Chronic Lymphocytic Leukemia, Lymphoma, Multiple Myeloma
Conditions
Brief summary
Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma
Detailed description
Treatment plan * Conditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2. * Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL. * Melphalan will be administered following the completion of Fludarabine infusion at day -2. * In case of unrelated donor HCT, thymoglobuline 3 mg/kg in N/S 500 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500 mL (less than 2 mg/mL) IV qd on days -4, -3 and -2. Infuse over 4 hrs. Premedicate with Avil 45.5 mg IVP and Tylenol 600 mg po. Methylprednisolone 2 mg/kg in D5W 100 ml will be given IV over 30 minutes before thymoglobulin (or lymphoglobuline) on days -4 to -2. * Before the administration of melphalan, prehydration will be done intravenously with 0.9% NS 1L over 3 hours. * 30 minutes before melphalan infusion, premedication with dexamethasone 10 mg and ativan 1 mg i.v. push will be given. Appropriate antiemetics such as ondansetron 8 mg i.v. push every 4-6 hours and ativan 1-2 mg i.v. push every 4-6 hours will be administered. * Hydration with 0.9% NS at 80 mL/hour will be administered for at least 7 days. Appropriate amount of KCl should be mixed. * GVHD prophylaxis will include cyclosporine A (CSA) and methotrexate.
Interventions
* Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL. * Melphalan will be administered following the completion of Fludarabine infusion at day -2.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients must be 15 years of age or older and 65 years of age or younger * Patients with CLL, lymphoma, or multiple myeloma will be included in this study * No prior anti-cancer treatment should be done within 30 days. * Informed consent should be given. * Patients should have an HLA-identical or single HLA-locus mismatched donor. * Karnofsky performance scale should be 50 or over (see Appendix I).
Exclusion criteria
* Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the stem cell transplant treatment unlike, and making informed consent impossible. * Patients with high serum creatinine level will be excluded. * Patients should have uncontrolled infection. * No major anticipated illness or organ failure incompatible with survival from stem cell transplant. * Serum bilirubin less than or equal to 4.0 mg/dL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) | 9years | -To evaluate engraftment, chimerism, toxicity, incidence of acute graft-versus-host disease (GVHD), and day 100 treatment-related mortality (TRM) following allogeneic nonmyeloablative stem cell transplantation using fludarabine and melphalan conditioning regimen in patients with chronic lymphocytic leukemia (CLL), lymphoma, and multiple myeloma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| include tumor response, incidence of chronic GVHD, and immune reconstitution. | 9years | -The secondary objectives include tumor response, incidence of chronic GVHD, and immune reconstitution. |
Countries
South Korea