Multiple Myeloma Clinical Trial
Official title:
Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
NCT number | NCT01499147 |
Other study ID # | 2000-0117 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2000 |
Est. completion date | May 2013 |
Verified date | October 2018 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
New conditioning regimens are still needed to maximize efficacy and limit treatment-related deaths of allogeneic transplantation for advanced hematologic malignancies. Over the past several years, the investigators have evaluated several new conditioning regimens that incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic activity with alkylating agents. Recent data have suggested that fludarabine may be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity previously observed with cyclophosphamide/ busulfan regimens.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with the following diseases: - Acute myeloid or lymphocytic leukemia in first remission at standard or high-risk for recurrence. - Acute leukemia in greater than or equal to second remission, or with early relapse, or partial remission. - Chronic myelogenous leukemia in accelerated phase or blast-crisis. - Chronic myelogenous leukemia in chronic phase - Recurrent or refractory malignant lymphoma or Hodgkin's disease - Multiple myeloma. - Chronic lymphocytic leukemia, relapsed or with poor prognostic features. - Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features. - Severe aplastic anemia after failure of immunosuppressive therapy. - Age 10-65 years. - Zubrod performance status less than or equal to 2. - Adequate cardiac and pulmonary function. Patients with decreased LVEF < 40% or DLCO < 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol. - Patient or guardian able to sign informed consent. Exclusion Criteria: - Life expectancy is severely limited by concomitant illness. - Serum creatinine greater than 1.5 mg/dL or Creatinine Clearance less than 50 ml/min . - Serum bilirubin greater than or equal to 2.0 mg/dl, SGPT greater than 3 x upper limit of normal - Evidence of chronic active hepatitis or cirrhosis - HIV-positive - Patient is pregnant |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Chicago Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Engraftment. | Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant. | Up to 30 days post-transplant | |
Secondary | Participants With 100 Day Transplant-related Mortality. | Day 100 transplant-related mortality was measured in both groups. | Up to 100 days post-transplant. | |
Secondary | Time to ANC and Platelet Engraftment | Days to ANC or platelet engraftment | Up to 30 days post-transplant | |
Secondary | Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD). | Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant. | Up to 100 days post-transplant (acute GVHD). |
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