Drug: Busulfan, Fludarabine, Cytoxan |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide |
- To determine the optimal regimen of post-graft immunosuppression with high-dose Cy following fludarabine, busulfan, and transplantation of fully HLA-matched bone marrow that leads to an acceptable incidence of grades III/IV acute GVHD. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 95 |
| Study Start Date: | May 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
-
Drug: Busulfan, Fludarabine, Cytoxan
- BMT
- Cyclophosphamide
- Allogeneic
- Transplantation
Busulfan once a day for 4 days
Fludarabine once a day for 4 days
Bone marrow transplant
Cytoxan two doses
A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)
However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT
Eligibility| Ages Eligible for Study: | up to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients ages between 0 to and 65 years of age.
- Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
- Acute lymphocytic leukemia (ALL) in CR1 with high risk features
Acute myeloid leukemia (AML) in CR1 with high risk features defined as:
i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]
- Acute Leukemias in 2nd or greater remission
- Refractory or Relapsed AML
- AML transformed from MDS
- Myelodysplastic syndrome (MDS) beyond refractory anemia
- Chronic myeloid leukemia (CML)
- Chronic myelomonocytic leukemia
- Philadelphia-negative myeloproliferative disorder
- Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma
- Multiple Myeloma-Stage III
Exclusion Criteria:
- Prior autologous or allogeneic stem cell transplant.
- Performance status greater than 2
- Active infection.
- Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
- Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted
- Inadequate Serum creatinine clearance <60
- InadequatebHepatic function
- Positive serology for HIV-1, 2 or HTLV-1, 2.
- Pregnancy. Female patient must have negative pregnancy test
Contacts and Locations| United States, Maryland | |
| The Sydney Kimmel Comprehensive Cancer center | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Texas | |
| Marcos deLima, MD | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Paul V. O'Donnell, M.D., Ph.D. | |
| Seattle, Washington, United States, 98109 | |
| Study Chair: | Leo Luznik, MD | Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00809276 History of Changes |
| Other Study ID Numbers: | J0844, NA_00017193 |
| Study First Received: | December 16, 2008 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
Acute lymphocytic leukemia (ALL) Acute myeloid leukemia (AML) Acute Leukemia Refractory or Relapsed AML Myelodysplastic syndrome (MDS) Chronic myeloid leukemia (CML) Chronic myelomonocytic leukemia Hodgkin's Lymphoma Non-Hodgkin's lymphoma Philadelphia-negative myeloproliferative disorder |
Hematologic Malignancies Transplantation Busulfan Fludarabine Cytoxan Bone Marrow Allogeneic Related donor unrelated donor |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Hematologic Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Neoplasms by Site Busulfan Cyclophosphamide Fludarabine monophosphate Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013