Status:
TERMINATED
Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Kidney Cancer
Leukemia
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
Brief Summary
RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy, or that have become cancer. Sometimes the transplante...
Detailed Description
OBJECTIVES: * Determine if a nonmyeloablative regimen comprising cyclophosphamide, fludarabine, and radiotherapy followed by cyclosporine and mycophenolate mofetil provides a prompt and durable donor...
Eligibility Criteria
Inclusion
- Standard patients will be enrolled into Arms 1-6. High risk patients (transplant with aplasia) will be considered separately in Arm 7.
- Age and Graft criteria (all patients)
- Patient's \< or = 75 years old with a 5/6 or 6/6 related donor match are eligible.
- Patient's \< or = 75 years who have a 7-8/8 HLA-A,B,C,DRB1 allele matched unrelated volunteer marrow and/or peripheral blood stem cell (PBSC) donor match are eligible.
- Disease Criteria (standard risk patients)
- Acute myelogenous leukemia
- Acute lymphocytic leukemia
- Chronic myelogenous leukemia all types except blast crisis (note treated blast crisis in chronic phase is eligible).
- Non-Hodgkins lymphoma (NHL), Hodgkins, chronic lymphocytic leukemia, multiple myeloma demonstrating chemosensitive disease
- Acquired bone marrow failure syndromes
- Myelodysplastic syndrome of all subtypes including refractory anemia (RA) or all IPSS categories if severe pancytopenia, transfusion requirements not responsive to therapy, or high risk cytogenetics. Blasts must be less than 5%. If \>5% requires therapy (induction or Hypomethylating agents) pre-transplant to decrease disease burden.
- Renal cell cancer,
- Chronic myeloproliferative disorder, i.e. myelofibrosis
- Disease Criteria (High risk patients on Arm 7)
- Patients with refractory leukemia or MDS may be taken to transplant in aplasia after induction or re-induction chemotherapy or radiolabeled antibody. These high risk patients will be analyzed separately in Arm 7.
- Adequate organ function and performance status (all patients)
Exclusion
- Pregnancy or breast feeding
- Evidence of HIV infection or known HIV positive serology
- Active serious infection
- Congenital bone marrow failure syndrome
- Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI)
- Chronic myelogenous leukemia (CML) in refractory blast crisis
- Intermediate or high grade NHL, mantle cell NHL, and Hodgkins disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.
- Multiple Myeloma progressive on salvage chemotherapy.
- DONOR ELIGIBILITY
- Related will undergo apheresis - if donor is unable to undergo apheresis, a bone marrow harvest is acceptable; unrelated volunteer donors must be able to undergo bone marrow harvest or apheresis.
- All donors must be able to give informed consent.
- Donors weighing less than 40 kg (children) will need evaluation by a pediatrician for suitability of the apheresis procedure. Informed consent must be obtained from parent or guardian as applicable for minors.
Key Trial Info
Start Date :
March 26 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2019
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT00303719
Start Date
March 26 2002
End Date
May 8 2019
Last Update
May 12 2020
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455