Status:
COMPLETED
Early Administration of ATG Followed by Cyclophosphamide, Busulfan and Fludarabine Before a Donor Stem Cell Transplant in Patients With Hematological Cancer
Lead Sponsor:
Northside Hospital, Inc.
Collaborating Sponsors:
Blood and Marrow Transplant Group of Georgia
Conditions:
Myeloproliferative Disorders
Kidney Cancer
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cell...
Detailed Description
OBJECTIVES: * To assess the percentage of patients with hematological malignancies or renal cell carcinoma who achieve \> 90% donor T-cell chimerism at 30 days after treatment with reduced-intensity ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of one of the following:
- Chronic myeloid leukemia (CML)
- Philadelphia chromosome (Ph)- and/or BCR-ABL-positive disease
- In chronic or accelerated phase
- Suboptimal response to imatinib mesylate (i.e., no hematologic complete response by 3 months, no major cytogenetic response by 6 months, or no complete cytogenetic response by 1 year)
- CML in blastic transformation allowed provided patient achieved complete remission (CR) or second chronic phase after treatment with imatinib mesylate or chemotherapy
- Chronic lymphocytic leukemia meeting one of the following criteria:
- Rai stage III or IV disease
- Rai stage I or II disease that failed standard therapy (i.e., disease is progressing after ≥ 1 course of standard therapy)
- Non-Hodgkin lymphoma (NHL) meeting one of the following criteria:
- Indolent NHL
- Clinical stage III or IV disease or bulky stage II disease (i.e., ≥ one lymphoid mass \> 5 cm in ≥ one dimension)
- Relapsed after primary therapy OR is refractory to therapy
- Aggressive NHL
- Is not considered curable with standard chemotherapy or autologous stem cell transplantation (i.e., relapsed after autologous stem cell transplantation)
- Chemotherapy-responsive disease
- Multiple myeloma
- Durie-Salmon stage II or III disease
- Durie Salmon stage I disease allowed provided β2 microglobulin level \> 3 mg/dL
- Acute myeloid leukemia or acute lymphocytic leukemia
- In CR (defined as \< 5% blasts in bone marrow and no circulating blasts) AND has any of the following poor prognostic features:
- WBC \> 100,000/mm\^3 at presentation
- In second or greater remission
- Adverse-risk cytogenetics (i.e., Ph1-positive, 11q23 translocation, -5, -7, complex translocations, or other recognized adverse-risk cytogenetics)
- Renal cell carcinoma
- Stage IV disease
- Clear cell morphology
- Myelodysplastic syndromes
- Bone marrow blasts ≤ 10% on last bone marrow biopsy prior to transplantation
- Myeloproliferative disease
- Anticipated life expectancy on conventional therapy \< 10 years
- No uncomplicated essential thrombocythemia or primary polycythemia
- Hodgkin lymphoma
- Relapsed after ≥ 1 standard-dose chemotherapy regimen
- Not considered curable by autologous stem cell transplantation
- No clinical evidence of active CNS involvement
- Previously treated leptomeningeal disease allowed provided CSF cytology is negative at the time of assessment for transplantation
- Available 6/6 allele match (i.e., HLA-A, B, DRβ1)matched related donor
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Bilirubin \< 3 times normal (unless abnormality due to malignancy)
- AST and ALT \< 3 times normal (unless abnormality due to malignancy)
- Creatinine ≤ 2.0 mg/dL
- LVEF ≥ 40% by MUGA or ECHO
- DLCO ≥ 40% of predicted
- FEV-1 ≥ 50% of predicted
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Deemed to be an appropriate candidate for allogeneic SCT
- No evidence of myocardial infarction within the past 6 months
- No psychological or social condition that may interfere with study participation
- No serious uncontrolled localized or active systemic infection
- No second malignancy within the past 3 years except for completely excised nonmelanotic skin cancer or in situ carcinoma of the cervix
- No chronic inflammatory disorder requiring the continued use of glucocorticoids or other immunosuppressive medications
- No known HIV positivity
- No hypersensitivity to E. coli-derived proteins
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00787761
Start Date
April 1 2007
End Date
May 1 2012
Last Update
October 1 2012
Active Locations (1)
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1
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342