Combination Chemotherapy Followed by Donor Bone Marrow Transplant or Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Genetic Disorders
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|ClinicalTrials.gov Identifier: NCT00008307|
Recruitment Status : Unknown
Verified April 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
RATIONALE: Giving chemotherapy drugs, such as fludarabine and melphalan, before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by donor bone marrow transplant or peripheral stem cell transplant works in treating patients with hematologic cancer or genetic disorders.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes||Biological: anti-thymocyte globulin Drug: cyclosporine Drug: fludarabine phosphate Drug: melphalan Drug: methylprednisolone Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: syngeneic bone marrow transplantation||Phase 2|
- Determine the hematopoietic recovery in patients with hematologic malignancies or genetic disorders treated with fludarabine and melphalan followed by allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation.
- Determine the chemotherapeutic toxicity of this regimen in these patients.
- Determine the relapse and survival of patients treated with this regimen.
- Determine the incidence of graft-versus-host disease in patients treated with this regimen.
OUTLINE: Patients receive fludarabine IV on days -6 to -2 and melphalan IV on days -3 and -2. Patients with a non-HLA-identical family member may also receive anti-thymocyte globulin on days -4 to -1. Patients undergo allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients receive graft-vs-host disease prophylaxis comprising mycophenolate mofetil twice daily beginning on day -3, methylprednisolone beginning on day 5 and continuing over 8 weeks, and cyclosporine IV or orally beginning on day -3 and continuing until at least 6 months post-transplantation.
Patients are followed at 1, 3, and 6 months, and then at 1 year post-transplantation.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 5-6 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Official Title:||Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation|
|Study Start Date :||April 1998|
- Hematopoietic recovery
- Incidence of graft-versus-host disease
- Chemotherapeutic toxicity
- Relapse and survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008307
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|Study Chair:||David G. Savage, MD||Herbert Irving Comprehensive Cancer Center|