Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal 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 cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil before the transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well umbilical cord blood stem cell transplant works in treating patients with hematologic cancer or other disease.
Multiple Myeloma and Plasma Cell Neoplasm
Drug: Fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: umbilical cord blood transplantation
Radiation: total-body irradiation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Double Cord Blood Stem Cell Transplantation in Patients With Hematologic Malignancies|
- Engraftment [ Time Frame: 60 days post transplantation ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: Within 100 days post transplantation ] [ Designated as safety issue: No ]
- Rate of graft failure [ Time Frame: Within 23 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Busulfan Cytarabine Fludarabine Tacrolimus Mycophenolate
Busulfan 3mg/kg-3hrs; Ara-C 30mg/M2; Fludarabine phosphate:25mg/M2/day; Tacrolimus:0.015mg/kg every 12 hrs
3 mg/kg intravenously over 3 hours
Other Names:Drug: Cytarabine
Patients with previous history of CNS involvement will receive pre-transplant intrathecal Cytarabine (Ara-C) (30 mg/M2) therapy.
Other Names:Drug: Fludarabine phosphate
25 mg/M2/day IV
Other Name: FludaraDrug: mycophenolate mofetil
Orally at the dose of 1 gm every 8 hours.
Other Name: CellceptDrug: tacrolimus
0.015 mg/kg IV every 12 hours by continuous infusion.
Other Names:Procedure: allogeneic hematopoietic stem cell transplantation
10 days post drug interventionProcedure: umbilical cord blood transplantation
10 days post drug interventionRadiation: total-body irradiation
10 days post drug intervention
- Determine the efficacy of double umbilical cord blood stem cell transplantation using a conditioning regimen comprising lower doses of busulfan and fludarabine phosphate and low-dose total body irradiation, in terms of stem cell engraftment at 60 days post transplantation, in patients with hematologic cancer or other diseases.
- Determine the merits of conducting a larger, comparative study of this regimen.
- Determine mortality within 100 days of transplantation in these patients.
OUTLINE: This is a pilot study.
- Reduced-intensity conditioning regimen: Patients receive busulfan IV over 3 hours on days -9 to -8 and fludarabine phosphate IV on days -7 to -3. Patients then undergo low-dose total body irradiation on day 0.
- Graft-versus-host disease prophylaxis: Patients receive tacrolimus IV twice daily and mycophenolate orally or IV three times daily beginning on day -3.
- CNS prophylaxis and/or treatment: Patients with a history of CNS involvement receive prophylactic cytarabine (Ara-C) intrathecally (IT) prior to transplant. Patients also undergo lumbar puncture (LP) to test for active CNS disease. Patients with cerebrospinal fluid positive for leukemia receive Ara-C IT every 2-3 days until a repeat LP shows no remaining leukemic cells. Three days after the last LP and after one final dose of Ara-C, patients begin the conditioning regimen.
- Double umbilical cord blood (UCB) donor stem cell transplantation (SCT): Patients undergo double UCB donor SCT on day 0.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423826
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201-1379|
|Contact: Voravit Ratanatharathorn, MD 313-576-8755 email@example.com|
|Sub-Investigator: Muneer Abidi, M.D.|
|Sub-Investigator: Lois Ayash, M.D.|
|Sub-Investigator: Ronald Chu, M.D.|
|Sub-Investigator: Abhinav Deol|
|Sub-Investigator: Yaddanapudi Ravindranath|
|Sub-Investigator: Sureyya Savasan|
|Sub-Investigator: Joseph Uberti, M.D.|
|Study Chair:||Voravit Ratanatharathorn, MD||Barbara Ann Karmanos Cancer Institute|