| Last Verified: | May/31/2013 |
| First Submitted: | February/4/2003 |
| Estimated Enrollment Submitted: | February/4/2003 |
| First Posted: | February/5/2003 |
| Last Update Submitted: | June/18/2013 |
| Last Update Posted: | July/23/2013 |
| : | April/29/2013 |
| : | June/18/2013 |
| : | July/23/2013 |
| Actual Study Start Date: | October/31/2000 |
| Estimated Primary Completion Date: | August/31/2011 |
| Estimated Study Completion Date: | August/31/2011 |
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
| Study Type: | Interventional |
| Allocation: | Non-Randomized |
| Primary Purpose: | Treatment |
| Masking: | None (Open Label) |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Regimen A Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY. | Drug: Regimen A Given IV |
| Experimental: Regimen B-1 Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY.. | |
| Experimental: Regimen B-2 Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY. | |
| Experimental: Regimen C Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2. | Drug: Regimen C Given orally 1mg/kg/dose (or 40mg/m2/dose for young children) |
| Experimental: Regimen B-3 Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3. | |
| Experimental: Regimen D Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3. | Drug: Regimen D infusion |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Criteria: | Eligibility Criteria: 1. Patients with histologic confirmation of the following diseases are eligible: 1. AML in first, second or greater remission 2. AML in early relapse, defined at <30% marrow blasts 3. ALL in second or greater complete remission 4. High risk ALL in first complete remission, with high risk being defined by the presence of t(4;11), t(9;22), or t(8;14) translocation, or patients presenting with extreme hyperleukocytosis (initial WBC >500 K/ml) or failure to achieve a complete remission after standard induction therapy. 5. CML 6. Myelodysplastic syndromes (including evolution to AML, e.g., Refractory Anemia with Excess Blasts (RAEB), or Refractory Anemia with Excess Blasts in transformation (RAEB-t). 7. Lymphoma (intermediate and high grade) chemosensitive (CR or PR) after first or greater relapse or chemosensitive to first line therapy but only achieving PR. 8. Hematologic Disease and Inherited Immunodeficiencies 9. Hodgkin's disease, relapsed or refractory to standard treatments. 2. Patients must be less than or equal to 55 years of age. 3. Patients (or guardians if minor) must be able to give informed consent. Children older than 11 years of age must assent to the process. 4. Patients or their guardians must demonstrate proof-of-payment. 5. Patients must have an ECOG Performance Status of 2 or less. (See Appendix I) 6. Patients must have no evidence of active infection at the time of transplantation. 7. Patients must be HIV nonreactive. 8. Patients must have a pre-transplant, multi-organ assessment prior to transplantation with the following outcome: 1. resting ejection fraction of 50% or greater (or shortening fraction greater than 28% for small children). 2. Diffusion capacity of 50% or greater of predicted, a FEV1 of 50% or greater, and a P2O of 80 mm Hg as demonstrated on pulmonary function testing. 3. serum creatinine of less than or equal to 2.0 mg/dL and/or a corrected creatinine clearance of 50 ml/min or greater on 24 hr urine. 4. A total bilirubin of less than 2.5 mg/dL and an AST less than 4 times the upper limits of normal. 9. Females who are childbearing age may not be pregnant or lactating and must have a current negative pregnancy test Ineligibility Criteria: - Patients who have a life expectancy of less than three months with therapy. - Patients who have an ECOG performance status greater than 2, (See Appendix I) or Lansky Scale < 70%. - Patients who have angina and/or congestive heart failure requiring treatment, or who have had a myocardial infarction within the past year. - Patients who have a resting ejection of less than 50% (or shortening fraction less than 28%) and who have not been cleared for transplant by cardiology - Patients who have severe renal disease as demonstrated by a serum creatinine greater than 2.0 mg/dL and/or a corrected creatinine clearance less than 50 ml/min. (corrected for BSA of 1.73 m¬2) - Patients who have had any complication that makes the risk of death during transplantation from non-malignant causes greater than the risk of relapse. - Patients who have any active infection such as a soft tissue infection, sinus infection, dental infection, fungal infection or hepatitis including chronic active hepatitis; if the infection is successfully treated, the patient may be reconsidered for transplantation at a later date. - Patients who have decreased pulmonary function due to any disorder as demonstrated by a diffusion capacity of less than 50% of predicted, a FEV1 of less than 50% of predicted or a PO2 of less than 80 mm Hg pulmonary function testing. - Patients who have decreased liver function as demonstrated by a total bilirubin of greater than 2.5 mg/dL and/or an AST greater than 4 times the upper limits of normal. - Patients who have diabetes mellitus will be considered on a case-by-case basis. However, patients with diabetes who are not controlled by medical management will be ineligible. -Patients who have a significant psychiatric illness will be considered on a case- by-case basis. With the patient's consent, their Mental Health Care worker will assist the managing transplant physicians in determining if the patient can safely undergo transplantation and comply with followup recommendations. - Psychosocial assessment by the bone marrow transplant team may identify individuals for whom this form of therapy may be contraindicated. This decision will be based upon estimated adequacy of patient support systems and prediction of patient's compliance with medications, required diagnostic procedures and/or follow-up care. - Females who are childbearing age may not be pregnant or lactating and must have a current negative pregnancy test - Patients who had a stem cell transplant less than one year earlier |