Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors
OBJECTIVES:
Primary
- Compare the progression-free survival (PFS) of patients with Hodgkin lymphoma (HL) or
non-Hodgkin lymphoma (NHL) treated with different disease-specific high-dose
conditioning regimens followed by autologous stem cell transplantation.
- Compare the PFS of patients with high-risk vs standard-risk HL, NHL, or multiple
myeloma, in terms of disease progression or relapse after transplant.
- Determine if known prognostic factors (when available) can be used to group patients
with acute lymphocytic leukemia or acute myeloid leukemia into high risk and standard
risk groups.
Secondary
- Compare the toxicity of the different disease-specific high-dose conditioning regimens
in these patients.
- Compare the overall survival of patients treated with these regimens.
OUTLINE: Patients are retrospectively stratified according to risk for recurrence (low
[standard]-risk vs high-risk). Patients are assigned to a conditioning regimen based on
disease, age, and co-morbidities.
- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL): Patients receive 1
of the following conditioning regimens followed by autologous stem cell transplant
(ASCT):
- CT6: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and
undergo total-body irradiation twice daily on days -3 to -1. Patients undergo ASCT
on day 0.
- BuC2iv: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4
for a total of 16 doses and cyclophosphamide IV over 2 hours on days -3 and -2.
Patients undergo ASCT on day 0.
- Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL): Patients receive 1 of the
following conditioning regimens followed by ASCT:
- CBV: Patients receive etoposide IV continuously over 34 hours beginning on day -8,
cyclophosphamide IV over 2 hours on days -7 to -4, and carmustine IV over 2 hours
on day -3. Patients undergo ASCT on day 0.
- BuC2iv: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4
for a total of 16 doses and cyclophosphamide IV over 2 hours on days -3 and -2.
Patients undergo ASCT on day 0.
- Multiple myeloma (MM) or amyloidosis: Patients receive 1 of the following conditioning
regimens followed by ASCT:
- M200: Patients receive 200 mg/m² of melphalan IV over 30 minutes on day -2.
Patients undergo ASCT on day 0.
- M120: Patients receive 120 mg/m² of melphalan IV over 30 minutes on day -2.
Patients undergo ASCT on day 0.
- Testicular cancer: Patients receive the following conditioning regimen followed by
tandem ASCT:
- VCp: Patients receive etoposide IV over 2-3 hours and carboplatin IV over 30
minutes on days -6 to -4. Patients undergo ASCT on day 0. Approximately 4-8 weeks
after the first transplant, patients receive etoposide IV over 2-3 hours and
carboplatin IV over 30 minutes on days -6 to -4. Patients undergo a second ASCT on
day 0.
- Neuroblastoma or small round blue cell tumor: Patients receive the following
conditioning regimen followed by tandem ASCT:
- TtC1500/ECpM: Patients receive thiotepa IV over 2 hours on days -7 to -5 and
cyclophosphamide IV over 1-2 hours on days -5 to -2. Patients undergo ASCT on day
0. Approximately 4-8 weeks after the first transplant, patients receive etoposide
IV continuously and carboplatin IV continuously on days -7 to -4 and melphalan IV
over 30 minutes on days -7 to -5. Patients undergo a second ASCT on day 0.
- Other solid tumors: Patients receive the following conditioning regimen followed by
ASCT:
- CTtCp: Patients receive cyclophosphamide IV continuously, carboplatin IV
continuously, and thiotepa IV continuously on days -7 to -4. Patients undergo ASCT
on day 0.
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
5 years
No
Philip L. McCarthy, MD
Principal Investigator
Roswell Park Cancer Institute
United States: Institutional Review Board
CDR0000565267
NCT00536601
June 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |