NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders
- Conditions
- Multiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative DiseasesChronic Myeloproliferative DisordersFanconi AnemiaAplastic AnemiaLeukemiaLymphoma
- Interventions
- Biological: anti-thymocyte globulinBiological: graft-versus-tumor induction therapyBiological: sargramostimBiological: therapeutic allogeneic lymphocytesProcedure: allogeneic bone marrow transplantationProcedure: peripheral blood stem cell transplantationProcedure: umbilical cord blood transplantation
- Registration Number
- NCT00053989
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief Summary
RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well chemotherapy followed by donor peripheral stem cell transplant works in treating patients with hematologic cancer or aplastic anemia.
- Detailed Description
OBJECTIVES:
* Determine the safety and toxic effects of nonmyeloablative allogeneic peripheral blood stem cell transplantation in patients with a hematologic malignancy or aplastic anemia.
* Determine clinical response and overall outcome of patients treated with this regimen.
* Determine the incidence of graft-vs-tumor effect, graft-vs-host disease, and chimerism in patients treated with this regimen.
OUTLINE:
* Preparative regimen:
* Matched related and unrelated donor transplantation:
* Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine IV over 30 minutes on days -5 to -1.
* Cord blood transplantation:
* Patients receive the same regimen as above plus anti-thymocyte globulin IV over 4 hours on days -3 to -1.
* Graft-vs-host disease (GVHD) prophylaxis:
* Matched related and unrelated donor transplantation:
* Patients receive oral tacrolimus (or IV) once daily and oral mycophenolate mofetil (MMF) (or IV) twice daily on days -1 to 60 followed by tapering\* of this regimen. Patients then receive methotrexate IV on days 1, 3, and 6.
* Cord blood transplantation:
* Patients receive tacrolimus and MMF in the same regimen as above plus methylprednisolone twice daily on days 1-19 or until blood counts recover.
* Allogeneic stem cell reinfusion: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients then receive sargramostim (GM-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover.
* Donor lymphocyte infusion (DLI): Patients not converting to 100% donor T-cell chimerism by day 120 and showing signs of progresson of disease after tacrolimus and MMF withdrawal may receive DLI every 8 weeks for up to 3 infusions. Cord blood recipients do not receive DLI.
Patients are followed at day 100-120, every 3 months for 2 years, and then every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 6-7 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All patients peripheral blood stem cell transplantation All patients enrolled on study All patients therapeutic allogeneic lymphocytes All patients enrolled on study All patients tacrolimus All patients enrolled on study All patients sargramostim All patients enrolled on study All patients methylprednisolone All patients enrolled on study All patients anti-thymocyte globulin All patients enrolled on study All patients graft-versus-tumor induction therapy All patients enrolled on study All patients cyclophosphamide All patients enrolled on study All patients fludarabine phosphate All patients enrolled on study All patients mycophenolate mofetil All patients enrolled on study All patients allogeneic bone marrow transplantation All patients enrolled on study All patients umbilical cord blood transplantation All patients enrolled on study
- Primary Outcome Measures
Name Time Method Day 100 Best Response from start of conditioning on day -6 or -5 through day +100 after HSC infusion Best disease response measured within 100 days from hematopoietic stem cell (HSC) infusion on day 0 using disease specific response criteria defined in the protocol
Day 100 TRM from start or conditioning (day -6 or -5) through day +100 after HSC infusion treatment related mortality within 100 days from hematopoietic stem cell (HSC) infusion on day 0
- Secondary Outcome Measures
Name Time Method PFS 1 year Progression free survival defined as time from HSC infusion (day 0) until progression of disease or death due to any cause. Patients are censored if alive without disease progression through 1 year after HSC infusion
Acute GvHD Day +100 overall grade II-IV acute GvHD
OS 1 year Overall survival with events defined as death due to any cause and censored patients are alive as of 1 year post HSC infusion
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States